Imatinib Mesylate in Treating Patients With Recurrent Brain Tumor

• Sponsor: Alliance for Clinical Trials in Oncology (Other)
• Overall Status: Completed
• CT.gov ID: NCT00049127
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 64
• Locations: 229
• Arms: 2
• Actual Duration (Months): 195
• Patients Per Site: 0.3
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

This phase I/II trial is studying the side effects and best dose of imatinib mesylate and to see how well it works in treating patients with a recurrent brain tumor that has not responded to previous surgery and radiation therapy. Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.

Condition or Disease	Intervention/Treatment	Phase
Adult Anaplastic Oligodendroglioma; Adult Mixed Glioma; Adult Oligodendroglioma; Recurrent Adult Brain Neoplasm	Drug: Imatinib Mesylate; Other: Laboratory Biomarker Analysis; Other: Pharmacological Study	Phase 1/Phase 2

Detailed Description

PRIMARY OBJECTIVES:

1. To identify the maximum tolerated dose of imatinib (imatinib mesylate) in patients with recurrent oligodendroglioma and mixed oligoastrocytoma that are currently on enzyme inducing anticonvulsant therapy. (Study 1) II. To assess the efficacy of imatinib in patients with recurrent oligodendrogliomas and mixed oligoastrocytomas (with pathologic evidence of oligodendrogliomatous component) as measured by progression-free survival, response, and overall survival. (Study 2) III. To acquire pilot data on a patient group not traditionally eligible for recurrent oligodendroglioma and mixed oligoastrocytoma clinical trials (those having > 2 prior chemotherapy regimens or 2 prior chemotherapy regimens for recurrent/progressive disease). (Study 3) IV. To examine the toxicity and safety of imatinib in patients with recurrent oligodendrogliomas and mixed oligoastrocytomas (with pathologic evidence of oligodendrogliomatous component). (Studies 1, 2, and 3) V. To perform a preliminary correlative study of 1p/19q alterations, alpha platelet-derived growth factor receptor (PDFGR) gene amplification and levels of related downstream signaling elements in tumor tissue, with clinical study endpoints. (Studies 1, 2, and 3) VI. To perform a descriptive correlative analysis of steady state pharmacokinetic data regarding imatinib and active metabolites with the study endpoints. (Studies 1, 2, and 3)

OUTLINE: This is a phase I, dose-escalation study followed by a phase II and a pilot study.

Study Design

• Study Type: Interventional
• Actual Enrollment: 64 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase I/II Trial of Imatinib Mesylate; (Gleevec; STI571) in Treatment of Recurrent Oligodendroglioma and Mixed Oligoastrocytoma
• Actual Study Start Date: Jun 1, 2003
• Actual Primary Completion Date: Aug 1, 2011
• Actual Study Completion Date: Sep 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Phase II (Group 1) Patients receive imatinib mesylate PO, at the MTD determined in phase I, BID for 4 weeks.	Drug: Imatinib Mesylate; Given PO; Other Names: CGP 57148 CGP57148B Gleevec Glivec STI 571 STI-571 STI571 ; Other: Laboratory Biomarker Analysis; Optional correlative studies; Other: Pharmacological Study; Optional correlative studies
Experimental: Phase II (Group 2) Patients receive standard-dose imatinib mesylate PO BID for 4 weeks.	Drug: Imatinib Mesylate; Given PO; Other Names: CGP 57148 CGP57148B Gleevec Glivec STI 571 STI-571 STI571 ; Other: Laboratory Biomarker Analysis; Optional correlative studies; Other: Pharmacological Study; Optional correlative studies

Outcome Measures

Primary Outcome Measures

1. 6-month Progression-free Survival (PFS), Defined as a Patient Being Alive and Progression-free 183 Days After the Date of Registration. [6 months]

   The proportion of successes will be estimated using the Binomial point estimator (number of successes divided by the total number of evaluable patients) and the Binomial 90% confidence interval estimated using the Duffy-Santer algorithm. Progression is defined using response criteria (the neurologic examination and the MRI and/or CT), >25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions.

Secondary Outcome Measures

1. Confirmed Response (i.e., an Objective Status of Complete Response (CR), Partial Response (PR), or Regression (REGR) on 2 Successive Evaluations at Least 4 Weeks Apart After the Start of Study Treatment). [Up to 5 years]

   Complete Response (CR) is defined using response criteria (the neurologic examination and the Magnetic resonance imaging (MRI) and/or Computerized Tomography (CT)), total disappearance of all tumor with patient off corticosteroids or only on adrenal replacement maintenance. Partial Response (PR) is defined using response criteria (the neurologic examination and the MRI and/or CT), >=50% reduction in product of perpendicular diameters of contrast enhancement or mass with no new lesions with the patient being on stable or decreased steroid dose. Regression (REGR) is defined using response criteria (the neurologic examination and the MRI and/or CT), unequivocal reduction in size of contrast-enhancement or decrease in mass effect as agreed upon independently by primary physician and quality control physicians; no new lesions. Patient should be on stable or decreased steroid dose.

2. Percentage of Patients Progression-free [Time from study registration to date of disease progression or last follow-up, assessed up to 5 years]

   The percentage of patient progression-free at 12 months, 18 months, and PFS will be estimated. Kaplan-Meier survival curves and logrank tests will be used to estimate progression-time distributions. Progression is defined using response criteria (the neurologic examination and the MRI and/or CT), >25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions.

3. Overall Time to Death [Time from date of registration to date of death due to any cause or last follow-up, assessed up to 5 years]

   Kaplan-Meier survival curves and logrank tests will be used to estimate survival distributions.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Study 1 Arm C:

• Currently on anticonvulsants which can induce cytochrome p450 (phenytoin, carbamazepine, barbiturates, primidone and if unsure contact study chair)

• =< 2 prior chemotherapy regimens (with maximum of 1 prior chemotherapy regimen for recurrent disease)

• Study 2 Arms A and B:

• On or off anticonvulsants

• =< 2 prior chemotherapy regimens (with maximum of 1 prior chemotherapy regimen for recurrent disease)

• Study 3 Arms D and E:

• On or off anticonvulsants

• 2 chemotherapy regimens or 2 prior chemotherapy regimens for progressive/recurrent disease

• All Arms:

• Histological confirmation of a grade 2-4 oligodendroglioma, or mixed oligoastrocytoma grade 2-4 containing oligodendrogliomatous component on central pathology review prior to study registration, and a diagnosis of recurrence; tissues from all available prior surgeries should be sent, in particular those from time of initial diagnosis

• Measurable or evaluable disease by magnetic resonance imaging (MRI) or computed tomography (CT) scan

• Fixed dose of corticosteroids (or no corticosteroids) for at least 1 week prior to the pre-study baseline scan

• Patients undergoing surgery for initial or progressive disease, must be at least 2 weeks from the date of surgery, must have recovered from the effects of their surgery, and must have unequivocal tumor growth on the pre-study baseline neuroimaging study as compared to the first post-operative scan, unless there is a separate lesion or residual disease compatible with tumor that is not within the surgical bed

• Unequivocal evidence of tumor progression by MRI or CT scan performed =< 21days prior to study registration

• Must have failed surgery/radiotherapy (RT) and Temozolomide or nitrosourea based therapy

• = 12 weeks since the completion of RT

• Absolute neutrophil count (ANC) >= 1500/mm^3

• Platelets (PLT) >= 100,000/mm^3

• Hemoglobin (Hgb) >= 9 g/dL

• Total bilirubin =< 1.5 mg/dL

• Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =< 3 x upper limit of normal (ULN)

• Creatinine =< 2.0 mg/dL

• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2

• = 6 weeks since the last day of nitrosourea-based chemotherapy prior to study entry

• = 4 weeks from any investigational agents prior to study entry

• = 4 weeks from other chemotherapy prior to study entry

• = 2 weeks from vincristine and biologic non-cytotoxic agents, e.g., tamoxifen, thalidomide, cis-retinoic acid, interferon, etc, prior to study entry

• Patients or designated individual(s) with durable medical power of attorney for the patient must be able to provide informed, written consent, and complete any required study questionnaire(s) within the specifications of this study

Exclusion Criteria:

• All Arms

• Receiving warfarin or heparin

• Received prior stereotactic radiosurgery, interstitial brachytherapy, or interstitial chemotherapy including carmustine (BCNU) wafers unless there is a separate lesion on MRI, which is not part of the previous treatment field

• Active uncontrolled infection

• History of myocardial infarction =< 6 months or congestive heart failure (CHF) requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias; patients must have a New York Heart Association (NYHA) of class II or less; (NYHA class I: patients with no limitation of activities; they suffer no symptoms from ordinary activities; class II: patients with slight, mild limitation of activity; they are comfortable with rest or with mild exertion; class III: patients with marked limitation of activity; they are comfortable only at rest; class IV: patients who should be at complete rest, confined to bed or chair; any physical activity brings on discomfort and symptoms occur at rest)

• Other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the interpretation of potential drug-induced toxicities

• Women of child-bearing potential, pregnant or nursing; such patients must have a negative pregnancy test (b-HCG) =< 7 days prior to study registration

• Men or women of childbearing potential, not willing to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device [IUD], surgical sterilization, subcutaneous implants, or abstinence, etc.); the efficacy of oral contraceptives may be decreased in patients who receive p450-inducing anticonvulsants; for these patients, use of a second mode of contraception is recommended; patients of childbearing potential must utilize effective contraception and avoid becoming pregnant or fathering a child for 6 months after completing study drug

• Other active malignancy, besides skin carcinomas (must not be melanoma)

• Concomitant serious immunocompromised status (other than that related to concomitant steroids); patients that are human immunodeficiency virus (HIV) positive are eligible, provided that there is no other reason for exclusion, based on the eligibility as outlined elsewhere in this section

• Significant intratumoral hemorrhage on baseline MRI or CT, or other history of significant intratumoral hemorrhage

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Arizona	Scottsdale	Arizona	United States	85259
2	Saint Francis Hospital and Medical Center	Hartford	Connecticut	United States	06105
3	Mayo Clinic in Florida	Jacksonville	Florida	United States	32224-9980
4	Rush - Copley Medical Center	Aurora	Illinois	United States	60504
5	Bromenn Lifecare Center	Bloomington	Illinois	United States	61701
6	Saint Joseph Medical Center	Bloomington	Illinois	United States	61701
7	Graham Hospital Association	Canton	Illinois	United States	61520
8	Memorial Hospital	Carthage	Illinois	United States	62321
9	Eureka Hospital	Eureka	Illinois	United States	61530
10	Galesburg Cottage Hospital	Galesburg	Illinois	United States	61401
11	Illinois CancerCare Galesburg	Galesburg	Illinois	United States	61401
12	Western Illinois Cancer Treatment Center	Galesburg	Illinois	United States	61401
13	Mason District Hospital	Havana	Illinois	United States	62644
14	Hopedale Medical Complex - Hospital	Hopedale	Illinois	United States	61747
15	Joliet Oncology-Hematology Associates Limited	Joliet	Illinois	United States	60435
16	Kewanee Hospital	Kewanee	Illinois	United States	61443
17	Mcdonough District Hospital	Macomb	Illinois	United States	61455
18	Garneau, Stewart C MD (UIA Investigator)	Moline	Illinois	United States	61265
19	Porubcin, Michael MD (UIA Investigator)	Moline	Illinois	United States	61265
20	Sharis, Christine M MD (UIA Investigator)	Moline	Illinois	United States	61265
21	Stoffel, Thomas J MD (UIA Investigator)	Moline	Illinois	United States	61265
22	Vigliotti, Antonio, P.G. M.D. (UIA Investigator)	Moline	Illinois	United States	61265
23	Bromenn Regional Medical Center	Normal	Illinois	United States	61761
24	Community Cancer Center Foundation	Normal	Illinois	United States	61761
25	Illinois CancerCare-Ottawa Clinic	Ottawa	Illinois	United States	61350
26	Ottawa Regional Hospital and Healthcare Center	Ottawa	Illinois	United States	61350
27	Pekin Cancer Treatment Center	Pekin	Illinois	United States	61554
28	Pekin Hospital	Pekin	Illinois	United States	61554
29	Methodist Medical Center of Illinois	Peoria	Illinois	United States	61603
30	Proctor Hospital	Peoria	Illinois	United States	61614
31	Illinois CancerCare-Peoria	Peoria	Illinois	United States	61615
32	Illinois Oncology Research Association CCOP	Peoria	Illinois	United States	61615
33	OSF Saint Francis Medical Center	Peoria	Illinois	United States	61637
34	Illinois Valley Hospital	Peru	Illinois	United States	61354
35	Valley Radiation Oncology	Peru	Illinois	United States	61354
36	Perry Memorial Hospital	Princeton	Illinois	United States	61356
37	Sarah Culbertson Memorial Hospital	Rushville	Illinois	United States	62681
38	Saint Margaret's Hospital	Spring Valley	Illinois	United States	61362
39	Carle Cancer Center	Urbana	Illinois	United States	61801
40	Carle Clinic-Urbana Main	Urbana	Illinois	United States	61801
41	Franciscan Saint Anthony Health-Michigan City	Michigan City	Indiana	United States	46360
42	McFarland Clinic PC-William R Bliss Cancer Center	Ames	Iowa	United States	50010
43	Constantinou, Costas L MD (UIA Investigator)	Bettendorf	Iowa	United States	52722
44	Saint Anthony Regional Hospital	Carroll	Iowa	United States	51401
45	Saint Luke's Hospital	Cedar Rapids	Iowa	United States	52402
46	Cedar Rapids Oncology Association	Cedar Rapids	Iowa	United States	52403
47	Mercy Hospital	Cedar Rapids	Iowa	United States	52403
48	Oncology Associates at Mercy Medical Center	Cedar Rapids	Iowa	United States	52403
49	Medical Oncology and Hematology Associates-West Des Moines	Clive	Iowa	United States	50325
50	Alegent Health Mercy Hospital	Council Bluffs	Iowa	United States	51503
51	Mercy Capitol	Des Moines	Iowa	United States	50307
52	Iowa Methodist Medical Center	Des Moines	Iowa	United States	50309
53	Iowa Oncology Research Association CCOP	Des Moines	Iowa	United States	50309
54	Medical Oncology and Hematology Associates-Des Moines	Des Moines	Iowa	United States	50309
55	Medical Oncology and Hematology Associates-Laurel	Des Moines	Iowa	United States	50314
56	Mercy Medical Center - Des Moines	Des Moines	Iowa	United States	50314
57	Iowa Lutheran Hospital	Des Moines	Iowa	United States	50316
58	Mercy Medical Center - North Iowa	Mason City	Iowa	United States	50401
59	Community Memorial Hospital	Missouri Valley	Iowa	United States	51555
60	Burgess Memorial Hospital	Onawa	Iowa	United States	51040
61	Siouxland Regional Cancer Center	Sioux City	Iowa	United States	51101-1733
62	Siouxland Regional Cancer Center	Sioux City	Iowa	United States	51101
63	Mercy Medical Center-Sioux City	Sioux City	Iowa	United States	51104
64	Saint Luke's Regional Medical Center	Sioux City	Iowa	United States	51104
65	Hospital District Sixth of Harper County	Anthony	Kansas	United States	67003
66	Memorial Hospital of Arkansas City	Arkansas City	Kansas	United States	67005
67	Cancer Center of Kansas - Chanute	Chanute	Kansas	United States	66720
68	Cancer Center of Kansas - Dodge City	Dodge City	Kansas	United States	67801
69	Cancer Center of Kansas - El Dorado	El Dorado	Kansas	United States	67042
70	Cancer Center of Kansas - Fort Scott	Fort Scott	Kansas	United States	66701
71	Cancer Center of Kansas-Independence	Independence	Kansas	United States	67301
72	Cancer Center of Kansas-Kingman	Kingman	Kansas	United States	67068
73	Lawrence Memorial Hospital	Lawrence	Kansas	United States	66044
74	Cancer Center of Kansas-Liberal	Liberal	Kansas	United States	67901
75	Southwest Medical Center	Liberal	Kansas	United States	67901
76	Cancer Center of Kansas - Newton	Newton	Kansas	United States	67114
77	Cancer Center of Kansas - Ottawa	Ottawa	Kansas	United States	66067
78	Cancer Center of Kansas - Parsons	Parsons	Kansas	United States	67357
79	Cancer Center of Kansas - Pratt	Pratt	Kansas	United States	67124
80	Cancer Center of Kansas - Salina	Salina	Kansas	United States	67401
81	Cancer Center of Kansas - Wellington	Wellington	Kansas	United States	67152
82	Associates In Womens Health	Wichita	Kansas	United States	67208
83	Cancer Center of Kansas-Wichita Medical Arts Tower	Wichita	Kansas	United States	67208
84	Cancer Center of Kansas - Main Office	Wichita	Kansas	United States	67214
85	Via Christi Regional Medical Center	Wichita	Kansas	United States	67214
86	Wichita CCOP	Wichita	Kansas	United States	67214
87	Cancer Center of Kansas - Winfield	Winfield	Kansas	United States	67156
88	Bixby Medical Center	Adrian	Michigan	United States	49221
89	Hickman Cancer Center	Adrian	Michigan	United States	49221
90	Saint Joseph Mercy Hospital	Ann Arbor	Michigan	United States	48106-0995
91	Michigan Cancer Research Consortium CCOP	Ann Arbor	Michigan	United States	48106
92	Oakwood Hospital and Medical Center	Dearborn	Michigan	United States	48124
93	Saint John Hospital and Medical Center	Detroit	Michigan	United States	48236
94	Hurley Medical Center	Flint	Michigan	United States	48502
95	Genesys Regional Medical Center-West Flint Campus	Flint	Michigan	United States	48532
96	Allegiance Health	Jackson	Michigan	United States	49201
97	Center for Hematology- Oncology of Southern Michigan PLC	Jackson	Michigan	United States	49201
98	Sparrow Hospital	Lansing	Michigan	United States	48912
99	Saint Mary Mercy Hospital	Livonia	Michigan	United States	48154
100	Mercy Memorial Hospital	Monroe	Michigan	United States	48162
101	Toledo Clinic Cancer Centers-Monroe	Monroe	Michigan	United States	48162
102	Saint Joseph Mercy Oakland	Pontiac	Michigan	United States	48341
103	Saint Joseph Mercy Port Huron	Port Huron	Michigan	United States	48060
104	Saint Mary's of Michigan	Saginaw	Michigan	United States	48601
105	Saint John Macomb-Oakland Hospital	Warren	Michigan	United States	48093
106	Medini, Eitan MD (UIA Investigator)	Alexandria	Minnesota	United States	56308
107	Brainerd Medical Center Inc	Brainerd	Minnesota	United States	56401
108	Essentia Health Saint Joseph's Medical Center	Brainerd	Minnesota	United States	56401
109	Fairview Ridges Hospital	Burnsville	Minnesota	United States	55337
110	Mercy Hospital	Coon Rapids	Minnesota	United States	55433
111	Essentia Health Cancer Center	Duluth	Minnesota	United States	55805
112	Essentia Health Saint Mary's Medical Center	Duluth	Minnesota	United States	55805
113	Miller-Dwan Hospital	Duluth	Minnesota	United States	55805
114	Fairview-Southdale Hospital	Edina	Minnesota	United States	55435
115	Etzell, Paul S MD (UIA Investigator)	Fergus Falls	Minnesota	United States	56537
116	Swenson, Wade II, MD (UIA Investigator)	Fergus Falls	Minnesota	United States	56537
117	Unity Hospital	Fridley	Minnesota	United States	55432
118	Hutchinson Area Health Care	Hutchinson	Minnesota	United States	55350
119	Meeker County Memorial Hospital	Litchfield	Minnesota	United States	55355
120	Minnesota Oncology Hematology PA-Maplewood	Maplewood	Minnesota	United States	55109
121	Saint John's Hospital - Healtheast	Maplewood	Minnesota	United States	55109
122	Abbott-Northwestern Hospital	Minneapolis	Minnesota	United States	55407
123	Virginia Piper Cancer Institute	Minneapolis	Minnesota	United States	55407
124	Hennepin County Medical Center	Minneapolis	Minnesota	United States	55415
125	Chippewa County - Montevideo Hospital	Montevideo	Minnesota	United States	56265
126	North Memorial Medical Health Center	Robbinsdale	Minnesota	United States	55422
127	Mayo Clinic	Rochester	Minnesota	United States	55905
128	Coborn Cancer Center at Saint Cloud Hospital	Saint Cloud	Minnesota	United States	56303
129	Saint Cloud Hospital	Saint Cloud	Minnesota	United States	56303
130	Metro-Minnesota NCI Community Oncology Research Program	Saint Louis Park	Minnesota	United States	55416
131	Park Nicollet Clinic - Saint Louis Park	Saint Louis Park	Minnesota	United States	55416
132	Regions Hospital	Saint Paul	Minnesota	United States	55101
133	Saint Joseph's Hospital - Healtheast	Saint Paul	Minnesota	United States	55102
134	United Hospital	Saint Paul	Minnesota	United States	55102
135	Adult and Pediatric Urology PLLP	Sartell	Minnesota	United States	56377
136	Saint Francis Regional Medical Center	Shakopee	Minnesota	United States	55379
137	Lakeview Hospital	Stillwater	Minnesota	United States	55082
138	Ridgeview Medical Center	Waconia	Minnesota	United States	55387
139	Rice Memorial Hospital	Willmar	Minnesota	United States	56201
140	Minnesota Oncology and Hematology PA-Woodbury	Woodbury	Minnesota	United States	55125
141	Woodwinds Health Campus	Woodbury	Minnesota	United States	55125
142	Montana Cancer Consortium NCORP	Billings	Montana	United States	59101
143	Northern Rockies Radiation Oncology Center	Billings	Montana	United States	59101
144	Saint Vincent Healthcare	Billings	Montana	United States	59101
145	Frontier Cancer Center and Blood Institute-Billings	Billings	Montana	United States	59102
146	Billings Clinic Cancer Center	Billings	Montana	United States	59107
147	Deaconess Medical Center	Billings	Montana	United States	59107
148	Bozeman Deaconess Cancer Center	Bozeman	Montana	United States	59715
149	Bozeman Deaconess Hospital	Bozeman	Montana	United States	59715
150	Internal Medicine of Bozeman	Bozeman	Montana	United States	59715
151	Saint James Community Hospital and Cancer Treatment Center	Butte	Montana	United States	59701
152	Benefis Healthcare- Sletten Cancer Institute	Great Falls	Montana	United States	59405
153	Berdeaux, Donald MD (UIA Investigator)	Great Falls	Montana	United States	59405
154	Great Falls Clinic	Great Falls	Montana	United States	59405
155	Northern Montana Hospital	Havre	Montana	United States	59501
156	Saint Peter's Community Hospital	Helena	Montana	United States	59601
157	Glacier Oncology PLLC	Kalispell	Montana	United States	59901
158	Kalispell Medical Oncology	Kalispell	Montana	United States	59901
159	Kalispell Regional Medical Center	Kalispell	Montana	United States	59901
160	Eastern Montana Cancer Center	Miles City	Montana	United States	59301
161	Community Medical Hospital	Missoula	Montana	United States	59801
162	Montana Cancer Specialists	Missoula	Montana	United States	59802
163	Saint Patrick Hospital - Community Hospital	Missoula	Montana	United States	59802
164	Guardian Oncology and Center for Wellness	Missoula	Montana	United States	59804
165	Fremont Area Medical Center	Fremont	Nebraska	United States	68025
166	Bryan LGH Medical Center West	Lincoln	Nebraska	United States	68502
167	Bryan LGH Medical Center East	Lincoln	Nebraska	United States	68506
168	Nebraska Cancer Research Center	Lincoln	Nebraska	United States	68510
169	Saint Elizabeth Regional Medical Center	Lincoln	Nebraska	United States	68510
170	Missouri Valley Cancer Consortium	Omaha	Nebraska	United States	68106
171	Alegent Health Immanuel Medical Center	Omaha	Nebraska	United States	68122
172	Alegent Health Bergan Mercy Medical Center	Omaha	Nebraska	United States	68124
173	Creighton University Medical Center	Omaha	Nebraska	United States	68131
174	Midlands Community Hospital	Papillion	Nebraska	United States	68046
175	Mount Sinai Medical Center	New York	New York	United States	10029
176	Rutherford Hospital	Rutherfordton	North Carolina	United States	28139
177	Southeast Cancer Consortium-Upstate NCORP	Winston-Salem	North Carolina	United States	27104
178	Mid Dakota Clinic	Bismarck	North Dakota	United States	58501
179	Saint Alexius Medical Center	Bismarck	North Dakota	United States	58501
180	Sanford Bismarck Medical Center	Bismarck	North Dakota	United States	58501
181	Toledo Clinic Cancer Centers-Bowling Green	Bowling Green	Ohio	United States	43402
182	North Coast Cancer Care-Clyde	Clyde	Ohio	United States	43410
183	Hematology Oncology Center Incorporated	Elyria	Ohio	United States	44035
184	Mercy Cancer Center-Elyria	Elyria	Ohio	United States	44035
185	Blanchard Valley Hospital	Findlay	Ohio	United States	45840
186	Fremont Memorial Hospital	Fremont	Ohio	United States	43420
187	Cole, Sharon, K. M.D. (UIA Investigator)	Kenton	Ohio	United States	43326
188	Lima Memorial Hospital	Lima	Ohio	United States	45804
189	Saint Luke's Hospital	Maumee	Ohio	United States	43537
190	Toledo Clinic Cancer Centers-Maumee	Maumee	Ohio	United States	43537
191	Toledo Radiation Oncology at Northwest Ohio Onocolgy Center	Maumee	Ohio	United States	43537
192	Fisher-Titus Medical Center	Norwalk	Ohio	United States	44857
193	Saint Charles Hospital	Oregon	Ohio	United States	43616
194	Toledo Clinic Cancer Centers-Oregon	Oregon	Ohio	United States	43616
195	Firelands Regional Medical Center	Sandusky	Ohio	United States	44870
196	North Coast Cancer Care	Sandusky	Ohio	United States	44870
197	Flower Hospital	Sylvania	Ohio	United States	43560
198	Mercy Hospital of Tiffin	Tiffin	Ohio	United States	44883
199	The Toledo Hospital/Toledo Children's Hospital	Toledo	Ohio	United States	43606
200	Saint Vincent Mercy Medical Center	Toledo	Ohio	United States	43608
201	University of Toledo	Toledo	Ohio	United States	43614
202	Toledo Community Hospital Oncology Program CCOP	Toledo	Ohio	United States	43617
203	Mercy Saint Anne Hospital	Toledo	Ohio	United States	43623
204	Stark, Michael, Edward. M.D. (UIA Investigator)	Toledo	Ohio	United States	43623
205	Toledo Clinic Cancer Centers-Toledo	Toledo	Ohio	United States	43623
206	Fulton County Health Center	Wauseon	Ohio	United States	43567
207	Lehigh Valley Hospital-Cedar Crest	Allentown	Pennsylvania	United States	18103
208	Medical Center Clinic-Butler Office	Butler	Pennsylvania	United States	16001
209	Geisinger Medical Center	Danville	Pennsylvania	United States	17822
210	Geisinger Medical Center-Cancer Center Hazleton	Hazleton	Pennsylvania	United States	18201
211	Sharon Regional Cancer Center	Hermitage	Pennsylvania	United States	16148
212	Allegheny General Hospital	Pittsburgh	Pennsylvania	United States	15212
213	Medical Center Clinic-Allegheny General Hospital	Pittsburgh	Pennsylvania	United States	15212
214	Guthrie Medical Group PC-Robert Packer Hospital	Sayre	Pennsylvania	United States	18840
215	Geisinger Medical Group	State College	Pennsylvania	United States	16801
216	Geisinger Wyoming Valley/Henry Cancer Center	Wilkes-Barre	Pennsylvania	United States	18711
217	AnMed Health Hospital	Anderson	South Carolina	United States	29621
218	Spartanburg Medical Center	Spartanburg	South Carolina	United States	29303
219	Rapid City Regional Hospital	Rapid City	South Dakota	United States	57701
220	Sanford Cancer Center-Oncology Clinic	Sioux Falls	South Dakota	United States	57104
221	Sanford NCI Community Oncology Research Program of the North Central Plains	Sioux Falls	South Dakota	United States	57104
222	Avera Cancer Institute	Sioux Falls	South Dakota	United States	57105
223	Avera McKennan Hospital and University Health Center	Sioux Falls	South Dakota	United States	57105
224	Medical X-Ray Center	Sioux Falls	South Dakota	United States	57105
225	Sanford USD Medical Center - Sioux Falls	Sioux Falls	South Dakota	United States	57117-5134
226	University of Virginia Cancer Center	Charlottesville	Virginia	United States	22908
227	Fredericksburg Oncology Inc	Fredericksburg	Virginia	United States	22401
228	Rocky Mountain Oncology	Casper	Wyoming	United States	82609
229	Welch Cancer Center	Sheridan	Wyoming	United States	82801

Sponsors and Collaborators

• Alliance for Clinical Trials in Oncology
• National Cancer Institute (NCI)

Investigators

• Study Chair: Kurt Jaeckle, MD, Mayo

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alliance for Clinical Trials in Oncology
• ClinicalTrials.gov Identifier: NCT00049127
• Other Study ID Numbers: N0272; NCI-2011-01576; NCCTG-N0272; CDR0000257812; U10CA025224
• First Posted: Jan 27, 2003
• Last Update Posted: Oct 21, 2019
• Last Verified: Oct 1, 2019

• Additional relevant MeSH terms: Oligodendroglioma; Brain Neoplasms; Glioma; Recurrence; Imatinib Mesylate

Study Results

Participant Flow

Arm/Group Title	Study 1 Arm C	Study 2 Arm A	Study 2 Arm B	Study 3 Arm D	Study 3 Arm E
Arm/Group Description	Phase I patients on enzyme-inducing anticonvulsants (EIACs) and <=2 prior regimens Imatinib at assigned dose. Escalation of cohorts-of-3 per section 7.1 of the protocol. Assigned dose will be administered p.o. twice daily in divided doses.	Phase II patients on enzyme-inducing anticonvulsants (EIACs) and <=2 prior regimens Imatinib at Maximum Tolerated Dose (MTD) from Study 1 mg p.o. bid daily	Phase II patients not on enzyme-inducing anticonvulsants (EIACs) and <=2 prior regimens Imatinib at 300 mg b.i.d.	Phase II patients on enzyme-inducing anticonvulsants (EIACs) and >2 prior regimens Imatinib at Maximum Tolerated Dose (MTD) from Study 1 mg p.o. bid daily	Phase II patients not on enzyme-inducing anticonvulsants (EIACs) and >2 prior regimens Imatinib at 300 mg b.i.d.
Period Title: Overall Study
STARTED	12	0	40	0	12
COMPLETED	12	0	39	0	12
NOT COMPLETED	0	0	1	0	0

Baseline Characteristics

Arm/Group Title	Study 1 Arm C	Study 2 Arm A	Study 2 Arm B	Study 3 Arm D	Study 3 Arm E	Total
Arm/Group Description	Phase I patients on EIACs and <=2 prior regimens	Phase II patients on EIACs and <=2 prior regimens	Phase II patients not on EIACs and <=2 prior regimens	Phase II patients on EIACs and >2 prior regimens	Phase II patients not on EIACs and >2 prior regimens	Total of all reporting groups
Overall Participants	12	0	39	0	12	63
Age (years) [Median (Full Range) ]
participants	45	46	47	46
Sex: Female, Male (Count of Participants)
Female	1 8.3%	17 Infinity	4 10.3%	22 Infinity
Male	11 91.7%	22 Infinity	8 20.5%	41 Infinity
Performance Score (participants) [Number]
0	7 58.3%	10 Infinity	6 15.4%	23 Infinity
1	4 33.3%	23 Infinity	4 10.3%	31 Infinity
2	1 8.3%	6 Infinity	2 5.1%	9 Infinity

Outcome Measures

1. Primary Outcome

Title	6-month Progression-free Survival (PFS), Defined as a Patient Being Alive and Progression-free 183 Days After the Date of Registration.
Description	The proportion of successes will be estimated using the Binomial point estimator (number of successes divided by the total number of evaluable patients) and the Binomial 90% confidence interval estimated using the Duffy-Santer algorithm. Progression is defined using response criteria (the neurologic examination and the MRI and/or CT), >25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Study 1 Arm C	Study 2 Arm A	Study 2 Arm B	Study 3 Arm D	Study 3 Arm E
Arm/Group Description	Phase I patients on EIACs and <=2 prior regimens	Phase II patients on EIACs and <=2 prior regimens	Phase II patients not on EIACs and <=2 prior regimens	Phase II patients on EIACs and >2 prior regimens	Phase II patients not on EIACs and >2 prior regimens
Measure Participants	12	0	39	0	12
Number [percentage of patients]	33.35	33.3	25

2. Secondary Outcome

Title	Confirmed Response (i.e., an Objective Status of Complete Response (CR), Partial Response (PR), or Regression (REGR) on 2 Successive Evaluations at Least 4 Weeks Apart After the Start of Study Treatment).
Description	Complete Response (CR) is defined using response criteria (the neurologic examination and the Magnetic resonance imaging (MRI) and/or Computerized Tomography (CT)), total disappearance of all tumor with patient off corticosteroids or only on adrenal replacement maintenance. Partial Response (PR) is defined using response criteria (the neurologic examination and the MRI and/or CT), >=50% reduction in product of perpendicular diameters of contrast enhancement or mass with no new lesions with the patient being on stable or decreased steroid dose. Regression (REGR) is defined using response criteria (the neurologic examination and the MRI and/or CT), unequivocal reduction in size of contrast-enhancement or decrease in mass effect as agreed upon independently by primary physician and quality control physicians; no new lesions. Patient should be on stable or decreased steroid dose.
Time Frame	Up to 5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Study 1 Arm C	Study 2 Arm A	Study 2 Arm B	Study 3 Arm D	Study 3 Arm E
Arm/Group Description	Phase I patients on EIACs and <=2 prior regimens	Phase II patients on EIACs and <=2 prior regimens	Phase II patients not on EIACs and <=2 prior regimens	Phase II patients on EIACs and >2 prior regimens	Phase II patients not on EIACs and >2 prior regimens
Measure Participants	12	0	39	0	12
Number [percentage of confirmed responses]	0	5.1	0

3. Secondary Outcome

Title	Percentage of Patients Progression-free
Description	The percentage of patient progression-free at 12 months, 18 months, and PFS will be estimated. Kaplan-Meier survival curves and logrank tests will be used to estimate progression-time distributions. Progression is defined using response criteria (the neurologic examination and the MRI and/or CT), >25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions.
Time Frame	Time from study registration to date of disease progression or last follow-up, assessed up to 5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Study 1 Arm C	Study 2 Arm A	Study 2 Arm B	Study 3 Arm D	Study 3 Arm E
Arm/Group Description	Phase I patients on EIACs and <=2 prior regimens	Phase II patients on EIACs and <=2 prior regimens	Phase II patients not on EIACs and <=2 prior regimens	Phase II patients on EIACs and >2 prior regimens	Phase II patients not on EIACs and >2 prior regimens
Measure Participants	12	0	39	0	12
Mean (95% Confidence Interval) [months]	1.9	4.0	4.5

4. Secondary Outcome

Title	Overall Time to Death
Description	Kaplan-Meier survival curves and logrank tests will be used to estimate survival distributions.
Time Frame	Time from date of registration to date of death due to any cause or last follow-up, assessed up to 5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Study 1 Arm C	Study 2 Arm A	Study 2 Arm B	Study 3 Arm D	Study 3 Arm E
Arm/Group Description	Phase I patients on EIACs and <=2 prior regimens	Phase II patients on EIACs and <=2 prior regimens	Phase II patients not on EIACs and <=2 prior regimens	Phase II patients on EIACs and >2 prior regimens	Phase II patients not on EIACs and >2 prior regimens
Measure Participants	12	0	39	0	12
Median (95% Confidence Interval) [months]	14.2	16.6	13.6

Adverse Events

Arm/Group Title	Study 2 Arm A		Study 2 Arm B		Study 1 Arm C		Study 3 Arm D		Study 3 Arm E
Arm/Group Description	Phase II patients on EIACs and <=2 prior regimens		Phase II patients not on EIACs and <=2 prior regimens		Phase I patients on EIACs and <=2 prior regimens		Phase II patients on EIACs and >2 prior regimens		Phase II patients not on EIACs and >2 prior regimens
All Cause Mortality
	Study 2 Arm A		Study 2 Arm B		Study 1 Arm C		Study 3 Arm D		Study 3 Arm E
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Study 2 Arm A		Study 2 Arm B		Study 1 Arm C		Study 3 Arm D		Study 3 Arm E
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		12/39 (30.8%)		2/12 (16.7%)		0/0 (NaN)		3/12 (25%)
Blood and lymphatic system disorders
Disseminated intravascular coagulation	0/0 (NaN)	0	1/39 (2.6%)	1	0/12 (0%)	0	0/0 (NaN)	0	0/12 (0%)	0
Febrile neutropenia	0/0 (NaN)	0	1/39 (2.6%)	1	0/12 (0%)	0	0/0 (NaN)	0	0/12 (0%)	0
Cardiac disorders
Edema	0/0 (NaN)	0	1/39 (2.6%)	1	0/12 (0%)	0	0/0 (NaN)	0	0/12 (0%)	0
Ear and labyrinth disorders
Hearing impaired	0/0 (NaN)	0	0/39 (0%)	0	1/12 (8.3%)	1	0/0 (NaN)	0	0/12 (0%)	0
Eye disorders
Vision blurred	0/0 (NaN)	0	0/39 (0%)	0	1/12 (8.3%)	1	0/0 (NaN)	0	0/12 (0%)	0
Gastrointestinal disorders
Gastritis	0/0 (NaN)	0	1/39 (2.6%)	1	0/12 (0%)	0	0/0 (NaN)	0	0/12 (0%)	0
Mucositis oral	0/0 (NaN)	0	1/39 (2.6%)	1	0/12 (0%)	0	0/0 (NaN)	0	0/12 (0%)	0
Nausea	0/0 (NaN)	0	1/39 (2.6%)	1	1/12 (8.3%)	1	0/0 (NaN)	0	1/12 (8.3%)	2
Vomiting	0/0 (NaN)	0	2/39 (5.1%)	2	1/12 (8.3%)	1	0/0 (NaN)	0	1/12 (8.3%)	2
General disorders
Fatigue	0/0 (NaN)	0	2/39 (5.1%)	2	0/12 (0%)	0	0/0 (NaN)	0	2/12 (16.7%)	2
General symptom	0/0 (NaN)	0	1/39 (2.6%)	1	0/12 (0%)	0	0/0 (NaN)	0	0/12 (0%)	0
Infections and infestations
Infection without neutropenia	0/0 (NaN)	0	1/39 (2.6%)	1	0/12 (0%)	0	0/0 (NaN)	0	0/12 (0%)	0
Investigations
Leukocyte count decreased	0/0 (NaN)	0	2/39 (5.1%)	2	0/12 (0%)	0	0/0 (NaN)	0	0/12 (0%)	0
Lymphocyte count decreased	0/0 (NaN)	0	2/39 (5.1%)	2	0/12 (0%)	0	0/0 (NaN)	0	0/12 (0%)	0
Neutrophil count decreased	0/0 (NaN)	0	2/39 (5.1%)	2	0/12 (0%)	0	0/0 (NaN)	0	0/12 (0%)	0
Platelet count decreased	0/0 (NaN)	0	2/39 (5.1%)	2	0/12 (0%)	0	0/0 (NaN)	0	1/12 (8.3%)	1
Metabolism and nutrition disorders
Anorexia	0/0 (NaN)	0	1/39 (2.6%)	1	0/12 (0%)	0	0/0 (NaN)	0	0/12 (0%)	0
Blood glucose increased	0/0 (NaN)	0	2/39 (5.1%)	3	0/12 (0%)	0	0/0 (NaN)	0	1/12 (8.3%)	1
Blood uric acid increased	0/0 (NaN)	0	1/39 (2.6%)	1	0/12 (0%)	0	0/0 (NaN)	0	0/12 (0%)	0
Dehydration	0/0 (NaN)	0	2/39 (5.1%)	2	0/12 (0%)	0	0/0 (NaN)	0	1/12 (8.3%)	1
Serum albumin decreased	0/0 (NaN)	0	1/39 (2.6%)	1	0/12 (0%)	0	0/0 (NaN)	0	0/12 (0%)	0
Serum calcium decreased	0/0 (NaN)	0	0/39 (0%)	0	0/12 (0%)	0	0/0 (NaN)	0	1/12 (8.3%)	1
Serum potassium decreased	0/0 (NaN)	0	0/39 (0%)	0	0/12 (0%)	0	0/0 (NaN)	0	1/12 (8.3%)	1
Serum sodium decreased	0/0 (NaN)	0	1/39 (2.6%)	1	0/12 (0%)	0	0/0 (NaN)	0	0/12 (0%)	0
Serum sodium increased	0/0 (NaN)	0	0/39 (0%)	0	0/12 (0%)	0	0/0 (NaN)	0	1/12 (8.3%)	1
Musculoskeletal and connective tissue disorders
Muscle weakness	0/0 (NaN)	0	0/39 (0%)	0	0/12 (0%)	0	0/0 (NaN)	0	1/12 (8.3%)	1
Nervous system disorders
Depressed level of consciousness	0/0 (NaN)	0	1/39 (2.6%)	1	0/12 (0%)	0	0/0 (NaN)	0	0/12 (0%)	0
Dizziness	0/0 (NaN)	0	0/39 (0%)	0	0/12 (0%)	0	0/0 (NaN)	0	1/12 (8.3%)	1
Headache	0/0 (NaN)	0	1/39 (2.6%)	1	0/12 (0%)	0	0/0 (NaN)	0	1/12 (8.3%)	1
Peripheral motor neuropathy	0/0 (NaN)	0	3/39 (7.7%)	3	0/12 (0%)	0	0/0 (NaN)	0	1/12 (8.3%)	1
Seizure	0/0 (NaN)	0	5/39 (12.8%)	6	0/12 (0%)	0	0/0 (NaN)	0	1/12 (8.3%)	1
Speech disorder	0/0 (NaN)	0	1/39 (2.6%)	1	0/12 (0%)	0	0/0 (NaN)	0	0/12 (0%)	0
Psychiatric disorders
Confusion	0/0 (NaN)	0	0/39 (0%)	0	0/12 (0%)	0	0/0 (NaN)	0	1/12 (8.3%)	1
Depression	0/0 (NaN)	0	1/39 (2.6%)	1	0/12 (0%)	0	0/0 (NaN)	0	1/12 (8.3%)	2
Personality change	0/0 (NaN)	0	1/39 (2.6%)	1	0/12 (0%)	0	0/0 (NaN)	0	0/12 (0%)	0
Renal and urinary disorders
Proteinuria	0/0 (NaN)	0	1/39 (2.6%)	1	0/12 (0%)	0	0/0 (NaN)	0	0/12 (0%)	0
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)	0/0 (NaN)	0	2/39 (5.1%)	2	0/12 (0%)	0	0/0 (NaN)	0	0/12 (0%)	0
Hiccups	0/0 (NaN)	0	0/39 (0%)	0	0/12 (0%)	0	0/0 (NaN)	0	1/12 (8.3%)	1
Pleural effusion	0/0 (NaN)	0	1/39 (2.6%)	1	0/12 (0%)	0	0/0 (NaN)	0	0/12 (0%)	0
Pneumonitis	0/0 (NaN)	0	2/39 (5.1%)	2	0/12 (0%)	0	0/0 (NaN)	0	0/12 (0%)	0
Skin and subcutaneous tissue disorders
Petechiae	0/0 (NaN)	0	1/39 (2.6%)	1	0/12 (0%)	0	0/0 (NaN)	0	0/12 (0%)	0
Vascular disorders
Hemorrhage	0/0 (NaN)	0	3/39 (7.7%)	3	0/12 (0%)	0	0/0 (NaN)	0	0/12 (0%)	0
Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia	0/0 (NaN)	0	1/39 (2.6%)	1	0/12 (0%)	0	0/0 (NaN)	0	0/12 (0%)	0
Hypotension	0/0 (NaN)	0	1/39 (2.6%)	1	0/12 (0%)	0	0/0 (NaN)	0	1/12 (8.3%)	1
Thrombosis	0/0 (NaN)	0	2/39 (5.1%)	2	0/12 (0%)	0	0/0 (NaN)	0	0/12 (0%)	0
Other (Not Including Serious) Adverse Events
	Study 2 Arm A		Study 2 Arm B		Study 1 Arm C		Study 3 Arm D		Study 3 Arm E
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		37/39 (94.9%)		12/12 (100%)		0/0 (NaN)		11/12 (91.7%)
Blood and lymphatic system disorders
Hemoglobin decreased	0/0 (NaN)	0	13/39 (33.3%)	82	4/12 (33.3%)	19	0/0 (NaN)	0	2/12 (16.7%)	29
Hemoglobin for leukemia studies	0/0 (NaN)	0	2/39 (5.1%)	6	1/12 (8.3%)	1	0/0 (NaN)	0	1/12 (8.3%)	1
Hemolysis	0/0 (NaN)	0	1/39 (2.6%)	1	0/12 (0%)	0	0/0 (NaN)	0	0/12 (0%)	0
Cardiac disorders
Edema	0/0 (NaN)	0	16/39 (41%)	84	2/12 (16.7%)	8	0/0 (NaN)	0	2/12 (16.7%)	11
Sinus tachycardia	0/0 (NaN)	0	1/39 (2.6%)	1	0/12 (0%)	0	0/0 (NaN)	0	0/12 (0%)	0
Ear and labyrinth disorders
Ear disorder	0/0 (NaN)	0	1/39 (2.6%)	1	0/12 (0%)	0	0/0 (NaN)	0	0/12 (0%)	0
Hearing impaired	0/0 (NaN)	0	1/39 (2.6%)	1	0/12 (0%)	0	0/0 (NaN)	0	0/12 (0%)	0
Endocrine disorders
Cushingoid	0/0 (NaN)	0	2/39 (5.1%)	3	0/12 (0%)	0	0/0 (NaN)	0	0/12 (0%)	0
Eye disorders
Eye disorder	0/0 (NaN)	0	3/39 (7.7%)	3	1/12 (8.3%)	2	0/0 (NaN)	0	0/12 (0%)	0
Photophobia	0/0 (NaN)	0	0/39 (0%)	0	1/12 (8.3%)	1	0/0 (NaN)	0	0/12 (0%)	0
Vision blurred	0/0 (NaN)	0	1/39 (2.6%)	1	0/12 (0%)	0	0/0 (NaN)	0	0/12 (0%)	0
Watering eyes	0/0 (NaN)	0	1/39 (2.6%)	1	0/12 (0%)	0	0/0 (NaN)	0	0/12 (0%)	0
Gastrointestinal disorders
Abdominal pain	0/0 (NaN)	0	3/39 (7.7%)	4	1/12 (8.3%)	2	0/0 (NaN)	0	0/12 (0%)	0
Constipation	0/0 (NaN)	0	3/39 (7.7%)	6	1/12 (8.3%)	3	0/0 (NaN)	0	0/12 (0%)	0
Diarrhea	0/0 (NaN)	0	18/39 (46.2%)	53	3/12 (25%)	14	0/0 (NaN)	0	4/12 (33.3%)	13
Diarrhea patients with a colostomy	0/0 (NaN)	0	2/39 (5.1%)	2	0/12 (0%)	0	0/0 (NaN)	0	0/12 (0%)	0
Dry mouth	0/0 (NaN)	0	1/39 (2.6%)	35	0/12 (0%)	0	0/0 (NaN)	0	0/12 (0%)	0
Dyspepsia	0/0 (NaN)	0	6/39 (15.4%)	18	1/12 (8.3%)	1	0/0 (NaN)	0	0/12 (0%)	0
Esophagitis	0/0 (NaN)	0	1/39 (2.6%)	1	0/12 (0%)	0	0/0 (NaN)	0	0/12 (0%)	0
Flatulence	0/0 (NaN)	0	1/39 (2.6%)	1	0/12 (0%)	0	0/0 (NaN)	0	0/12 (0%)	0
Mucositis oral	0/0 (NaN)	0	7/39 (17.9%)	10	1/12 (8.3%)	1	0/0 (NaN)	0	1/12 (8.3%)	1
Nausea	0/0 (NaN)	0	15/39 (38.5%)	77	6/12 (50%)	21	0/0 (NaN)	0	3/12 (25%)	7
Vomiting	0/0 (NaN)	0	10/39 (25.6%)	16	3/12 (25%)	5	0/0 (NaN)	0	0/12 (0%)	0
General disorders
Chills	0/0 (NaN)	0	0/39 (0%)	0	1/12 (8.3%)	5	0/0 (NaN)	0	0/12 (0%)	0
Fatigue	0/0 (NaN)	0	27/39 (69.2%)	211	6/12 (50%)	29	0/0 (NaN)	0	6/12 (50%)	23
Fever	0/0 (NaN)	0	2/39 (5.1%)	2	0/12 (0%)	0	0/0 (NaN)	0	0/12 (0%)	0
General symptom	0/0 (NaN)	0	1/39 (2.6%)	1	0/12 (0%)	0	0/0 (NaN)	0	0/12 (0%)	0
Pain	0/0 (NaN)	0	2/39 (5.1%)	2	1/12 (8.3%)	4	0/0 (NaN)	0	0/12 (0%)	0
Immune system disorders
Hypersensitivity	0/0 (NaN)	0	1/39 (2.6%)	1	0/12 (0%)	0	0/0 (NaN)	0	0/12 (0%)	0
Infections and infestations
Infection	0/0 (NaN)	0	1/39 (2.6%)	1	0/12 (0%)	0	0/0 (NaN)	0	0/12 (0%)	0
Infection without neutropenia	0/0 (NaN)	0	7/39 (17.9%)	10	1/12 (8.3%)	1	0/0 (NaN)	0	0/12 (0%)	0
Wound-infectious	0/0 (NaN)	0	1/39 (2.6%)	1	0/12 (0%)	0	0/0 (NaN)	0	0/12 (0%)	0
Injury, poisoning and procedural complications
Bruising	0/0 (NaN)	0	1/39 (2.6%)	2	0/12 (0%)	0	0/0 (NaN)	0	0/12 (0%)	0
Investigations
Alanine aminotransferase increased	0/0 (NaN)	0	3/39 (7.7%)	6	0/12 (0%)	0	0/0 (NaN)	0	0/12 (0%)	0
Alkaline phosphatase	0/0 (NaN)	0	3/39 (7.7%)	8	4/12 (33.3%)	15	0/0 (NaN)	0	0/12 (0%)	0
Aspartate aminotransferase increased	0/0 (NaN)	0	13/39 (33.3%)	34	5/12 (41.7%)	8	0/0 (NaN)	0	1/12 (8.3%)	1
Blood bilirubin increased	0/0 (NaN)	0	3/39 (7.7%)	3	0/12 (0%)	0	0/0 (NaN)	0	0/12 (0%)	0
Creatinine increased	0/0 (NaN)	0	6/39 (15.4%)	16	0/12 (0%)	0	0/0 (NaN)	0	0/12 (0%)	0
Laboratory test abnormal	0/0 (NaN)	0	3/39 (7.7%)	4	1/12 (8.3%)	2	0/0 (NaN)	0	0/12 (0%)	0
Leukocyte count decreased	0/0 (NaN)	0	17/39 (43.6%)	103	4/12 (33.3%)	13	0/0 (NaN)	0	3/12 (25%)	4
Leukocytes for pediatric BMT studies	0/0 (NaN)	0	0/39 (0%)	0	1/12 (8.3%)	1	0/0 (NaN)	0	0/12 (0%)	0
Lymphocyte count decreased	0/0 (NaN)	0	0/39 (0%)	0	1/12 (8.3%)	1	0/0 (NaN)	0	2/12 (16.7%)	21
Neutrophil count decreased	0/0 (NaN)	0	17/39 (43.6%)	84	4/12 (33.3%)	13	0/0 (NaN)	0	3/12 (25%)	3
Platelet count decreased	0/0 (NaN)	0	15/39 (38.5%)	97	4/12 (33.3%)	12	0/0 (NaN)	0	3/12 (25%)	5
Weight gain	0/0 (NaN)	0	1/39 (2.6%)	1	0/12 (0%)	0	0/0 (NaN)	0	0/12 (0%)	0
Weight loss	0/0 (NaN)	0	3/39 (7.7%)	14	0/12 (0%)	0	0/0 (NaN)	0	0/12 (0%)	0
Metabolism and nutrition disorders
Anorexia	0/0 (NaN)	0	6/39 (15.4%)	12	1/12 (8.3%)	1	0/0 (NaN)	0	1/12 (8.3%)	2
Blood glucose increased	0/0 (NaN)	0	18/39 (46.2%)	45	8/12 (66.7%)	15	0/0 (NaN)	0	4/12 (33.3%)	31
Serum albumin decreased	0/0 (NaN)	0	3/39 (7.7%)	6	0/12 (0%)	0	0/0 (NaN)	0	0/12 (0%)	0
Serum calcium decreased	0/0 (NaN)	0	7/39 (17.9%)	19	2/12 (16.7%)	4	0/0 (NaN)	0	2/12 (16.7%)	2
Serum glucose decreased	0/0 (NaN)	0	1/39 (2.6%)	3	0/12 (0%)	0	0/0 (NaN)	0	0/12 (0%)	0
Serum magnesium decreased	0/0 (NaN)	0	1/39 (2.6%)	4	1/12 (8.3%)	1	0/0 (NaN)	0	0/12 (0%)	0
Serum magnesium increased	0/0 (NaN)	0	1/39 (2.6%)	1	1/12 (8.3%)	1	0/0 (NaN)	0	0/12 (0%)	0
Serum phosphate decreased	0/0 (NaN)	0	10/39 (25.6%)	130	4/12 (33.3%)	11	0/0 (NaN)	0	2/12 (16.7%)	3
Serum potassium decreased	0/0 (NaN)	0	4/39 (10.3%)	18	0/12 (0%)	0	0/0 (NaN)	0	0/12 (0%)	0
Serum potassium increased	0/0 (NaN)	0	1/39 (2.6%)	1	0/12 (0%)	0	0/0 (NaN)	0	0/12 (0%)	0
Serum sodium decreased	0/0 (NaN)	0	4/39 (10.3%)	5	0/12 (0%)	0	0/0 (NaN)	0	1/12 (8.3%)	1
Musculoskeletal and connective tissue disorders
Arthralgia	0/0 (NaN)	0	0/39 (0%)	0	0/12 (0%)	0	0/0 (NaN)	0	1/12 (8.3%)	1
Bone pain	0/0 (NaN)	0	1/39 (2.6%)	1	0/12 (0%)	0	0/0 (NaN)	0	0/12 (0%)	0
Muscle weakness	0/0 (NaN)	0	2/39 (5.1%)	3	0/12 (0%)	0	0/0 (NaN)	0	0/12 (0%)	0
Musculoskeletal disorder	0/0 (NaN)	0	1/39 (2.6%)	1	0/12 (0%)	0	0/0 (NaN)	0	0/12 (0%)	0
Myalgia	0/0 (NaN)	0	4/39 (10.3%)	16	0/12 (0%)	0	0/0 (NaN)	0	0/12 (0%)	0
Nervous system disorders
Ataxia	0/0 (NaN)	0	1/39 (2.6%)	1	2/12 (16.7%)	3	0/0 (NaN)	0	0/12 (0%)	0
Cognitive disturbance/learning problems (for pediatrics)	0/0 (NaN)	0	1/39 (2.6%)	1	0/12 (0%)	0	0/0 (NaN)	0	0/12 (0%)	0
Depressed level of consciousness	0/0 (NaN)	0	3/39 (7.7%)	30	2/12 (16.7%)	7	0/0 (NaN)	0	1/12 (8.3%)	1
Dizziness	0/0 (NaN)	0	0/39 (0%)	0	2/12 (16.7%)	3	0/0 (NaN)	0	0/12 (0%)	0
Dysgeusia	0/0 (NaN)	0	1/39 (2.6%)	3	0/12 (0%)	0	0/0 (NaN)	0	0/12 (0%)	0
Headache	0/0 (NaN)	0	4/39 (10.3%)	13	2/12 (16.7%)	9	0/0 (NaN)	0	0/12 (0%)	0
Memory impairment	0/0 (NaN)	0	3/39 (7.7%)	5	0/12 (0%)	0	0/0 (NaN)	0	0/12 (0%)	0
Neurological disorder NOS	0/0 (NaN)	0	2/39 (5.1%)	9	1/12 (8.3%)	4	0/0 (NaN)	0	0/12 (0%)	0
Neuropathy - cranial	0/0 (NaN)	0	0/39 (0%)	0	1/12 (8.3%)	1	0/0 (NaN)	0	0/12 (0%)	0
Peripheral motor neuropathy	0/0 (NaN)	0	9/39 (23.1%)	28	4/12 (33.3%)	9	0/0 (NaN)	0	8/12 (66.7%)	23
Peripheral sensory neuropathy	0/0 (NaN)	0	12/39 (30.8%)	31	3/12 (25%)	8	0/0 (NaN)	0	3/12 (25%)	21
Seizure	0/0 (NaN)	0	2/39 (5.1%)	11	0/12 (0%)	0	0/0 (NaN)	0	0/12 (0%)	0
Speech disorder	0/0 (NaN)	0	1/39 (2.6%)	1	1/12 (8.3%)	1	0/0 (NaN)	0	0/12 (0%)	0
Psychiatric disorders
Confusion	0/0 (NaN)	0	2/39 (5.1%)	2	0/12 (0%)	0	0/0 (NaN)	0	0/12 (0%)	0
Depression	0/0 (NaN)	0	2/39 (5.1%)	2	1/12 (8.3%)	3	0/0 (NaN)	0	0/12 (0%)	0
Insomnia	0/0 (NaN)	0	6/39 (15.4%)	18	0/12 (0%)	0	0/0 (NaN)	0	0/12 (0%)	0
Personality change	0/0 (NaN)	0	0/39 (0%)	0	1/12 (8.3%)	2	0/0 (NaN)	0	0/12 (0%)	0
Renal and urinary disorders
Incontinence	0/0 (NaN)	0	1/39 (2.6%)	1	0/12 (0%)	0	0/0 (NaN)	0	0/12 (0%)	0
Urinary frequency	0/0 (NaN)	0	2/39 (5.1%)	8	0/12 (0%)	0	0/0 (NaN)	0	0/12 (0%)	0
Reproductive system and breast disorders
Irregular menstruation	0/0 (NaN)	0	0/39 (0%)	0	0/12 (0%)	0	0/0 (NaN)	0	1/12 (8.3%)	2
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis	0/0 (NaN)	0	3/39 (7.7%)	8	0/12 (0%)	0	0/0 (NaN)	0	0/12 (0%)	0
Cough	0/0 (NaN)	0	4/39 (10.3%)	9	1/12 (8.3%)	1	0/0 (NaN)	0	0/12 (0%)	0
Dyspnea (shortness of breath)	0/0 (NaN)	0	1/39 (2.6%)	4	0/12 (0%)	0	0/0 (NaN)	0	0/12 (0%)	0
Skin and subcutaneous tissue disorders
Alopecia	0/0 (NaN)	0	2/39 (5.1%)	20	0/12 (0%)	0	0/0 (NaN)	0	1/12 (8.3%)	6
Dry skin	0/0 (NaN)	0	2/39 (5.1%)	4	1/12 (8.3%)	1	0/0 (NaN)	0	0/12 (0%)	0
Nail disorder	0/0 (NaN)	0	2/39 (5.1%)	25	0/12 (0%)	0	0/0 (NaN)	0	0/12 (0%)	0
Pruritus	0/0 (NaN)	0	1/39 (2.6%)	3	1/12 (8.3%)	1	0/0 (NaN)	0	0/12 (0%)	0
Rash desquamating	0/0 (NaN)	0	12/39 (30.8%)	32	0/12 (0%)	0	0/0 (NaN)	0	2/12 (16.7%)	3
Skin disorder	0/0 (NaN)	0	0/39 (0%)	0	1/12 (8.3%)	1	0/0 (NaN)	0	0/12 (0%)	0
Sweating	0/0 (NaN)	0	1/39 (2.6%)	1	0/12 (0%)	0	0/0 (NaN)	0	0/12 (0%)	0
Vascular disorders
Flushing	0/0 (NaN)	0	3/39 (7.7%)	3	0/12 (0%)	0	0/0 (NaN)	0	0/12 (0%)	0
Hemorrhage	0/0 (NaN)	0	4/39 (10.3%)	18	2/12 (16.7%)	2	0/0 (NaN)	0	0/12 (0%)	0
Thrombosis	0/0 (NaN)	0	1/39 (2.6%)	1	0/12 (0%)	0	0/0 (NaN)	0	0/12 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.