Interleukin-2 in Treating Children Who Have Undergone Bone Marrow Transplantation for Acute Myeloid Leukemia

Sponsor

Children's Oncology Group (Other)

Overall Status

Completed

CT.gov ID

NCT00009698

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

119

Locations

Arm

90.1

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill more cancer cells.

PURPOSE: Phase I trial to study the effectiveness of interleukin-2 in treating children who have undergone bone marrow transplantation for acute myeloid leukemia.

Condition or Disease	Intervention/Treatment	Phase
Leukemia	Biological: aldesleukin	Phase 1

Detailed Description

OBJECTIVES: I. Determine the maximum tolerated dose of interleukin-2 after autologous bone marrow transplantation in pediatric patients with acute myeloid leukemia. II. Determine toxic effects of this regimen in these patients.

OUTLINE: This is a dose escalation study. Patients receive interleukin-2 (IL-2) subcutaneously on days 1-7, 9-14, and 16-22. On days 8 and 15, patients receive IL-2 IV over 2 hours. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 6-9 patients receive escalating doses of IL-2 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 or 2 of 9 patients experience dose-limiting toxicity. Patients are followed every 6 months for 4 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 6-27 patients will be accrued for this study.

Study Design

Study Type:

Interventional

Actual Enrollment :

1 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

IL-2 Infusion in AML Patients After Autologous Bone Marrow Transplant: A Pediatric Oncology Group Wide Phase I Trial

Study Start Date :

Mar 1, 1998

Actual Primary Completion Date :

Jun 1, 2001

Actual Study Completion Date :

Sep 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Experimental: All patients Day 1 through day 7, days 9-14 and days 16-22: The assigned dose of IL-2 will be administered SQ. On days 8 and 15, IL-2 will be administered as a 2 hour intravenous infusion of one million units/M2 of IL-2. After day 22 there will be a 7 day rest period before beginning the next cycle. The next cycle will repeat just as above. This will be repeated for a maximum of 4 total cycles of 21 days of IL-2 therapy. The maintenance dose of IL-2 will always be the same as given during cycle one, unless there is dose limiting toxicity.	Biological: aldesleukin Given SQ and IV Other Names: Recombinant Interleukin-2 (Chiron-Cetus) (IL-2) NSC -373364

Arm

Intervention/Treatment

Experimental: All patients

Day 1 through day 7, days 9-14 and days 16-22: The assigned dose of IL-2 will be administered SQ. On days 8 and 15, IL-2 will be administered as a 2 hour intravenous infusion of one million units/M2 of IL-2. After day 22 there will be a 7 day rest period before beginning the next cycle. The next cycle will repeat just as above. This will be repeated for a maximum of 4 total cycles of 21 days of IL-2 therapy. The maintenance dose of IL-2 will always be the same as given during cycle one, unless there is dose limiting toxicity.

Biological: aldesleukin

Given SQ and IV

Other Names:

Recombinant Interleukin-2 (Chiron-Cetus) (IL-2)

NSC -373364

Outcome Measures

Primary Outcome Measures

To determine the maximum tolerated dose (MTD) of IL-2 [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 21 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS: Diagnosis of acute myeloid leukemia (AML) Must have received autologous bone marrow or stem cell transplantation for AML within the past 28 to 100 days Evidence of marrow engraftment Absolute neutrophil count at least 500/mm3 for at least 2 consecutive days Platelet count at least 20,000/mm3 without transfusion support for more than 3 days Documented M1 or M2 bone marrow within the past 7 days

PATIENT CHARACTERISTICS: Age: Under 22 at diagnosis Performance status: Karnofsky 50-100%

Life expectancy: At least 8 weeks Hematopoietic: See Disease Characteristics Hepatic:

Bilirubin no greater than 1.5 mg/dL SGPT no greater than 2 times normal Renal: Creatinine normal OR Glomerular filtration rate at least 70 mL/min Cardiovascular: Shortening fraction at least 27% OR Ejection fraction greater than 50% No evidence of active cardiac disease by electrocardiogram Pulmonary: No evidence of active pulmonary disease by chest x-ray Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Neurologic deficits due to CNS disease must be stable within the past 4 weeks No active viral, bacterial, or invasive fungal infection No fever No prior hypersensitivity to interleukin-2 No greater than grade 2 mucosal toxicity

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics At least 3 days since prior growth factors or intravenous immunoglobulin No concurrent cytokines or growth factors No concurrent intravenous immunoglobulin Chemotherapy: No concurrent chemotherapy No concurrent methotrexate IV or intrathecally Endocrine therapy: At least 3 days since prior corticosteroids No concurrent corticosteroids (except as premedication for documented severe transfusion reactions) Radiotherapy: Not specified Surgery: Not specified Other: At least 3 days since prior pentoxifylline or amphotericin B No concurrent pentoxifylline No other concurrent anticancer therapy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham Comprehensive Cancer Center	Birmingham	Alabama	United States	35294-3300
2	University of South Alabama Medical Center	Mobile	Alabama	United States	36617-2293
3	MBCCOP - Gulf Coast	Mobile	Alabama	United States	36688
4	Arizona Cancer Center	Tucson	Arizona	United States	85724
5	Arkansas Children's Hospital	Little Rock	Arkansas	United States	72202-3591
6	University of Arkansas for Medical Sciences	Little Rock	Arkansas	United States	72205
7	University of California San Diego Cancer Center	La Jolla	California	United States	92093-0658
8	Lucile Packard Children's Hospital at Stanford	Palo Alto	California	United States	94304
9	Sutter Cancer Center	Sacramento	California	United States	95816
10	University of California Davis Medical Center	Sacramento	California	United States	95817
11	Kaiser Permanente-Southern California Permanente Medical Group	San Diego	California	United States	92120
12	Children's Hospital and Health Center	San Diego	California	United States	92123-4282
13	Kaiser Permanente Medical Center - Santa Clara	Santa Clara	California	United States	95051-5386
14	Yale Comprehensive Cancer Center	New Haven	Connecticut	United States	06520-8028
15	Walter Reed Army Medical Center	Washington	District of Columbia	United States	20307-5000
16	Broward General Medical Center	Fort Lauderdale	Florida	United States	33316
17	Children's Hospital of Southwest Florida	Fort Myers	Florida	United States	33908
18	Shands Hospital and Clinics, University of Florida	Gainesville	Florida	United States	32610-100277
19	Nemours Children's Clinic	Jacksonville	Florida	United States	32207
20	Sylvester Cancer Center, University of Miami	Miami	Florida	United States	33136
21	University of Miami-Jackson Memorial Hospital Medical Center	Miami	Florida	United States	33136
22	Miami Children's Hospital	Miami	Florida	United States	33155
23	Baptist Hospital of Miami	Miami	Florida	United States	33176-2197
24	Walt Disney Memorial Cancer Institute	Orlando	Florida	United States	32803
25	All Children's Hospital	St. Petersburg	Florida	United States	33701
26	CCOP - Florida Pediatric	Tampa	Florida	United States	33682-7757
27	St. Mary's Hospital	West Palm Beach	Florida	United States	33407
28	Emory University Hospital - Atlanta	Atlanta	Georgia	United States	30322
29	Cancer Research Center of Hawaii	Honolulu	Hawaii	United States	96813
30	Tripler Army Medical Center	Honolulu	Hawaii	United States	96859-5000
31	Rush-Presbyterian-St. Luke's Medical Center	Chicago	Illinois	United States	60612
32	Children's Memorial Hospital, Chicago	Chicago	Illinois	United States	60614
33	Hope Children's Hospital	Oak Lawn	Illinois	United States	60453
34	CCOP - Illinois Oncology Research Association	Peoria	Illinois	United States	61602
35	Saint Jude Midwest Affiliate	Peoria	Illinois	United States	61637
36	University of Kansas Medical Center	Kansas City	Kansas	United States	66160-7357
37	CCOP - Wichita	Wichita	Kansas	United States	67214-3882
38	Via Christi Regional Medical Center	Wichita	Kansas	United States	67214
39	MBCCOP - LSU Health Sciences Center	New Orleans	Louisiana	United States	70112
40	Tulane University School of Medicine	New Orleans	Louisiana	United States	70112
41	CCOP - Ochsner	New Orleans	Louisiana	United States	70121
42	Eastern Maine Medical Center	Bangor	Maine	United States	04401
43	Maine Children's Cancer Program	Portland	Maine	United States	04101
44	Marlene & Stewart Greenebaum Cancer Center, University of Maryland	Baltimore	Maryland	United States	21201
45	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland	United States	21231-2410
46	Boston Floating Hospital Infants and Children	Boston	Massachusetts	United States	02111
47	Massachusetts General Hospital Cancer Center	Boston	Massachusetts	United States	02114
48	Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02115
49	University of Massachusetts Memorial Medical Center	Worcester	Massachusetts	United States	01655
50	Children's Hospital of Michigan	Detroit	Michigan	United States	48201
51	St. John's Hospital and Medical Center	Detroit	Michigan	United States	48236
52	Hurley Medical Center	Flint	Michigan	United States	48503
53	University of Mississippi Medical Center	Jackson	Mississippi	United States	39216-4505
54	Keesler Medical Center - Keesler AFB	Keesler AFB	Mississippi	United States	39534-2576
55	University of Missouri-Columbia Hospital and Clinics	Columbia	Missouri	United States	65212
56	Cardinal Glennon Children's Hospital	Saint Louis	Missouri	United States	63104
57	Washington University School of Medicine	Saint Louis	Missouri	United States	63110
58	Norris Cotton Cancer Center	Lebanon	New Hampshire	United States	03756-0002
59	CCOP - Northern New Jersey	Hackensack	New Jersey	United States	07601
60	Hackensack University Medical Center	Hackensack	New Jersey	United States	07601
61	University of New Mexico School of Medicine	Albuquerque	New Mexico	United States	87131
62	Roswell Park Cancer Institute	Buffalo	New York	United States	14263-0001
63	Schneider Children's Hospital	New Hyde Park	New York	United States	11042
64	Mount Sinai School of Medicine	New York	New York	United States	10029
65	University of Rochester Cancer Center	Rochester	New York	United States	14642
66	State University of New York Health Sciences Center - Stony Brook	Stony Brook	New York	United States	11790-7775
67	State University of New York - Upstate Medical University	Syracuse	New York	United States	13210
68	Mission Saint Joseph's Health System	Asheville	North Carolina	United States	28801
69	Carolinas Medical Center	Charlotte	North Carolina	United States	28232-2861
70	Presbyterian Healthcare	Charlotte	North Carolina	United States	28233-3549
71	Duke Comprehensive Cancer Center	Durham	North Carolina	United States	27710
72	East Carolina University School of Medicine	Greenville	North Carolina	United States	27858-4354
73	Comprehensive Cancer Center at Wake Forest University	Winston-Salem	North Carolina	United States	27157-1082
74	Oklahoma Memorial Hospital	Oklahoma City	Oklahoma	United States	73126-0307
75	Natalie Warren Bryant Cancer Center	Tulsa	Oklahoma	United States	74136
76	CCOP - Columbia River Program	Portland	Oregon	United States	97213
77	Legacy Emanuel Hospital and Health Center	Portland	Oregon	United States	97227
78	St. Christopher's Hospital for Children	Philadelphia	Pennsylvania	United States	19134-1095
79	Medical University of South Carolina	Charleston	South Carolina	United States	29425-0721
80	Children's Hospital of Greenville Hospital System	Greenville	South Carolina	United States	29605
81	James H. Quillen College of Medicine	Johnson City	Tennessee	United States	37614-0622
82	Saint Jude Children's Research Hospital	Memphis	Tennessee	United States	38105-2794
83	Driscoll Children's Hospital	Corpus Christi	Texas	United States	78466
84	Texas Oncology P.A.	Dallas	Texas	United States	75230-2503
85	Medical City Dallas Hospital	Dallas	Texas	United States	75230
86	Simmons Cancer Center - Dallas	Dallas	Texas	United States	75235-9154
87	Cook Children's Medical Center - Fort Worth	Fort Worth	Texas	United States	76104
88	University of Texas Medical Branch	Galveston	Texas	United States	77555-0209
89	Baylor College of Medicine	Houston	Texas	United States	77030
90	San Antonio Military Pediatric Cancer and Blood Disorders Center	Lackland Air Force Base	Texas	United States	78236-5300
91	MBCCOP - South Texas Pediatric	San Antonio	Texas	United States	78229-3900
92	University of Texas Health Science Center at San Antonio	San Antonio	Texas	United States	78284-7811
93	Scott and White Clinic	Temple	Texas	United States	76508
94	Vermont Cancer Center	Burlington	Vermont	United States	05401-3498
95	Cancer Center at the University of Virginia	Charlottesville	Virginia	United States	22908
96	Inova Fairfax Hospital	Falls Church	Virginia	United States	22042-3300
97	Naval Medical Center, Portsmouth	Portsmouth	Virginia	United States	23708-2197
98	Massey Cancer Center	Richmond	Virginia	United States	23298-0037
99	Carilion Roanoke Community Hospital	Roanoke	Virginia	United States	24029
100	Madigan Army Medical Center	Tacoma	Washington	United States	98431-5000
101	West Virginia University Medical School-Charleston	Charleston	West Virginia	United States	25304
102	West Virginia University Hospitals	Morgantown	West Virginia	United States	26506-9300
103	St. Vincent Hospital	Green Bay	Wisconsin	United States	54307-3508
104	Midwest Children's Cancer Center	Milwaukee	Wisconsin	United States	53226
105	Royal Children's Hospital	Parkville	Victoria	Australia	3052
106	Alberta Children's Hospital	Calgary	Alberta	Canada	T2T 5C7
107	Cross Cancer Institute	Edmonton	Alberta	Canada	T6G 1Z2
108	Children's Hospital	Hamilton	Ontario	Canada	L8N 3Z5
109	Children's Hospital of Eastern Ontario	Ottawa	Ontario	Canada	K1H 8L1
110	Hospital for Sick Children	Toronto	Ontario	Canada	M5G 1X8
111	McGill University Health Center - Montreal Children's Hospital	Montreal	Quebec	Canada	H3H 1P3
112	Hopital Sainte Justine	Montreal	Quebec	Canada	H3T 1C5
113	Centre Hospitalier de L'Universite Laval	Sainte Foy	Quebec	Canada	GIV 4G2
114	Laval University Medical Center	Sainte-Foy	Quebec	Canada	G1V 4G2
115	Academisch Ziekenhuis Groningen	Groningen		Netherlands	9713 EZ
116	San Jorge Childrens Hospital	Santurce		Puerto Rico	00912
117	Swiss Pediatric Oncology Group Bern	Bern		Switzerland	CH 3010
118	Clinique de Pediatrie	Geneva		Switzerland	1211
119	Centre Hospitalier Universitaire Vaudois	Lausanne		Switzerland	CH-1011