PPX and Concurrent Radiation for Newly Diagnosed Glioblastoma Without MGMT Methylation
Sponsor
Brown University (Other)
Overall Status
Completed
CT.gov ID
NCT01402063
Collaborator
Rhode Island Hospital (Other), Milton S. Hershey Medical Center (Other), University of Washington (Other), University of Massachusetts, Worcester (Other), MaineHealth (Other), University of California, San Diego (Other), Thomas Jefferson University (Other)
63
9
2
45
7
0.2
Study Details
Study Description
Brief Summary
To obtain preliminary data in a randomized phase II study whether PPX/RT improves progression-free survival as compared to temozolomide/RT for patients with GBM without MGMT methylation.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
To evaluate the toxicities of PPX/RT To evaluate neuro-cognitive functional assessments of patients with GBM receiving PPX/RT To obtain preliminary data in a randomized phase II study whether PPX/RT improves overall survival as compared to temozolomide /RT for patients with GBM without MGMT methylation to facilitate planning a phase III study.
Study Design
Study Type:
Interventional
Actual Enrollment
:
63 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
PPX and Concurrent Radiation for Newly Diagnosed Glioblastoma Without MGMT Methylation: A Randomized Phase II Study
Study Start Date
:
Sep 1, 2011
Actual Primary Completion Date
:
Apr 1, 2014
Actual Study Completion Date
:
Jun 1, 2015
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: radiation plus PPX(CT2103 Radiation therapy, Monday through Friday, for 6 weeks for a total of 30 treatments + intravenous PPX every week x 6 weeks for a total of 6 treatments |
Drug: PPX (CT2103)
XRT: 60 Gy at 2 Gy/fraction x 30 fractions PPX: 50 mg/m2/week x 6 weeks during radiation Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum.
|
| Active Comparator: radiation + Temozolomide Radiation therapy, Monday through Friday, for 6 weeks for a total of 30 treatments + Daily oral temozolomide(TMZ) (7 days) x 6 wks for a total of 42 days |
Drug: Temozolomide
XRT: 60 Gy at 2 Gy/fraction x 30 fractions Temozolomide, 75 mg/m2/day, 7 days per week, from the first to the last day of radiotherapy Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum
|
Outcome Measures
Primary Outcome Measures
- Progression Free Survival PPX/RT Versus TMZ/RT for Patients With GBM Without Methylation [Q 3 months on study then Q3 months in f/u for yr 1, q 4 months yr 2, q 6 months for approximately 4 ys.]
MRI response evaluated by RANO criteria Complete Response (CR): Circumstance when the enhancing tumor is no longer seen by neuroimaging, with the patient off all steroids or on adrenal maintenance only; CR will be coded only if confirmed by a second CT/MR scan performed a minimum of 4 weeks after the initial scan coding a response. Partial Response (PR): Decrease of > 50% in the product of two diameters. Patients should be receiving stable or decreasing doses of steroids. PR will be coded only if confirmed by a second CT/MR scan performed a minimum of 4 weeks after the initial scan. Progression (P): A > 25% increase in tumor area (two diameters) provided that the patient has not had his/her dose of steroids decreased since the last evaluation period. This will not need a confirmatory scan. A concomitant decrease in steroid dose will rule out a progression designation during the first 2 months after completion of XRT.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Histologically proven diagnosis of glioblastoma or gliosarcoma (WHO grade IV)
-
GBM must have unmethylated MGMT as determined by central laboratory
-
Diagnosis of GBM must be made by biopsy or surgical excision, either partial or complete; as long as there is sufficient tissue to determine MGMT status
-
No prior chemotherapy or radiation for brain tumor
-
Must be able to tolerate brain MRIs.
*A diagnostic contrast-enhanced MRI must be performed postoperatively within 42 days prior to study registration.
-
KPS >60.
-
Age > 18
-
Life expectancy of at least 3 months.
-
Absolute neutrophil count > 1500/mm3, Platelets > 100,000/mm,
-
Creatinine < 2 x ULN
-
ALT or AST < 3 x upper limit of normal (ULN) and total bilirubin < 1.5x ULN.
-
Patients with a prior history of low grade glioma who did not receive prior radiation or chemotherapy with transformation to grade IV brain tumor are eligible.
-
Women must be non-lactating, and surgically sterile, post-menopausal or have a negative serum pregnancy test and agree to use adequate birth control. Males must agree to use adequate birth control.
-
Voluntary, signed informed consent.
Exclusion Criteria:
-
Acute infection or other medical condition that would impair study treatment
-
No other active invasive malignancy unless disease free for at least 3 years.
-
Prior temozolomide or PPX.
-
Prior use of Gliadel wafers or any other intratumoral or intracavitary treatment are not permitted.
-
Prior radiotherapy to the head or neck (except for T1 glottic cancer), resulting in overlap of radiation fields.
-
No diffuse leptomeningeal disease, or gliomatosis cerebri.
-
Use of any other experimental chemotherapy drug within the 60 days prior to randomization and during the trial. (Use of a non-chemotherapy investigational agent must be approved by the Brown University Oncology Group)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UCSD Cancer Center | La Jolla | California | United States | 92093 |
| 2 | Maine Medical Center | Scarborough | Maine | United States | 04074 |
| 3 | UMASS Medical Center Cancer Center | Worcester | Massachusetts | United States | 01605 |
| 4 | SUNY Medical Center | Syracuse | New York | United States | 13210 |
| 5 | PSU | Hershey | Pennsylvania | United States | 17033 |
| 6 | Thomas Jefferson University Cancer Center | Philadelphia | Pennsylvania | United States | 19107 |
| 7 | Rhode Island Hospital | Providence | Rhode Island | United States | 02906 |
| 8 | UT Southwestern Cancer Center | Dallas | Texas | United States | 75235 |
| 9 | University of Washington | Seattle | Washington | United States | 98109 |
Sponsors and Collaborators
- Brown University
- Rhode Island Hospital
- Milton S. Hershey Medical Center
- University of Washington
- University of Massachusetts, Worcester
- MaineHealth
- University of California, San Diego
- Thomas Jefferson University
Investigators
- Principal Investigator: Howard Safran, MD, BrUOG
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
howard safran,
Principal Investigator,
Brown University
ClinicalTrials.gov Identifier:
NCT01402063
Other Study ID Numbers:
- BrUOG 244
First Posted:
Jul 26, 2011
Last Update Posted:
Feb 17, 2020
Last Verified:
Feb 1, 2020
Keywords provided by howard safran,
Principal Investigator,
Brown University
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Radiation Plus PPX(CT2103 | Radiation + Temozolomide |
|---|---|---|
| Arm/Group Description | Radiation therapy, Monday through Friday, for 6 weeks for a total of 30 treatments + intravenous PPX every week x 6 weeks for a total of 6 treatments PPX (CT2103): XRT: 60 Gy at 2 Gy/fraction x 30 fractions PPX: 50 mg/m2/week x 6 weeks during radiation Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum. | Radiation therapy, Monday through Friday, for 6 weeks for a total of 30 treatments + Daily oral temozolomide(TMZ) (7 days) x 6 wks for a total of 42 days Temozolomide: XRT: 60 Gy at 2 Gy/fraction x 30 fractions Temozolomide, 75 mg/m2/day, 7 days per week, from the first to the last day of radiotherapy Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum |
| Period Title: Overall Study | ||
| STARTED | 42 | 21 |
| COMPLETED | 39 | 18 |
| NOT COMPLETED | 3 | 3 |
Baseline Characteristics
| Arm/Group Title | Radiation Plus PPX(CT2103 | Radiation + Temozolomide | Total |
|---|---|---|---|
| Arm/Group Description | Radiation therapy, Monday through Friday, for 6 weeks for a total of 30 treatments + intravenous PPX every week x 6 weeks for a total of 6 treatments PPX (CT2103): XRT: 60 Gy at 2 Gy/fraction x 30 fractions PPX: 50 mg/m2/week x 6 weeks during radiation Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum. | Radiation therapy, Monday through Friday, for 6 weeks for a total of 30 treatments + Daily oral temozolomide(TMZ) (7 days) x 6 wks for a total of 42 days Temozolomide: XRT: 60 Gy at 2 Gy/fraction x 30 fractions Temozolomide, 75 mg/m2/day, 7 days per week, from the first to the last day of radiotherapy Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum | Total of all reporting groups |
| Overall Participants | 42 | 21 | 63 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
27
64.3%
|
15
71.4%
|
42
66.7%
|
| >=65 years |
15
35.7%
|
6
28.6%
|
21
33.3%
|
| Age (years) [Mean (Full Range) ] | |||
| Mean (Full Range) [years] |
62
|
62
|
62
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
15
35.7%
|
9
42.9%
|
24
38.1%
|
| Male |
27
64.3%
|
12
57.1%
|
39
61.9%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
42
100%
|
21
100%
|
63
100%
|
Outcome Measures
| Title | Progression Free Survival PPX/RT Versus TMZ/RT for Patients With GBM Without Methylation |
|---|---|
| Description | MRI response evaluated by RANO criteria Complete Response (CR): Circumstance when the enhancing tumor is no longer seen by neuroimaging, with the patient off all steroids or on adrenal maintenance only; CR will be coded only if confirmed by a second CT/MR scan performed a minimum of 4 weeks after the initial scan coding a response. Partial Response (PR): Decrease of > 50% in the product of two diameters. Patients should be receiving stable or decreasing doses of steroids. PR will be coded only if confirmed by a second CT/MR scan performed a minimum of 4 weeks after the initial scan. Progression (P): A > 25% increase in tumor area (two diameters) provided that the patient has not had his/her dose of steroids decreased since the last evaluation period. This will not need a confirmatory scan. A concomitant decrease in steroid dose will rule out a progression designation during the first 2 months after completion of XRT. |
| Time Frame | Q 3 months on study then Q3 months in f/u for yr 1, q 4 months yr 2, q 6 months for approximately 4 ys. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Radiation Plus PPX(CT2103 | Radiation + Temozolomide |
|---|---|---|
| Arm/Group Description | Radiation therapy, Monday through Friday, for 6 weeks for a total of 30 treatments + intravenous PPX every week x 6 weeks for a total of 6 treatments PPX (CT2103): XRT: 60 Gy at 2 Gy/fraction x 30 fractions PPX: 50 mg/m2/week x 6 weeks during radiation Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum. | Radiation therapy, Monday through Friday, for 6 weeks for a total of 30 treatments + Daily oral temozolomide(TMZ) (7 days) x 6 wks for a total of 42 days Temozolomide: XRT: 60 Gy at 2 Gy/fraction x 30 fractions Temozolomide, 75 mg/m2/day, 7 days per week, from the first to the last day of radiotherapy Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum |
| Measure Participants | 42 | 21 |
| Number [participants] |
31
73.8%
|
15
71.4%
|
Adverse Events
| Time Frame | Baseline, throughout all treatment, at study discontinuation and 30 days post last dose of drug | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Radiation Plus PPX and Maintenance | Radiation + Temozolomide and Maintenance | ||
| Arm/Group Description | Radiation therapy, Monday through Friday, for 6 weeks for a total of 30 treatments + intravenous PPX every week x 6 weeks for a total of 6 treatments PPX (CT2103): XRT: 60 Gy at 2 Gy/fraction x 30 fractions PPX: 50 mg/m2/week x 6 weeks during radiation Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum. | Radiation therapy, Monday through Friday, for 6 weeks for a total of 30 treatments + Daily oral temozolomide(TMZ) (7 days) x 6 wks for a total of 42 days Temozolomide: XRT: 60 Gy at 2 Gy/fraction x 30 fractions Temozolomide, 75 mg/m2/day, 7 days per week, from the first to the last day of radiotherapy Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum | ||
All Cause Mortality |
||||
| Radiation Plus PPX and Maintenance | Radiation + Temozolomide and Maintenance | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Radiation Plus PPX and Maintenance | Radiation + Temozolomide and Maintenance | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 13/41 (31.7%) | 7/18 (38.9%) | ||
| Investigations | ||||
| Anaphylactic Shock | 1/41 (2.4%) | 1 | 0/18 (0%) | 0 |
| Aspiration | 1/41 (2.4%) | 1 | 0/18 (0%) | 0 |
| Ataxia | 1/41 (2.4%) | 1 | 0/18 (0%) | 0 |
| Bowel Obstruction | 1/41 (2.4%) | 1 | 0/18 (0%) | 0 |
| Cardiac Event | 1/41 (2.4%) | 1 | 0/18 (0%) | 0 |
| Constipation | 1/41 (2.4%) | 1 | 1/18 (5.6%) | 1 |
| Dysphagia/Swallowing Difficulty | 1/41 (2.4%) | 1 | 0/18 (0%) | 0 |
| Dysphasia | 1/41 (2.4%) | 1 | 0/18 (0%) | 0 |
| Dyspnea/Shortness of Breath/COPD | 2/41 (4.9%) | 2 | 0/18 (0%) | 0 |
| Edema Cerebral/Brain Edema/Cerebral [Localized] Edema | 1/41 (2.4%) | 1 | 0/18 (0%) | 0 |
| Headache | 2/41 (4.9%) | 2 | 1/18 (5.6%) | 1 |
| Hemiparesis [Increasing] (LF Side) | 1/41 (2.4%) | 1 | 0/18 (0%) | 0 |
| Hyperglycemia | 2/41 (4.9%) | 2 | 0/18 (0%) | 0 |
| Hypocalcemia | 1/41 (2.4%) | 1 | 0/18 (0%) | 0 |
| Hypokalemia | 1/41 (2.4%) | 1 | 0/18 (0%) | 0 |
| Hypotension | 1/41 (2.4%) | 1 | 0/18 (0%) | 0 |
| Infection | 3/41 (7.3%) | 5 | 0/18 (0%) | 0 |
| Loss of Balance | 1/41 (2.4%) | 1 | 0/18 (0%) | 0 |
| Lymphopenia/Lymphocytopenia/Decreased Lymphocyte Count/Lymphocyte # Decreased | 1/41 (2.4%) | 2 | 0/18 (0%) | 0 |
| Mental Status Changes | 6/41 (14.6%) | 8 | 2/18 (11.1%) | 2 |
| Nausea/Increased Nausea/Nausea [Increasing] | 2/41 (4.9%) | 2 | 2/18 (11.1%) | 2 |
| Otitis (External)/ media/inflammation middle ear | 1/41 (2.4%) | 1 | 0/18 (0%) | 0 |
| Pain chest | 1/41 (2.4%) | 1 | 0/18 (0%) | 0 |
| Pulmonary Embolism | 1/41 (2.4%) | 1 | 1/18 (5.6%) | 1 |
| Seizure/Seizures | 2/41 (4.9%) | 3 | 2/18 (11.1%) | 3 |
| Stroke | 1/41 (2.4%) | 1 | 0/18 (0%) | 0 |
| Syncope | 1/41 (2.4%) | 1 | 0/18 (0%) | 0 |
| Thromboembolic Event | 1/41 (2.4%) | 1 | 1/18 (5.6%) | 1 |
| Vertigo | 1/41 (2.4%) | 1 | 0/18 (0%) | 0 |
| Vomitting | 1/41 (2.4%) | 1 | 1/18 (5.6%) | 1 |
| Weakness (generalized,proximal, LE proximal, LLE, Left UE and LE, arm) | 1/41 (2.4%) | 1 | 0/18 (0%) | 0 |
| PNEUMOPERITONEUM | 1/41 (2.4%) | 1 | 0/18 (0%) | 0 |
| WBC | 1/41 (2.4%) | 1 | 0/18 (0%) | 0 |
| SIADH | 1/41 (2.4%) | 1 | 0/18 (0%) | 0 |
| PLT | 1/41 (2.4%) | 1 | 1/18 (5.6%) | 1 |
| ANC | 1/41 (2.4%) | 1 | 0/18 (0%) | 0 |
| HCT | 1/41 (2.4%) | 1 | 0/18 (0%) | 0 |
| RBC | 1/41 (2.4%) | 1 | 0/18 (0%) | 0 |
| CSF elevated | 1/41 (2.4%) | 1 | 0/18 (0%) | 0 |
| Fever | 1/41 (2.4%) | 2 | 0/18 (0%) | 0 |
| Creatinine | 1/41 (2.4%) | 1 | 0/18 (0%) | 0 |
| Cough | 1/41 (2.4%) | 1 | 0/18 (0%) | 0 |
| Anemia | 1/41 (2.4%) | 1 | 0/18 (0%) | 0 |
| intratumoral hemorrhage | 0/41 (0%) | 0 | 1/18 (5.6%) | 1 |
| craniotomy | 0/41 (0%) | 0 | 1/18 (5.6%) | 1 |
| pancytopenia | 0/41 (0%) | 0 | 1/18 (5.6%) | 1 |
| pulseless electrical activity | 0/41 (0%) | 0 | 1/18 (5.6%) | 1 |
| Abdominal pain | 0/41 (0%) | 0 | 1/18 (5.6%) | 1 |
| Gallstones | 0/41 (0%) | 0 | 1/18 (5.6%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
| Radiation Plus PPX and Maintenance | Radiation + Temozolomide and Maintenance | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 40/41 (97.6%) | 18/18 (100%) | ||
| Investigations | ||||
| abnormal blood prolactin | 1/41 (2.4%) | 1 | 0/18 (0%) | 0 |
| abrasions/lacerations: face, leg, finger | 3/41 (7.3%) | 3 | 0/18 (0%) | 0 |
| Acute gastroenteritis | 1/41 (2.4%) | 1 | 0/18 (0%) | 0 |
| Acne On Face and B/L Inguinal Region | 1/41 (2.4%) | 1 | 0/18 (0%) | 0 |
| Agitation | 2/41 (4.9%) | 2 | 0/18 (0%) | 0 |
| Akathisia | 3/41 (7.3%) | 3 | 0/18 (0%) | 0 |
| ALC Low/ALC Decreased | 3/41 (7.3%) | 3 | 10/18 (55.6%) | 10 |
| Alk Phos Elevated | 3/41 (7.3%) | 3 | 0/18 (0%) | 0 |
| Alopecia | 22/41 (53.7%) | 22 | 3/18 (16.7%) | 3 |
| Allergic reaction | 0/41 (0%) | 0 | 1/18 (5.6%) | 1 |
| LFTS (ALT/AST) | 6/41 (14.6%) | 6 | 4/18 (22.2%) | 4 |
| Ambulatory Dysfunction | 1/41 (2.4%) | 1 | 0/18 (0%) | 0 |
| Anemia | 13/41 (31.7%) | 13 | 5/18 (27.8%) | 5 |
| Anorexia/Decreased Appetite/Loss of Appetite | 11/41 (26.8%) | 11 | 4/18 (22.2%) | 4 |
| Anxiety/Anxiety [Increasing] | 6/41 (14.6%) | 6 | 1/18 (5.6%) | 2 |
| apathy | 0/41 (0%) | 0 | 1/18 (5.6%) | 1 |
| Aphasia | 4/41 (9.8%) | 4 | 0/18 (0%) | 0 |
| Aphasia (Motor) | 1/41 (2.4%) | 1 | 0/18 (0%) | 0 |
| Appetite (Increased) | 4/41 (9.8%) | 4 | 0/18 (0%) | 0 |
| Bells palsy | 0/41 (0%) | 0 | 1/18 (5.6%) | 1 |
| BILATERAL CAROTID BRUIT | 1/41 (2.4%) | 1 | 0/18 (0%) | 0 |
| Blurred Vision/Blurry Vision/homonymous hemianopsia(left)/cataracts/periorbital pressure | 16/41 (39%) | 16 | 1/18 (5.6%) | 1 |
| Bloody mucous | 0/41 (0%) | 0 | 1/18 (5.6%) | 1 |
| Bowel Incontinence | 1/41 (2.4%) | 1 | 0/18 (0%) | 0 |
| Bruising | 1/41 (2.4%) | 1 | 0/18 (0%) | 0 |
| BUN lab | 1/41 (2.4%) | 1 | 0/18 (0%) | 0 |
| CD4 Count Decreased | 3/41 (7.3%) | 3 | 5/18 (27.8%) | 5 |
| congestion/chest/ear | 4/41 (9.8%) | 4 | 0/18 (0%) | 0 |
| Chills | 1/41 (2.4%) | 1 | 0/18 (0%) | 0 |
| Chronic Obstructive Pulmonary Disease | 1/41 (2.4%) | 1 | 0/18 (0%) | 0 |
| Cholesterol | 6/41 (14.6%) | 6 | 0/18 (0%) | 0 |
| Constipation | 9/41 (22%) | 9 | 6/18 (33.3%) | 6 |
| cough | 4/41 (9.8%) | 4 | 1/18 (5.6%) | 1 |
| cramping | 0/41 (0%) | 0 | 1/18 (5.6%) | 1 |
| creatinine | 4/41 (9.8%) | 4 | 1/18 (5.6%) | 1 |
| CSF elevated protein and collection | 1/41 (2.4%) | 1 | 0/18 (0%) | 0 |
| Cushingoid face | 4/41 (9.8%) | 4 | 1/18 (5.6%) | 1 |
| DARK LESION WITH IRREGULAR BORDERS - RIGHT MEDIAL ANKLE (BENIGN) | 1/41 (2.4%) | 1 | 0/18 (0%) | 0 |
| decreased arm swing | 6/41 (14.6%) | 6 | 2/18 (11.1%) | 2 |
| Dehydration | 5/41 (12.2%) | 5 | 2/18 (11.1%) | 2 |
| Depression | 5/41 (12.2%) | 5 | 2/18 (11.1%) | 2 |
| Dermatitis | 1/41 (2.4%) | 1 | 2/18 (11.1%) | 2 |
| Diarrhea | 5/41 (12.2%) | 5 | 2/18 (11.1%) | 2 |
| Dizziness | 10/41 (24.4%) | 10 | 0/18 (0%) | 0 |
| dry mouth | 2/41 (4.9%) | 2 | 0/18 (0%) | 0 |
| Dry skin | 1/41 (2.4%) | 1 | 0/18 (0%) | 0 |
| Dysphagia/Swallowing Difficulty | 2/41 (4.9%) | 2 | 0/18 (0%) | 0 |
| Dyspnea/Shortness of Breath | 7/41 (17.1%) | 7 | 1/18 (5.6%) | 1 |
| dysgeuisa | 2/41 (4.9%) | 2 | 5/18 (27.8%) | 5 |
| dyspepsia | 0/41 (0%) | 0 | 1/18 (5.6%) | 1 |
| Edema Cerebral/Brain Edema/Cerebral [Localized] Edema | 3/41 (7.3%) | 3 | 0/18 (0%) | 0 |
| Edema face/neck/hands | 1/41 (2.4%) | 1 | 3/18 (16.7%) | 3 |
| Eosinophil count increased | 1/41 (2.4%) | 1 | 0/18 (0%) | 0 |
| erythema | 2/41 (4.9%) | 2 | 1/18 (5.6%) | 1 |
| Fatigue/Increased | 29/41 (70.7%) | 29 | 16/18 (88.9%) | 19 |
| Facial Asymmetry | 2/41 (4.9%) | 2 | 0/18 (0%) | 0 |
| Fever | 4/41 (9.8%) | 4 | 1/18 (5.6%) | 1 |
| Flushing | 1/41 (2.4%) | 1 | 0/18 (0%) | 0 |
| flu like symptoms | 0/41 (0%) | 0 | 1/18 (5.6%) | 1 |
| Forehead trauma | 1/41 (2.4%) | 1 | 0/18 (0%) | 0 |
| fracture | 0/41 (0%) | 0 | 1/18 (5.6%) | 1 |
| Gait Unsteadiness/Unsteady Gait/proprioception/ cirumduction, motor deficit | 9/41 (22%) | 9 | 1/18 (5.6%) | 1 |
| GERD | 3/41 (7.3%) | 3 | 0/18 (0%) | 0 |
| Gum soarness | 1/41 (2.4%) | 1 | 0/18 (0%) | 0 |
| Hand Cramping | 3/41 (7.3%) | 3 | 0/18 (0%) | 0 |
| Hand tremor | 1/41 (2.4%) | 1 | 0/18 (0%) | 0 |
| Headache/Headache (Bifrontal)/Headache [Intermittent]/pressure | 17/41 (41.5%) | 17 | 9/18 (50%) | 9 |
| Hearing loss | 1/41 (2.4%) | 1 | 0/18 (0%) | 0 |
| Hernia | 0/41 (0%) | 0 | 1/18 (5.6%) | 1 |
| Hemorrhage (Intratumoral) | 1/41 (2.4%) | 1 | 0/18 (0%) | 0 |
| Hoarseness (Hoarse Voice) | 1/41 (2.4%) | 1 | 0/18 (0%) | 0 |
| Hypoalbuminemia | 1/41 (2.4%) | 1 | 0/18 (0%) | 0 |
| Hypocalcemia | 2/41 (4.9%) | 2 | 1/18 (5.6%) | 1 |
| Hyperglycemia | 14/41 (34.1%) | 14 | 4/18 (22.2%) | 4 |
| Hypoglycemia | 2/41 (4.9%) | 2 | 0/18 (0%) | 0 |
| hyperlipidemia | 0/41 (0%) | 0 | 1/18 (5.6%) | 1 |
| Hypertension | 1/41 (2.4%) | 1 | 1/18 (5.6%) | 1 |
| Hypotension | 1/41 (2.4%) | 1 | 0/18 (0%) | 0 |
| Hypertriglyceridemia | 2/41 (4.9%) | 2 | 1/18 (5.6%) | 1 |
| Hypokalemia | 10/41 (24.4%) | 10 | 2/18 (11.1%) | 2 |
| Hyperkalemia | 1/41 (2.4%) | 1 | 0/18 (0%) | 0 |
| Hypernatremia | 1/41 (2.4%) | 1 | 0/18 (0%) | 0 |
| Hypomagnesemia | 0/41 (0%) | 0 | 1/18 (5.6%) | 1 |
| Hypersensitivity to noise | 1/41 (2.4%) | 1 | 0/18 (0%) | 0 |
| Hyponatremia | 9/41 (22%) | 9 | 2/18 (11.1%) | 2 |
| Hypothyroidism | 1/41 (2.4%) | 1 | 0/18 (0%) | 0 |
| increased sputum | 1/41 (2.4%) | 1 | 0/18 (0%) | 0 |
| incisional tenderness | 0/41 (0%) | 0 | 1/18 (5.6%) | 1 |
| Infection | 15/41 (36.6%) | 17 | 5/18 (27.8%) | 5 |
| Insomnia | 10/41 (24.4%) | 10 | 5/18 (27.8%) | 5 |
| Infusion Related Reaction | 1/41 (2.4%) | 1 | 0/18 (0%) | 0 |
| itchiness | 2/41 (4.9%) | 2 | 0/18 (0%) | 0 |
| intratumoral hemorrhage | 1/41 (2.4%) | 1 | 0/18 (0%) | 0 |
| jaw stiffness/tenderness | 0/41 (0%) | 0 | 1/18 (5.6%) | 1 |
| joint stiffness | 3/41 (7.3%) | 3 | 0/18 (0%) | 0 |
| Leukopenia | 10/41 (24.4%) | 10 | 2/18 (11.1%) | 2 |
| Lipase increase | 1/41 (2.4%) | 1 | 0/18 (0%) | 0 |
| Lower Extremity Edema (Bilateral)/ foot swelling | 6/41 (14.6%) | 6 | 0/18 (0%) | 0 |
| Lymphopenia/Lymphocytopenia/Decreased Lymphocyte Count/Lymphocyte # Decreased | 11/41 (26.8%) | 11 | 6/18 (33.3%) | 6 |
| Memory Loss (Worsening Short Term)/memory impairment | 7/41 (17.1%) | 7 | 1/18 (5.6%) | 1 |
| Mental Status Changes | 11/41 (26.8%) | 11 | 1/18 (5.6%) | 1 |
| mucous production increased | 0/41 (0%) | 0 | 1/18 (5.6%) | 1 |
| myopathy | 0/41 (0%) | 0 | 1/18 (5.6%) | 1 |
| narcolepsy | 1/41 (2.4%) | 1 | 0/18 (0%) | 0 |
| Nausea/Increased Nausea/Nausea [Increasing] | 21/41 (51.2%) | 21 | 11/18 (61.1%) | 11 |
| Neutropenia | 6/41 (14.6%) | 6 | 3/18 (16.7%) | 3 |
| Otitis (External)/ media/inflammation middle ear/tinnitus | 5/41 (12.2%) | 5 | 0/18 (0%) | 0 |
| Ear pain/pressure | 0/41 (0%) | 0 | 1/18 (5.6%) | 1 |
| Pain | 12/41 (29.3%) | 17 | 5/18 (27.8%) | 6 |
| Paresthesia (Hand)/LE/oral/neuropathy | 8/41 (19.5%) | 8 | 2/18 (11.1%) | 2 |
| PLTs | 17/41 (41.5%) | 17 | 6/18 (33.3%) | 6 |
| pain post herpatic neuralgia | 0/41 (0%) | 0 | 1/18 (5.6%) | 1 |
| Rash/skin irritation,seborrheic keratosis, desquamation of skin, maculopapular rash | 6/41 (14.6%) | 6 | 4/18 (22.2%) | 4 |
| pruritis | 0/41 (0%) | 0 | 2/18 (11.1%) | 2 |
| Psoriatic nails | 0/41 (0%) | 0 | 1/18 (5.6%) | 1 |
| Scrotal discomfort | 1/41 (2.4%) | 1 | 0/18 (0%) | 0 |
| Seizure/Seizures | 7/41 (17.1%) | 7 | 1/18 (5.6%) | 1 |
| sensory loss | 1/41 (2.4%) | 1 | 0/18 (0%) | 0 |
| sinusitis/post nasal | 0/41 (0%) | 0 | 2/18 (11.1%) | 2 |
| Skin lesions/ulceration | 2/41 (4.9%) | 2 | 0/18 (0%) | 0 |
| Somnolence | 1/41 (2.4%) | 1 | 0/18 (0%) | 0 |
| Swelling of Scalp [at Incision Site and Right Eyelid] | 1/41 (2.4%) | 1 | 0/18 (0%) | 0 |
| spasm extremity | 0/41 (0%) | 0 | 1/18 (5.6%) | 1 |
| Speech issues/vocal change | 2/41 (4.9%) | 2 | 0/18 (0%) | 0 |
| Stroke | 1/41 (2.4%) | 1 | 0/18 (0%) | 0 |
| Syncope | 1/41 (2.4%) | 1 | 0/18 (0%) | 0 |
| systolic murmur | 1/41 (2.4%) | 1 | 0/18 (0%) | 0 |
| Tachycardia (Sinus) | 3/41 (7.3%) | 3 | 0/18 (0%) | 0 |
| Tachypnea | 1/41 (2.4%) | 1 | 0/18 (0%) | 0 |
| Tooth ache | 1/41 (2.4%) | 1 | 1/18 (5.6%) | 1 |
| Tremor | 3/41 (7.3%) | 3 | 0/18 (0%) | 0 |
| Thromboembolic Event | 1/41 (2.4%) | 1 | 0/18 (0%) | 0 |
| ulcer | 0/41 (0%) | 0 | 1/18 (5.6%) | 1 |
| Urinary Incontinence | 2/41 (4.9%) | 2 | 0/18 (0%) | 0 |
| Urinary frequency | 3/41 (7.3%) | 3 | 2/18 (11.1%) | 2 |
| Wasting (General) | 1/41 (2.4%) | 1 | 0/18 (0%) | 0 |
| Watering eyes | 1/41 (2.4%) | 1 | 1/18 (5.6%) | 1 |
| Weakness (generalized,proximal, LE proximal, LLE, Left UE and LE, arm) | 15/41 (36.6%) | 15 | 1/18 (5.6%) | 1 |
| Weight Gain | 3/41 (7.3%) | 3 | 1/18 (5.6%) | 1 |
| Weight Loss | 5/41 (12.2%) | 5 | 3/18 (16.7%) | 3 |
| Wheezing | 1/41 (2.4%) | 1 | 0/18 (0%) | 0 |
| Vomiting | 4/41 (9.8%) | 4 | 1/18 (5.6%) | 1 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Howard Safran, MD |
|---|---|
| Organization | Brown University Oncology Research Group (BrUOG) |
| Phone | 4018633000 |
| kayla_rosati@brown.edu |
Responsible Party:
howard safran,
Principal Investigator,
Brown University
ClinicalTrials.gov Identifier:
NCT01402063
Other Study ID Numbers:
- BrUOG 244
First Posted:
Jul 26, 2011
Last Update Posted:
Feb 17, 2020
Last Verified:
Feb 1, 2020