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Carboplatin Plus Irinotecan in Treating Patients With Glioblastoma Multiforme

Primary Purpose

Brain and Central Nervous System Tumors

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
carboplatin
irinotecan hydrochloride
radiation therapy
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed glioblastoma multiforme Measurable disease No CNS metastases or carcinomatous meningitis PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 OR Karnofsky 70-100% Life expectancy: At least 12 weeks Hematopoietic: Granulocyte count greater than 1,500/mm^3 Platelet count greater than 100,000/mm^3 Hemoglobin at least 9.0 g/dL Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT no greater than 3 times upper limit of normal (ULN) (5 times ULN if liver involvement) No known Gilbert's syndrome Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No myocardial infarction within the past 6 months No congestive heart failure requiring therapy Other: HIV negative No active or uncontrolled infection No psychiatric disorder that would preclude study No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix No uncontrolled diabetes mellitus (i.e., random blood sugar of 200 mg or more) No other severe disease that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy or biologic therapy No concurrent sargramostim (GM-CSF) No concurrent filgrastim (G-CSF) with course 1 No concurrent immunotherapy Chemotherapy: No prior chemotherapy No other concurrent chemotherapy Endocrine therapy: Must have maintained a stable or decreasing dose of corticosteroids for 2 weeks prior to study Concurrent corticosteroids for cerebral edema allowed No concurrent anticancer hormonal therapy Radiotherapy: No prior radiotherapy No concurrent radiotherapy Surgery: At least 2 weeks since prior surgery Other: No other concurrent investigational agent or participation on any other clinical study No concurrent immunosuppressive drugs No concurrent phenobarbital or valproic acid No concurrent anticonvulsants except carbamazepine or gabapentin No concurrent prochlorperazine on day of irinotecan treatment

Sites / Locations

  • NYU School of Medicine's Kaplan Comprehensive Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 2, 2001
Last Updated
March 25, 2011
Sponsor
NYU Langone Health
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00010036
Brief Title
Carboplatin Plus Irinotecan in Treating Patients With Glioblastoma Multiforme
Official Title
A Phase I/II Trial of CPT-11 With Carboplatin in Patients With Glioblastoma Multiforme Prior to Radiation Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
May 1999 (undefined)
Primary Completion Date
October 2001 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
NYU Langone Health
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining carboplatin with irinotecan in treating patients who have glioblastoma multiforme.
Detailed Description
OBJECTIVES: Determine the maximum tolerated dose (MTD) of carboplatin and irinotecan in patients with glioblastoma multiforme. (Phase I closed to accrual as of 6/24/02) Determine the toxic effects of this regimen in these patients. Determine the objective response in patients treated with the established MTD of this regimen. Determine time to tumor progression and survival of patients treated with this regimen. OUTLINE: This is a dose-escalation study. Patients in the phase II portion of the study are stratified according to age (under 60 vs 60 and over), ECOG performance status (0-1 vs 2), and extent of resection (total vs subtotal). (Phase I closed to accrual as of 6/24/02) Within 4 weeks of surgery, patients receive carboplatin IV over 30 minutes followed by irinotecan IV over 90 minutes on day 1. Treatment repeats every 4 weeks for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of carboplatin and irinotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are accrued to receive carboplatin and irinotecan at the recommended phase II dose. (Phase I closed to accrual as of 6/24/02) After chemotherapy, all patients undergo radiotherapy. Patients are followed for 30 days. PROJECTED ACCRUAL: A total of 24-107 patients (3-54 for phase I and 21-53 for phase II) will be accrued for this study. (Phase I closed to accrual as of 6/24/02)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors
Keywords
adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Type
Drug
Intervention Name(s)
irinotecan hydrochloride
Intervention Type
Radiation
Intervention Name(s)
radiation therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed glioblastoma multiforme Measurable disease No CNS metastases or carcinomatous meningitis PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 OR Karnofsky 70-100% Life expectancy: At least 12 weeks Hematopoietic: Granulocyte count greater than 1,500/mm^3 Platelet count greater than 100,000/mm^3 Hemoglobin at least 9.0 g/dL Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT no greater than 3 times upper limit of normal (ULN) (5 times ULN if liver involvement) No known Gilbert's syndrome Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No myocardial infarction within the past 6 months No congestive heart failure requiring therapy Other: HIV negative No active or uncontrolled infection No psychiatric disorder that would preclude study No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix No uncontrolled diabetes mellitus (i.e., random blood sugar of 200 mg or more) No other severe disease that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy or biologic therapy No concurrent sargramostim (GM-CSF) No concurrent filgrastim (G-CSF) with course 1 No concurrent immunotherapy Chemotherapy: No prior chemotherapy No other concurrent chemotherapy Endocrine therapy: Must have maintained a stable or decreasing dose of corticosteroids for 2 weeks prior to study Concurrent corticosteroids for cerebral edema allowed No concurrent anticancer hormonal therapy Radiotherapy: No prior radiotherapy No concurrent radiotherapy Surgery: At least 2 weeks since prior surgery Other: No other concurrent investigational agent or participation on any other clinical study No concurrent immunosuppressive drugs No concurrent phenobarbital or valproic acid No concurrent anticonvulsants except carbamazepine or gabapentin No concurrent prochlorperazine on day of irinotecan treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael L. Gruber, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Study Chair
Facility Information:
Facility Name
NYU School of Medicine's Kaplan Comprehensive Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

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Carboplatin Plus Irinotecan in Treating Patients With Glioblastoma Multiforme

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