Carboplatin Plus Irinotecan in Treating Patients With Glioblastoma Multiforme

Brain and Central Nervous System Tumors Clinical Trial

Official title:

A Phase I/II Trial of CPT-11 With Carboplatin in Patients With Glioblastoma Multiforme Prior to Radiation Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00010036
• Other study ID #: CDR0000068435
• Secondary ID: P30CA016087NYU-9
• Status: Completed
• Phase: Phase 2
• First received: February 2, 2001
• Last updated: March 25, 2011
• Start date: May 1999

Study information

• Verified date: March 2011
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: October 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Glioblastoma
• Nervous System Neoplasms

Intervention

Drug:
• carboplatin

• irinotecan hydrochloride

Radiation:
• radiation therapy

Locations

Country	Name	City	State
United States	NYU School of Medicine's Kaplan Comprehensive Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York University School of Medicine	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,