Carboplatin Plus Irinotecan in Treating Patients With Glioblastoma Multiforme

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York University School of Medicine; NYU Langone Health
• Collaborator: National Cancer Institute (NCI)
• Treatments: Carboplatin; Irinotecan

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