Karenitecin in Treating Patients With Recurrent Malignant Glioma

• 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.

PURPOSE: Phase I trial to study the effectiveness of karenitecin in treating patients who have recurrent malignant glioma.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Camptothecin

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed anaplastic astrocytoma, anaplastic oligodendroglioma, or glioblastoma multiforme

• Progressive or recurrent disease previously treated with radiotherapy with or without chemotherapy

• Prior low-grade disease that progressed to high-grade after therapy allowed

• Measurable disease by MRI or CT scan

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Karnofsky 60-100%

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm3

• Hemoglobin at least 8.5 g/dL

Hepatic:

• Bilirubin no greater than 1.5 mg/dL

• Transaminases no greater than 4 times upper limit of normal

Renal:

• Creatinine no greater than 1.7 mg/dL

Other:

• No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix or breast

• No serious concurrent infection

• No other medical illness that would preclude study

• Negative pregnancy test

• Not pregnant or nursing

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• See Disease Characteristics

• At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered

• No more than 1 prior chemotherapy regimen

Endocrine therapy:

• Must be on stable dose of steroids for at least 5 days

Radiotherapy:

• See Disease Characteristics

• At least 3 months since prior radiotherapy and recovered

• No more than 1 prior course of radiotherapy

Surgery:

• Not specified

Other:

• No other concurrent investigational agents

• At least 10 days since prior anticonvulsant drugs that induce hepatic metabolic enzymes