Chemotherapy in Treating Patients With Progressive or Recurrent Brain Tumors

• Status: Completed
• Trial end date: 2003-10-01
• 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/II trial to study the effectiveness of irofulven in treating patients who have progressive or recurrent astrocytoma, oligodendroglioma, or glioblastoma multiforme.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New Approaches to Brain Tumor Therapy Consortium
• Collaborator: National Cancer Institute (NCI)
• Treatments: Irofulven

Criteria

DISEASE CHARACTERISTICS:

• Histologically proven malignant high-grade glioma that is progressive or recurrent after radiotherapy and/or chemotherapy

• Anaplastic astrocytoma

• Anaplastic oligodendroglioma

• Glioblastoma multiforme

• Prior low-grade glioma that has progressed to high-grade glioma after radiotherapy and/or chemotherapy 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/mm^3

Hepatic:

• Bilirubin no greater than 1.5 mg/dL

• Transaminases no greater than 2.5 times upper limit of normal

Renal:

• Creatinine no greater than 1.5 mg/dL

Other:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No serious concurrent infection or medical illness that would preclude study therapy

• No other prior 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

• Mini mental score at least 15

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• See Disease Characteristics

• No more than 2 prior chemotherapy regimens

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

Endocrine therapy:

• Maintained on a stable corticosteroid regimen for at least 5 days before and during study

Radiotherapy:

• See Disease Characteristics

• At least 3 months since prior radiotherapy and recovered

Surgery:

• Recovered from prior surgery

Other:

• No other concurrent investigational agents