Atrasentan in Treating Patients With Progressive or 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 cancer cells from dividing so they stop growing or die.

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

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

Details

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

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed malignant glioma

• Anaplastic astrocytoma

• Anaplastic oligodendroglioma

• Glioblastoma multiforme

• Progressive or recurrent after prior radiotherapy with or without chemotherapy

• Prior low-grade glioma that has 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/mm^3

Hepatic:

• Bilirubin no greater than 1.5 mg/dL

• Transaminases no greater than 4 times upper limit of normal

• Hepatitis A, B, and C negative

Renal:

• Creatinine no greater than 1.7 mg/dL

Cardiovascular:

• No New York Heart Association class II, III, or IV cardiac disease

Other:

• HIV negative

• Mini mental score at least 15

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

• No serious concurrent infection

• No other concurrent medical illness that would preclude study entry

• No alcoholism or drug addiction within the past 6 months

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No concurrent anticancer immunotherapy

Chemotherapy:

• See Disease Characteristics

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

• No more than 1 prior chemotherapy regimen

• No prior or concurrent polifeprosan 20 with carmustine implant (Gliadel wafer)

• No prior atrasentan

• No other concurrent anticancer chemotherapy

Endocrine therapy:

• No concurrent anticancer hormonal therapy

Radiotherapy:

• See Disease Characteristics

• At least 3 months since prior radiotherapy and recovered

• No concurrent anticancer radiotherapy

Surgery:

• No concurrent anticancer surgery

Other:

• Recovered from prior therapy

• No more than 1 prior treatment regimen

• No other concurrent investigational agents