Pyrazoloacridine Plus Carboplatin in Treating Patients With Recurrent Glioma

• Status: Completed
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Phase I/II trial to study the effectiveness of pyrazoloacridine plus carboplatin in treating patients who have recurrent glioma. 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.

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

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Carboplatin; NSC 366140

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed primary brain glioma

• Diffuse astrocytoma

• Gliosarcoma

• Oligodendroglioma

• Oligoastrocytoma

• Progressive disease after radiotherapy

• Measurable or evaluable disease by MRI or CT

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Hematopoietic:

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

• Platelet count at least 100,000/mm^3

• Hemoglobin at least 9 g/dL

Hepatic:

• Bilirubin no greater than upper limit of normal (ULN)

• SGOT no greater than 2.5 times ULN

Renal:

• Creatinine no greater than 2.0 mg/dL

Cardiovascular:

• No myocardial infarction within the past 6 months

• No congestive heart failure requiring therapy

Other:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No uncontrolled infection

• No other active malignancy

• No other concurrent severe disease

PRIOR CONCURRENT THERAPY:

Chemotherapy:

• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)

• No more than 1 prior adjuvant chemotherapy regimen

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

• Study 3 only:

• 1 prior chemotherapy regimen for recurrent disease allowed

• Prior nonplatinum-containing adjuvant chemotherapy allowed

• Prior platinum-containing adjuvant chemotherapy allowed if disease progressed at least 6 months after last treatment

Endocrine therapy:

• Non-increasing dose of corticosteroids for at least 1 week allowed

Radiotherapy:

• At least 12 weeks since prior radiotherapy

• No prior stereotactic radiosurgery or interstitial brachytherapy unless at least one lesion outside of irradiated area

Surgery:

• No surgical resection since prior radiotherapy or chemotherapy unless evidence of disease progression or lesion outside of treatment site

Other:

• Study 1 only: (Study 1 closed as of 03/29/02)

• Must be on anticonvulsants that can induce cytochrome P-450 (phenytoin, carbamazepine, barbiturates, or primidone)

• Study 2 only: (Study 2 closed as of 03/29/02)

• No concurrent anticonvulsants