Temozolomide and O6-benzylguanine in Treating Patients With Newly Diagnosed, Recurrent, or Progressive Anaplastic Glioma

• Status: Completed
• Trial end date: 2004-08-01
• 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. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of combining temozolomide and O6-benzylguanine in treating patients who have newly diagnosed, recurrent, or progressive anaplastic glioma.

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

Details

• Lead Sponsor: Duke University
• Collaborator: National Cancer Institute (NCI)
• Treatments: O(6)-benzylguanine; Temozolomide

Criteria

DISEASE CHARACTERISTICS:

• Part I:

• Histologically confirmed, newly diagnosed glioblastoma multiforme or anaplastic astrocytoma (closed to accrual 12/19/2000)

• Parts I and II:

• Histologically confirmed astrocytic, oligodendroglial, or mixed glial tumor

• Grade III or higher

• Recurrent or progressive after radiotherapy

• Evaluable residual disease by contrast-enhanced MRI or CT scan

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Karnofsky 60-100%

Life expectancy:

• Not specified

Hematopoietic:

• Granulocyte count at least 1,500/mm3

• Platelet count at least 100,000/mm3

Hepatic:

• SGOT no greater than 2.5 times upper limit of normal

• Bilirubin normal

Renal:

• Creatinine no greater than 1.5 mg/dL OR

• Creatinine clearance greater than 60 mL/min

• BUN no greater than 25 mg/dL

Other:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 2 months after study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 6 weeks since prior biologic therapy and recovered

Chemotherapy:

• At least 2 weeks since prior chemotherapy (including but not limited to topotecan) and recovered

• Patients in trials with one of the following treatment combinations are allowed to enroll 6 weeks after receiving carmustine (BCNU):

• BCNU on day 1

• BCNU on day 1 and topotecan on days 1, 8, 15, 22, 29, and 36

• BCNU on day 1 and irinotecan on days 1, 8, 15, and 22

Endocrine therapy:

• Patients on corticosteroids must be on a stable dose for at least 2 weeks before study

• At least 6 weeks since other prior endocrine therapy and recovered

Radiotherapy:

• See Disease Characteristics

• At least 6 weeks since prior radiotherapy and recovered

Surgery:

• Not specified