Irinotecan Plus Temozolomide in Treating Patients With Recurrent Primary Malignant Glioma

• Status: Completed
• Trial end date: 2006-04-01
• 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 irinotecan plus temozolomide in treating patients who have recurrent primary malignant glioma.

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

Details

• Lead Sponsor: Duke University
• Collaborator: National Cancer Institute (NCI)
• Treatments: Camptothecin; Irinotecan; Temozolomide

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed recurrent primary malignant glioma

• Anaplastic astrocytoma

• Glioblastoma multiforme

• Anaplastic oligodendroglioma

• Gliosarcoma

• Anaplastic mixed oligoastrocytoma

• Measurable disease by MRI or CT

• No immediate radiotherapy required

• Neurologically stable for at least 2 weeks prior to study

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Karnofsky 60-100%

Life expectancy:

• Greater than 12 weeks

Hematopoietic:

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

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

• Hemoglobin at least 10 g/dL

Hepatic:

• Bilirubin less than 1.5 times upper limit of normal (ULN)

• SGOT and SGPT less than 2.5 times ULN

• Alkaline phosphatase less than 2 times ULN

Renal:

• Blood urea nitrogen and creatinine less than 1.5 times ULN

Other:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• HIV negative

• No other nonmalignant systemic disease

• No acute infection treated with IV antibiotics

• No frequent vomiting or other condition that would preclude oral medication administration (e.g., partial bowel obstruction)

• No other prior malignancies except surgically cured carcinoma in situ of the cervix or basal or squamous cell skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No more than 1 prior biologic therapy regimen

Chemotherapy:

• No more than 1 prior chemotherapy regimen

• At least 6 weeks since prior chemotherapy, unless evidence of disease progression

• No prior failure of irinotecan or temozolomide

Endocrine therapy:

• Concurrent corticosteroids allowed

Radiotherapy:

• See Disease Characteristics

• At least 6 weeks since prior radiotherapy, unless evidence of disease progression

Surgery:

• At least 3 weeks since prior surgery, unless evidence of disease progression, and recovered

Other:

• No concurrent immunosuppressive agents