Temozolomide in Treating Patients With Brain Metastases

• Status: Completed
• Trial end date: 2003-06-01
• 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 II trial to study the effectiveness of temozolomide in treating patients who have brain metastases.

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

Details

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

Criteria

DISEASE CHARACTERISTICS:

• Metastatic lesions to the brain

• Must not require immediate radiotherapy

• If received prior radiotherapy, must have progressive disease

• Evaluable disease by CT scan or MRI

• Neurologically stable

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Karnofsky 70-100%

Life expectancy:

• More 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 or SGPT less than 2.5 times ULN

• Alkaline phosphatase less than 2 times ULN

Renal:

• Blood urea nitrogen less than 1.5 times ULN

• Creatinine less than 1.5 times ULN

Other:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No other concurrent nonmalignant systemic disease

• No acute infection requiring treatment with IV antibiotics

• HIV negative

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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No concurrent hematopoietic growth factors, including epoetin alfa

• No other concurrent biologic therapy

Chemotherapy:

• At least 4 weeks since prior chemotherapy, unless evidence of disease progression

• No other concurrent chemotherapy

Endocrine therapy:

• Concurrent corticosteroids allowed if nonincreasing dose for at least 1 week prior to study

Radiotherapy:

• See Disease Characteristics

• At least 4 weeks since prior radiotherapy to the brain, unless evidence of disease progression

• No concurrent radiotherapy

Surgery:

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

Other:

• No other concurrent investigational drugs