Temozolomide in Treating Patients With Primary Brain Tumors or Metastatic Brain Tumors

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Collecting fluid samples through a catheter may help doctors find out how well temozolomide spreads throughout the brain.

PURPOSE: This clinical trial is studying temozolomide in treating patients with primary brain tumors or metastatic brain tumors.

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

Details

• Lead Sponsor: City of Hope Medical Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Dacarbazine; Temozolomide

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of a primary or metastatic brain tumor for which temozolomide would be an appropriate chemotherapy treatment postoperatively

• Disease requires a debulking craniotomy or a stereotactic biopsy to diagnose or differentiate between tumor progression and treatment-induced effects after radiotherapy with or without chemotherapy

PATIENT CHARACTERISTICS:

• Karnofsky performance status 60-100%

• ANC ≥ 1,500/mm³

• Platelet count ≥ 100,000/mm³

• Total bilirubin ≤ 2.0 mg/dL

• AST ≤ 4 times upper limit of normal (ULN)

• Creatinine ≤ 1.5 time ULN

• Mini Mental Status Exam score ≥ 15

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No allergy to temozolomide

• No serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of study treatment

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• Recovered from prior therapy

• No concurrent chemotherapy or radiotherapy during the period of time that the microdialysis catheter is placed intracerebrally and until it is removed