Carmustine Implants in Treating Patients With Brain Metastases

• Status: Completed
• Trial end date: 2003-04-01
• 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. Giving the drugs in different ways may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of implanted carmustine wafers in treating patients who have brain metastases and who are undergoing surgery to remove the tumor.

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

Details

• Lead Sponsor: New Approaches to Brain Tumor Therapy Consortium
• Collaborator: National Cancer Institute (NCI)
• Treatments: Carmustine

Criteria

DISEASE CHARACTERISTICS:

• Supratentorial brain metastases for which surgery is recommended

• Solitary, unilateral, intracranial mass consistent with metastasis on MRI scan OR

• Two brain lesions consistent with metastases on MRI scan

• Lesions must be accessible through a single craniotomy

• Metastatic lesions clearly distinct from tumor bed of any benign lesions

• Intraoperative frozen section diagnosis of metastatic tumor from CNS lesion

• No prior malignant intracranial neoplasm

• No lesion(s) in the brainstem

• No open communication of the resection cavity with the ventricle following resection

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Karnofsky 60-100%

Life expectancy

• At least 3 months

Hematopoietic

• No concurrent hematologic disorders

Hepatic

• No concurrent hepatic disease

Renal

• No concurrent renal disease

Cardiovascular

• No concurrent cardiac disease

Pulmonary

• No concurrent pulmonary disorders

Other

• Not pregnant or nursing

• Fertile patients must use effective contraception

• Mini mental score at least 15

• No known hypersensitivity to carmustine or Gliadel wafers

• No other serious concurrent medical illness or infection

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• No prior cranial irradiation

Surgery

• See Disease Characteristics

• No prior surgery involving brain metastases or primary brain tumor(s) (except for benign intracranial lesions such as pituitary adenoma, meningioma, or schwannoma)

Other

• Concurrent systemic therapy allowed