Bendamustine and Radiation Therapy in Treating Patients With Brain Metastases Caused by Solid Tumors

• Status: Completed
• Trial end date: 2015-01-08
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as bendamustine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue.

PURPOSE: This phase I trial is studying the side effects and best dose of bendamustine when given together with radiation therapy in treating patients with brain metastases caused by solid tumors.

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

Details

• Lead Sponsor: John Grecula
• Collaborator: National Comprehensive Cancer Network
• Treatments: Bendamustine Hydrochloride

Criteria

Inclusion Criteria:

• Histologically confirmed cancer with 1 to 4 brain metastases imaged by MRI/CT scans not involving thalamus, basal ganglia or brain stem.

• No cancer originating in central nervous system

• Candidate for clinically indicated surgery to resect brain lesions.

• Karnofsky score of at least 60

• At least 18 years of age

• Life expectancy of more than two months

Exclusion Criteria:

• Evidence of leptomeningeal metastases.

• Need immediate treatment to prevent neurological deterioration.

• Prior brain radiotherapy or surgery for current brain metastases.

• Radiosensitive primary tumors such as small cell lung cancer, germ cell tumors, lymphoma, leukemia or multiple myeloma.

• Absolute neutrophil count (ANC)<1500/mm3 or platelets <50,000/mms.

• Brain metastasis diameter greater than 5 cm.

• Not pregnant or nursing

• More than 3 weeks since prior chemotherapy.

• No evidence of ischemia on EKG and/or reduced cardiac ejection fraction (i.e., < 50%) on ECHO.

• No known sensitivity or allergy to bendamustine hydrochloride or mannitol

• No more than 3 prior cytotoxic chemotherapy regimens

• No unresolved persistent toxicities for 4 weeks from prior chemotherapy or 6 weeks for nitrosoureas.

• Calculated creatinine clearance <40 ml/min.