Riluzole and Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases

• Status: Terminated
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. Drugs, such as riluzole, may make tumor cells more sensitive to radiation therapy. Giving riluzole together with whole-brain radiation therapy may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of riluzole when given together with whole-brain radiation therapy in treating patients with brain metastases.

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

Details

• Lead Sponsor: Rutgers, The State University of New Jersey
• Collaborator: National Cancer Institute (NCI)
• Treatments: Riluzole

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed solid tumor

• Has ≥ 2 brain metastases as demonstrated by baseline MRI

• Patients with only 1 metastasis are eligible provided the metastasis is too large for radiosurgery and not amenable to surgical resection

• Not being considered for surgical resection

• Eligible to undergo whole-brain radiotherapy (WBRT)

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• ANC ≥ 1,000/μL

• Platelet count ≥ 50,000/μL

• Total bilirubin ≤ 1.5 times upper limit of normal (ULN)

• AST/ALT ≤ 1.5 times ULN

• INR ≤ 1.5 times ULN

• Sodium normal

• Thyroid-stimulating hormone normal

• Negative pregnancy test

• Fertile patients must use effective contraception before, during, and for ≥ 6 months after completion of study treatment

• No headaches, disequilibrium, vertigo, or dizziness

• No known history of hepatitis B or C

• No concurrent serious systemic disorder (including active infection) that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator

• No history of allergic reactions attributed to riluzole

PRIOR CONCURRENT THERAPY:

• No prior WBRT

• At least 2 weeks since prior systemic chemotherapy

• No systemic chemotherapy during and for ≥ 3 weeks after completion of WBRT

• Radiosurgical boosts to ≤ 3 metastases allowed, based on the discretion of the treating radiation oncologist