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

Rutgers The State University of New Jersey

Status and phase

Terminated

Phase 1

Conditions

Metastatic Cancer

Unspecified Adult Solid Tumor, Protocol Specific

Treatments

Drug: riluzole

Radiation: whole-brain radiation therapy

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01018836

P30CA072720 (U.S. NIH Grant/Contract)

050808

CDR0000660044 (Other Identifier)

Details and patient eligibility

About

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.

Full description

OBJECTIVES:

Primary

To determine the maximum tolerated dose of riluzole that can be administered concurrently with standard whole-brain radiotherapy (WBRT) in patients with multiple brain metastases.

Secondary

To determine the long-term toxicity of riluzole when administered with WBRT.
To assess neurocognitive function before and after treatment with riluzole and WBRT.
To determine the MRI response of brain metastasis after treatment with riluzole and WBRT.
To compare survival of patients treated with riluzole and WBRT to published historical data for patients with brain metastases.
To evaluate the response of brain metastasis to riluzole and WBRT as a function of the expression of glutamate receptors on the primary tumor specimen.

OUTLINE: This is a dose-escalation study of riluzole.

Patients receive oral riluzole twice daily beginning on day 0. Beginning within 2 days after the initiation of riluzole, patients undergo whole-brain radiotherapy for 15 fractions.

Patients undergo neurocognitive and quality-of-life assessments at baseline, at 5 weeks, and at 3 months.

Tumor tissue samples are collected for laboratory biomarker studies.

After completion of study treatment, patients are followed up at 6 weeks, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Enrollment

9 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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