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

NCT ID: NCT01018836

Last Updated: 2014-05-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2013-12-31

Brief 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.

Detailed 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.

Conditions

Metastatic Cancer; Unspecified Adult Solid Tumor, Protocol Specific

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Riluzole; Radiation Therapy

Group Type: EXPERIMENTAL

riluzole

Intervention Type: DRUG

The first dose of Riluzole will be day 0 of study enrollment. WBRT must begin within 48 hours of the initiation of Riluzole therapy. At the completion of radiation, Riluzole should be discontinued and steroids should be tapered over the course of 1-3 weeks, at the discretion of the treating physicians.

whole-brain radiation therapy

Intervention Type: RADIATION

Standard whole brain irradiation will be carried out at 250 cGy per day fractions times 15 to a total dose of 3750 cGy using a standard opposed lateral helmet field with the inferior border inclusive of C1.

Interventions

riluzole

The first dose of Riluzole will be day 0 of study enrollment. WBRT must begin within 48 hours of the initiation of Riluzole therapy. At the completion of radiation, Riluzole should be discontinued and steroids should be tapered over the course of 1-3 weeks, at the discretion of the treating physicians.

Intervention Type: DRUG

whole-brain radiation therapy

Standard whole brain irradiation will be carried out at 250 cGy per day fractions times 15 to a total dose of 3750 cGy using a standard opposed lateral helmet field with the inferior border inclusive of C1.

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Rutgers, The State University of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bruce G. Haffty, MD

Role: PRINCIPAL_INVESTIGATOR

Rutgers Cancer Institute of New Jersey

Locations

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

New Brunswick, New Jersey, United States

Countries

United States

Other Identifiers

CDR0000660044

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA072720

Identifier Type: NIH

Identifier Source: secondary_id

View Link

050808

Identifier Type: -

Identifier Source: org_study_id