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A Phase I Trial of Riluzole in Combination With Radiation Therapy in Patients Undergoing Whole Brain Radiation Therapy for Brain Metastasis

Phase 1
18 Years
Open (Enrolling)
Metastatic Cancer, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

A Phase I Trial of Riluzole in Combination With Radiation Therapy in Patients Undergoing Whole Brain Radiation Therapy for Brain Metastasis



- 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.


- 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

- 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.

Inclusion Criteria


- 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)


- 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


- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose of riluzole

Outcome Time Frame:

2.5 years

Safety Issue:


Principal Investigator

Bruce G. Haffty, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Institute of New Jersey


United States: Food and Drug Administration

Study ID:




Start Date:

November 2009

Completion Date:

Related Keywords:

  • Metastatic Cancer
  • Unspecified Adult Solid Tumor, Protocol Specific
  • tumors metastatic to brain
  • unspecified adult solid tumor, protocol specific
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary



Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School New Brunswick, New Jersey  08903