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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01018836
Recruitment Status : Terminated (Slow accrual)
First Posted : November 25, 2009
Last Update Posted : May 2, 2014
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey

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.

Condition or disease Intervention/treatment Phase
Metastatic Cancer Unspecified Adult Solid Tumor, Protocol Specific Drug: riluzole Radiation: whole-brain radiation therapy Phase 1

Detailed Description:



  • 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 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Trial of Riluzole in Combination With Radiation Therapy in Patients Undergoing Whole Brain Radiation Therapy for Brain Metastasis
Study Start Date : November 2009
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Riluzole
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Riluzole; Radiation Therapy Drug: 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.
Radiation: 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.

Primary Outcome Measures :
  1. Maximum tolerated dose of riluzole [ Time Frame: 2.5 years ]

Secondary Outcome Measures :
  1. Long-term toxicity of riluzole [ Time Frame: .25 years ]
  2. Neurocognitive function before and after treatment [ Time Frame: 2.5 years ]
  3. MRI response of brain metastasis after treatment [ Time Frame: 2.5 years ]
  4. Survival [ Time Frame: 2.5 years ]
  5. Response of brain metastasis to treatment as a function of the expression of glutamate receptors [ Time Frame: 2.5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01018836

United States, New Jersey
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
Sponsors and Collaborators
Rutgers, The State University of New Jersey
National Cancer Institute (NCI)
Principal Investigator: Bruce G. Haffty, MD Rutgers Cancer Institute of New Jersey

Responsible Party: Rutgers, The State University of New Jersey Identifier: NCT01018836     History of Changes
Other Study ID Numbers: 050808
CDR0000660044 ( Other Identifier: NIH )
P30CA072720 ( U.S. NIH Grant/Contract )
First Posted: November 25, 2009    Key Record Dates
Last Update Posted: May 2, 2014
Last Verified: April 2014

Keywords provided by Rutgers, The State University of New Jersey:
tumors metastatic to brain
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents