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

This study is currently recruiting participants.
Verified August 2013 by Rutgers, The State University of New Jersey
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry New Jersey )
ClinicalTrials.gov Identifier:
NCT01018836
First received: November 24, 2009
Last updated: August 23, 2013
Last verified: August 2013
  Purpose

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

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • Maximum tolerated dose of riluzole [ Time Frame: 2.5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Long-term toxicity of riluzole [ Time Frame: .25 years ] [ Designated as safety issue: Yes ]
  • Neurocognitive function before and after treatment [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
  • MRI response of brain metastasis after treatment [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
  • Survival [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
  • Response of brain metastasis to treatment as a function of the expression of glutamate receptors [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 18
Study Start Date: November 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01018836

Locations
United States, New Jersey
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School Recruiting
New Brunswick, New Jersey, United States, 08903
Contact: Clinical Trials Office - Cancer Institute of New Jersey    732-235-8675      
Sponsors and Collaborators
University of Medicine and Dentistry New Jersey
Investigators
Principal Investigator: Bruce G. Haffty, MD Rutgers Cancer Institute of New Jersey
  More Information

Additional Information:
No publications provided

Responsible Party: Rutgers, The State University of New Jersey ( University of Medicine and Dentistry New Jersey )
ClinicalTrials.gov Identifier: NCT01018836     History of Changes
Other Study ID Numbers: 050808, CDR0000660044, P30CA072720
Study First Received: November 24, 2009
Last Updated: August 23, 2013
Health Authority: United States: Food and Drug Administration

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
Neoplasms
Neoplasms, Second Primary
Neoplastic Processes
Pathologic Processes
Riluzole
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants

ClinicalTrials.gov processed this record on April 17, 2014