Riluzole and Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases
This study is currently recruiting participants.
Verified June 2012 by University of Medicine and Dentistry New Jersey
Sponsor:
University of Medicine and Dentistry New Jersey
Collaborator:
Information provided by (Responsible Party):
University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier:
NCT01018836
First received: November 24, 2009
Last updated: June 12, 2012
Last verified: June 2012
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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: | Allocation: Non-Randomized 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 University of Medicine and Dentistry 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 Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: riluzole
The first dose of Riluzule will be day 0 of study enrollment. WBRT must begin within 48 hours of the initiation of Riluzole therapy. At the completion of radiaton, 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.
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 | Cancer Institute of New Jersey |
More Information
Additional Information:
No publications provided
| Responsible Party: | 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: | June 12, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Medicine and Dentistry 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 May 21, 2013