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

Primary Purpose

Metastatic Cancer, Unspecified Adult Solid Tumor, Protocol Specific

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

riluzole

whole-brain radiation therapy

About this trial

This is an interventional treatment trial for Metastatic Cancer focused on measuring tumors metastatic to brain, unspecified adult solid tumor, protocol specific

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Riluzole; Radiation Therapy

Arm Description

Outcomes

Primary Outcome Measures

Maximum tolerated dose of riluzole

Secondary Outcome Measures

Long-term toxicity of riluzole

Neurocognitive function before and after treatment

MRI response of brain metastasis after treatment

Survival

Response of brain metastasis to treatment as a function of the expression of glutamate receptors

Full Information

NCT ID

NCT01018836

First Posted

November 24, 2009

Last Updated

April 30, 2014

Sponsor

Rutgers, The State University of New Jersey

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT01018836

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2014

Overall Recruitment Status

Terminated

Why Stopped

Slow accrual

Study Start Date

November 2009 (undefined)

Primary Completion Date

December 2013 (Actual)

Study Completion Date

December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Rutgers, The State University of New Jersey

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastatic Cancer, Unspecified Adult Solid Tumor, Protocol Specific

Keywords

tumors metastatic to brain, unspecified adult solid tumor, protocol specific

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Riluzole; Radiation Therapy

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

riluzole

Intervention Description

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

Radiation

Intervention Name(s)

whole-brain radiation therapy

Intervention Description

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 Measure Information:

Title

Maximum tolerated dose of riluzole

Time Frame

2.5 years

Secondary Outcome Measure Information:

Title

Long-term toxicity of riluzole

Time Frame

.25 years

Title

Neurocognitive function before and after treatment

Time Frame

2.5 years

Title

MRI response of brain metastasis after treatment

Time Frame

2.5 years

Title

Survival

Time Frame

2.5 years

Title

Response of brain metastasis to treatment as a function of the expression of glutamate receptors

Time Frame

2.5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bruce G. Haffty, MD

Organizational Affiliation

Rutgers Cancer Institute of New Jersey

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

New Brunswick

State/Province

New Jersey

ZIP/Postal Code

08903

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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