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

NCT01018836 | Terminated Phase 1

• 3 other identifiers: 050808CDR0000660044P30CA072720
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Cancer; Unspecified Adult Solid Tumor, Protocol Specific

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose of riluzole

  2.5 years

Secondary Outcomes (5)

• Long-term toxicity of riluzole

  .25 years

• Neurocognitive function before and after treatment

  2.5 years

• MRI response of brain metastasis after treatment

  2.5 years

• Survival

  2.5 years

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

  2.5 years

Study Arms (1)

Riluzole; Radiation Therapy

EXPERIMENTAL

Drug: riluzole; Radiation: whole-brain radiation therapy

Interventions

riluzole DRUG

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.

Riluzole; Radiation Therapy

whole-brain radiation therapy RADIATION

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.

Riluzole; Radiation Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

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

New Brunswick, New Jersey, 08903, United States

Location

MeSH Terms

Conditions

Neoplasm Metastasis; Brain Neoplasms

Interventions

Riluzole

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Benzothiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Bruce G. Haffty, MD

  Rutgers Cancer Institute of New Jersey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2009
• First Posted: November 25, 2009
• Study Start: November 1, 2009
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: May 2, 2014

Record last verified: 2014-04

Locations

US (1)