Clinical trial · Interventional
Riluzole and Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases
A Phase I Trial of Riluzole in Combination With Radiation Therapy in Patients Undergoing Whole Brain Radiation Therapy for Brain Metastasis
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow accrual
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| riluzole | Drug | — | UNRESOLVED |
| whole-brain radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Riluzole; Radiation Therapy
- interventionNames
- Drug: riluzole
- Radiation: whole-brain radiation therapy
Primary outcomes (1)
- measure
- Maximum tolerated dose of riluzole
- timeFrame
- 2.5 years
Secondary outcomes (5)
- measure
- Long-term toxicity of riluzole
- timeFrame
- .25 years
- measure
- Neurocognitive function before and after treatment
- timeFrame
- 2.5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available