Clinical trial · Interventional
Ph I Study of Lithium During Whole Brain Radiotherapy For Patients With Brain Metastases
A Phase I Study of Lithium During Whole Brain Radiotherapy for Patients With Brain Metastases
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): low accrual
Summary
Brief summary (as posted)
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs, such as lithium, may protect normal cells from the side effects of radiation therapy. Giving lithium together with radiation therapy may allow a higher dose of radiation therapy to be given so that more tumor cells are killed. PURPOSE: This phase I trial is studying the side effects and best dose of lithium when given together with whole-brain radiation therapy in treating patients with brain metastases from primary cancer outside the brain.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
| Cognitive/Functional Effects | — | UNRESOLVED | — |
| Neurotoxicity | — | UNRESOLVED | — |
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cognitive assessment | Procedure | — | UNRESOLVED |
| lithium carbonate | Drug | — | UNRESOLVED |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Therapeutic Intervention
- interventionNames
- Drug: lithium carbonate
- Procedure: cognitive assessment
- Procedure: quality-of-life assessment
- Radiation: radiation therapy
Primary outcomes (1)
- measure
- Feasibility of concurrent lithium carbonate and whole-brain radiotherapy as measured by safety and compliance
- timeFrame
- Safety is measured by the rate of grade 3 or worse
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histopathologically confirmed extracranial primary malignancy * Multiple (i.e., \> 3) brain metastases OR \< 3 metastases with at least 1 metastasis \> 4.0 cm in diameter * Not eligible for radiosurgery * No requirement for immediate whole-brain radiotherapy * No metastases to the midbrain or brainstem Exclusion Criteria: * Zubrod performance status 0-2 * Life expectancy ≥ 8 weeks * Platelet count \> 100,000/mm\^3 * ANC \> 1,500/mm\^3 * Hemoglobin ≥ 10 g/dL * BUN \< 25 mg/dL * Creatinine \< 1.5 mg/dL * Bilirubin \< 1.5 mg/dL * ALT ≤ 2 times normal * Sodium \> 136 mg/dL * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Neurologically stable * No seizure disorders or seizures due to brain metastases * No medical illnesses or psychiatric conditions that would preclude completion of study treatment * No sensory neuropathy ≥ grade 2 * No bipolar disorder * No thyroid disease * No QTc interval prolongation PRIOR CONCURRENT THERAPY: * More than 2 weeks since prior and no concurrent chemotherapy * At least 2 weeks since prior and no concurrent NSAIDs, angiotensin-converting enzyme inhibitors (e.g., enalapril or captopril), calcium channel blockers, diuretics, selective cyclooxygenase-2 inhibitors, acetazolamide, urea, xanthine, or alkalinizing agents (e.g., sodium bicarbonate) * No prior radiotherapy to the head and neck area * No prior radiosurgery * No concurrent radiotherapy to other sites * No concurrent anticonvulsants due to brain metastases * No concurrent psychoactive drugs * No concurrent thyroid medications * No concurrent amifostine
References
Publications (0)
Data not yet available