Clinical trial · Interventional
Bendamustine and Radiation Therapy in Treating Patients With Brain Metastases Caused by Solid Tumors
Phase I Study of Bendamustine and Fractionated Stereotactic Radiotherapy of Patients With 1- 4 Brain Metastases From Solid Malignancies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as bendamustine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. PURPOSE: This phase I trial is studying the side effects and best dose of bendamustine when given together with radiation therapy in treating patients with brain metastases caused by solid tumors.
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bendamustine | Drug | Bendamustine | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| Stereotactic body radiation therapy | Radiation | — | UNRESOLVED |
| Surgical Resection of Brain Metastases | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Bendamustine and Fractionated stereotactic radiotherapy
- description
- Bendamustine 40 mg/m2 and will be administered IV on days 1,2,and 3 prior to surgery on each day of SRT (Sterotactic radiation therapy). Laboratory biomarker analysis will be obtained on day 1 or 2 only from patients undergoing surgery on day 3 (i.e. Pharmacokinetic samples will not be collected from patients who begin SRT on day 1). Surgical Resection of Brain Metastases Day 3 (immediately after Bendamustine) Stereotactic fractionated radiation therapy starting at least 4 weeks after surgery (Day 1 if no surgery ); 30 Gy in 5 daily fractions(Mon-Fri). Concurrent Bendamustine is administered on Days of Stereotactic Radiotherapy (Arm 1: 40 mg/m2/ Day; Arm 2: 50 mg/m2/day).
- interventionNames
- Drug: bendamustine
- Other: laboratory biomarker analysis
- Procedure: Surgical Resection of Brain Metastases
- Radiation: Stereotactic body radiation therapy
Primary outcomes (1)
- measure
- Determine recommended dose of Bendamustine when used in combination with Stereotactic Radiotherapy (STR) for treatment of patients with 1-4 brain metastases.
- timeFrame
- up to 4 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed cancer with 1 to 4 brain metastases imaged by MRI/CT scans not involving thalamus, basal ganglia or brain stem. * No cancer originating in central nervous system * Candidate for clinically indicated surgery to resect brain lesions. * Karnofsky score of at least 60 * At least 18 years of age * Life expectancy of more than two months Exclusion Criteria: * Evidence of leptomeningeal metastases. * Need immediate treatment to prevent neurological deterioration. * Prior brain radiotherapy or surgery for current brain metastases. * Radiosensitive primary tumors such as small cell lung cancer, germ cell tumors, lymphoma, leukemia or multiple myeloma. * Absolute neutrophil count (ANC)\<1500/mm3 or platelets \<50,000/mms. * Brain metastasis diameter greater than 5 cm. * Not pregnant or nursing * More than 3 weeks since prior chemotherapy. * No evidence of ischemia on EKG and/or reduced cardiac ejection fraction (i.e., \< 50%) on ECHO. * No known sensitivity or allergy to bendamustine hydrochloride or mannitol * No more than 3 prior cytotoxic chemotherapy regimens * No unresolved persistent toxicities for 4 weeks from prior chemotherapy or 6 weeks for nitrosoureas. * Calculated creatinine clearance \<40 ml/min.
References
Publications (0)
Data not yet available