NCT00837928

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: John Grecula · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: Primary * Determine the recommended phase II dose of bendamustine hydrochloride when administered in combination with stereotactic radiotherapy for the treatment of patients with 1-4 brain metastases from solid malignancies. Secondary * Determine bendamustine hydrochloride pharmacokinetics and correlate this to bendamustine hydrochloride levels in brain metastases, brain margin, arachnoid, cerebral spinal fluid, and plasma acquired at the time of surgery. * Assessment of local control of brain metastases. OUTLINE: This is a dose-escalation study of bendamustine hydrochloride. Patients with no potentially resectable lesion(s) receive bendamustine hydrochloride IV over 30 minutes and stereotactic radiotherapy once daily for 5 days. Patients with potentially resectable lesion(s) receive bendamustine hydrochloride IV over 30 minutes on days 1-3 and undergo surgery on day 3. At least 4 weeks after surgery, these patients receive adjuvant bendamustine hydrochloride and stereotactic fractionated radiotherapy as above (in patients with no potentially resectable lesion\[s\]) Blood samples are collected periodically for pharmacokinetic studies. Cerebrospinal fluid, arachnoid, tumor margin, and tumor samples are also collected during surgery for correlative studies. After completion of study treatment, patients are followed every 3 months for 21 months.

Conditions

• Metastatic Cancer
• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	bendamustine	40 mg/m2 will be administered IV on days 1,2,and 3 prior to surgery.on each day of SRT.
OTHER	laboratory biomarker analysis	samples will be obtained on day 1 or 2 only from patients undergoing surgery on day 3 (i.e. PK samples will not be collected from patients who begin SRT on day 1).
PROCEDURE	Surgical Resection of Brain Metastases	Surgical Resection of Brain Metastases Day 3 (immediately after Bendamustine)
RADIATION	Stereotactic body radiation therapy	Starting at least 4 weeks after surgery (Day 1 if no surgery ); 30 Gy in 5 daily fractions(Mon-Fri)

Timeline

• Start date: 2009-02-19
• Primary completion: 2015-01-08
• Completion: 2015-01-08
• First posted: 2009-02-06
• Last updated: 2018-05-17

Locations

1 site across 1 country: United States