Physician VersionPatient Version

Protocol No.Principal InvestigatorPhaseAge GroupScopeSecondary Protocol No.Status
OSU-08142Grecula, JohnIAdultLocalOpen

Adapted from the National Cancer Institute's Physician Data Query (PDQ®) Cancer Clinical Trials (http://www.cancer.gov/clinicaltrials)

Title

Phase I Study of Bendamustine and Fractionated Stereotactic Radiotherapy of Patients With 1- 4 Brain Metastases From Solid Malignancies
Bendamustine and Radiation Therapy in Treating Patients With Brain Metastases Caused by Solid Tumors

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.

To view the NCI PDQ information for this trial, click here

To view the clinicaltrials.gov information for this trial, click here

Detailed Description/Objectives

OBJECTIVES:

Primary

Secondary

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.

Eligibility

Inclusion Criteria:

Exclusion Criteria:

Applicable Disease Sites

Brain and Central Nervous System

Participating Institutions

James Cancer Hospital
Martha Morehouse

Contact

Jill Brown
Phone:614-293-5554
Email:jill.brown@osumc.edu