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Bendamustine and Radiation Therapy in Treating Patients With Brain Metastases Caused by Solid Tumors

NCT00837928 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2018-05-17

No results posted yet for this study

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.

Conditions

Interventions

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)

Sponsors & Collaborators

Principal Investigators

  • John C. Grecula, MD · Ohio State University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-19
Primary Completion
2015-01-08
Completion
2015-01-08

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00837928 on ClinicalTrials.gov