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S0001 RT and Carmustine With or Without O6BG in Patients With New Glioblastoma Multiforme or Gliosarcoma

NCT00017147 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 183

Last updated 2013-01-30

No results posted yet for this study

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. O6-benzylguanine may help carmustine kill more tumor cells by making tumor cells more sensitive to the drug. It is not yet known whether radiation therapy and carmustine are more effective with or without O6-benzylguanine.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy plus carmustine with or without O6-benzylguanine in treating patients who have newly diagnosed glioblastoma multiforme or gliosarcoma.

Conditions

  • Malignant Neoplasms of Eye, Brain and Other Parts of Central Nervous System

Interventions

DRUG

carmustine

40 mg/m\^2 IV over 1 hour on day 1 of each cycle 6 hours after O6-BG dose for experimental arm with O6=BG. 200 mg/m\^2 IV over 1 hour on day 2 of each cycle for the active comparator arm.

RADIATION

radiation therapy

5 days/week using one fraction per day and a dose of 180 cGy per fraction. Initial target volume is dose of 5040 cGy in 28 fractions with boost target volume of 1080 cGy in 6 fractions.

DRUG

O6-Benzylguanine

120 mg/m\^2 IV over 1 hour on day 1 of each cycle

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • SWOG Cancer Research Network

    lead NETWORK

Principal Investigators

  • Deborah T. Blumenthal, MD · University of Utah

  • Alexander M. Spence, MD · University of Washington

  • Keith J. Stelzer, MD, PhD · Celilo Cancer Center at Mid-Columbia Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-09-30
Primary Completion
2006-05-31
Completion
2012-11-30

Countries

  • United States

Study Locations

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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 NCT00017147 on ClinicalTrials.gov