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Phase I Portion of Phase I/II Sorafenib With Radiation and Temozolomide in Newly Diagnosed Glioblastoma or Gliosarcoma

NCT00734526 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2018-11-09

No results posted yet for this study

Summary

The goal of this clinical research study is to find the highest tolerable dose of sorafenib that can be given in combination with temozolomide. The safety of this combination will also be studied.

Conditions

Interventions

DRUG

Temozolomide

Groups 1 \& 2: 75 mg/m\^2 Once Daily by Mouth During Radiation; 4 Weeks after Completion of Radiation, 150-200 mg/m\^2 Once Daily by Mouth Days 1-5 of 1st 28-Day Cycle, then 75 mg/m\^2 Once Daily by Mouth Days 1-5 for Subsequent 28-Day Cycles. Groups 3 \& 4: 75 mg/m\^2 Once Daily by Mouth During Radiation; 4 Weeks after Completion of Radiation, 75-100 mg/m\^2 Once Daily by Mouth Days 1-21 every 28-Day Cycle.

RADIATION

Radiation

Total of 60 Gy delivered over 30 Days (approximately 6 weeks).

DRUG

Sorafenib

Group 1: 4 Weeks after Completion of Radiation, 400 mg Twice Daily by Mouth. Group 2: 200 mg Twice Daily by Mouth during Radiation; 4 Weeks after Completion of Radiation, 400 mg Twice Daily by Mouth. Group 3: 200 mg Twice Daily by Mouth during Radiation; 4 Weeks after Completion of Radiation, 200 mg Twice Daily by Mouth. Group 4: 400 mg Twice Daily by Mouth during Radiation; 4 Weeks after Completion of Radiation, 400 mg Twice Daily by Mouth.

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Vinay K. Puduvalli, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-18
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • United States

Study Locations

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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 NCT00734526 on ClinicalTrials.gov