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PPX and Concurrent Radiation for Newly Diagnosed Glioblastoma Without MGMT Methylation

NCT01402063 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2020-02-17

Study results available
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Summary

To obtain preliminary data in a randomized phase II study whether PPX/RT improves progression-free survival as compared to temozolomide/RT for patients with GBM without MGMT methylation.

Conditions

Interventions

DRUG

PPX (CT2103)

XRT: 60 Gy at 2 Gy/fraction x 30 fractions PPX: 50 mg/m2/week x 6 weeks during radiation Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum.

DRUG

Temozolomide

XRT: 60 Gy at 2 Gy/fraction x 30 fractions Temozolomide, 75 mg/m2/day, 7 days per week, from the first to the last day of radiotherapy Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum

Sponsors & Collaborators

  • Rhode Island Hospital

    collaborator OTHER

  • Milton S. Hershey Medical Center

    collaborator OTHER

  • University of Washington

    collaborator OTHER

  • University of Massachusetts, Worcester

    collaborator OTHER

  • MaineHealth

    collaborator OTHER

  • University of California, San Diego

    collaborator OTHER

  • Thomas Jefferson University

    collaborator OTHER

  • Brown University

    lead OTHER

Principal Investigators

  • Howard Safran, MD · BrUOG

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2014-04-30
Completion
2015-06-30

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 NCT01402063 on ClinicalTrials.gov