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Glioblastoma Multiforme (GBM) Locoregional Agent Survival Study - Anti-tenascin Radiolabeled Antibody Therapy

NCT00615186 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2011-02-10

No results posted yet for this study

Summary

The current study will investigate whether the addition of Neuradiab to surgery, radiation and adjuvant chemotherapy (temozolomide) will improve the survival of patients with glioblastoma and whether the drug regimen is safe.

Conditions

Interventions

DRUG

Neuradiab + Radiotherapy + Temozolomide

Prior Surgery Rickham Catheter placement 99mTc-DTPA Flow Study Neuradiab Dosimetry Study Neuradiab Therapeutic Dose Administration Radiation Therapy (XRT) + Temozolomide: XRT 5 days/week + temozolomide (75 mg/m2/day) over 6.5 weeks. Post-Radiation Temozolomide Therapy: Temozolomide 150-200 mg/m2/day × 5 days, every 28 days until patient's death, confirmed disease progression, unacceptable toxicity, non-compliance with the protocol, withdrawal of consent, and/or other factor that in the opinion of the consulting oncologist precludes continued study treatment.

DRUG

Radiation Therapy + Temozolomide

Prior Surgery: Gross total resection (\< 1 cm. enhancing rim) Radiation Therapy (XRT) + Temozolomide: XRT 5 days/week + 42 days of temozolomide (75 mg/m2/day) over 6.5 weeks Post-Radiation Temozolomide Therapy: Temozolomide 150-200 mg/m2/day × 5 days, every 28 days until patient's death, confirmed disease progression, unacceptable toxicity, non-compliance with the protocol, withdrawal of consent, and/or other factor that in the opinion of the consulting oncologist precludes continued study treatment.

Sponsors & Collaborators

  • Bradmer Pharmaceuticals Inc.

    lead INDUSTRY

Principal Investigators

  • David A. Reardon, MD · Duke University

  • Philip J Bierman, MD · University of Nebraska

  • Ray M. Chu, MD · Cedars-Sinai Medical Center

  • Susan C. Pannullo, MD · New York Presbyterian - Cornell

  • Frank D. Vrionis, MD, MPH, PhD · Moffitt Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2013-08-31
Completion
2013-12-31

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Diseases

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 NCT00615186 on ClinicalTrials.gov