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CT-322 in Combination With Radiation Therapy and Temozolomide to Treat Newly Diagnosed Glioblastoma Multiforme

NCT00768911 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2010-10-27

No results posted yet for this study

Summary

Rationale:

In light of the demonstrated activity of anti-angiogenesis agents in rGBM, it is reasonable to postulate that adding these agents to standard RT and chemotherapy in the up-front management of newly diagnosed GBM may improve the clinical benefit. This study will examine the safety and tolerability of adding CT-322 to the standard radiation therapy/temozolomide (RT/TMZ) backbone of treatment for newly diagnosed GBM

Conditions

Interventions

DRUG

CT-322

Intravenous solution, intravenous administration, starting dose level of 0.5 mg/kg/week Dose levels: 0.5 mg/kg/week, 1.0 mg/kg/week, 2.0 mg/kg/week

DRUG

Temozolomide

75 mg/M2/day p.o. continuously 7 days per week during concurrent RT (max: 49 days) 150 mg/M2/day X 5 days; adjuvant cycle #1 200 mg/M2/day X 5 days; subsequent adjuvant cycles (# 2-12) if tolerability criteria met

PROCEDURE

Radiation Therapy

RT will consist of fractionated focal irradiation administered using 2 Gy/fraction, QD x 5 days/week for 6 weeks, for a total dose of 60 Gy

Sponsors & Collaborators

  • Adnexus, A Bristol-Myers Squibb R&D Company

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2010-10-31
Completion
2011-06-30

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT00768911 on ClinicalTrials.gov