NCT00768911

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

Phase 1, Open Label, Multi-Center Study To Evaluate The Safety And Tolerability of CT-322 Administered In Combination With Focal Brain Radiotherapy And Temozolomide To Subjects With Newly Diagnosed Glioblastoma Multiforme

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Adnexus, A Bristol-Myers Squibb R&D Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Glioblastoma Multiforme

Interventions

Type	Name	Description
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

Timeline

• Start date: 2008-10-01
• Primary completion: 2010-10-01
• Completion: 2011-06-01
• First posted: 2008-10-08
• Last updated: 2010-10-27

Locations

6 sites across 1 country: United States