CT-322 in Treating Patients With Recurrent Glioblastoma Multiforme and Combination Therapy With Irinotecan

Phase 2

• Conditions: Brain and Central Nervous System Tumors; Recurrent Glioblastoma Multiforme
• Interventions: Drug: CT-322; Drug: irinotecan hydrochloride

• Registration Number: NCT00562419
• Lead Sponsor: Adnexus, A Bristol-Myers Squibb R&D Company

Brief Summary

RATIONALE: CT-322 may stop the growth of glioblastoma multiforme by blocking blood flow to the tumor. Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving CT-322 together with irinotecan may kill more tumor cells.

PURPOSE: This phase 2 trial is studying the side effects, tolerability, and efficacy of CT-322 when given alone and in combination with irinotecan to patients with glioblastoma multiforme.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-11-20
• Study First Submitted QC: 2007-11-20
• Study First Posted: 2007-11-22
• Status Verified: 2010-10
• Last Update Submitted: 2010-10-26
• Last Update Posted: 2010-10-27
• Primary Completion: 2011-06
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	CT-322	CT-322
2	CT-322	CT-322 and irinotecan hydrochloride
2	irinotecan hydrochloride	CT-322 and irinotecan hydrochloride

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of CT-322 when administered alone or in combination with irinotecan hydrochloride (Part 1)	15 ± 5 days post the last dose of study drug
Progression-free survival at 6 months (Part 2)	Measured upon initiation of cycles 2, 3, 5, 7, 9, 11, and end of study

Secondary Outcome Measures

Name	Time	Method
To assess the plasma pharmacokinetics of CT-322 (Cmax, Tmax, AUC, T-HALF) derived from plasma concentration vs time for CT-322 given alone and in combination with irinotecan	Part 1: cycle 1, days 1-3, day 5 or 6, days 8, 15, and 22; cycles 2-4, 6, 9, and 12, day 1; EOS and follow up visits. Part 2: cycle 1, days 1, 8, 15, and 22; cycles 2-4, 6, 9, and 12, day 1; EOS and follow up visits.
To assess the presence of anti CT-322 antibodies	Part 1: cycle 1, days 1 and 15; cycles 2-4, 6, 9, and 12, day 1; EOS and follow up visits. Part 2: cycle 1, days 1 and 15; cycles 2-4, 6, 9, and 12, day 1; EOS and follow up visits.
To assess the biological activity of CT-322 as measured by plasma biological markers and neuroimaging	Part 1: cycle 1, days 1, 2, 8, 15 and 22; cycles 2-4, 6, 9, and 12, day 1; EOS visit. Part 2: cycle 1, days 1, 8, 15 and 22; cycles 2-4, 6, 9, and 12 EOS visit.

Trial Locations

Locations (10)

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

University of California, San Diego; 🇺🇸 La Jolla, California, United States

Henry Ford Health System; 🇺🇸 Detroit, Michigan, United States

SUNY Upstate Medical University; 🇺🇸 Syracuse, New York, United States

University of Virgina; 🇺🇸 Charlottesville, Virginia, United States

University of Wisconsin Hospital; 🇺🇸 Madison, Wisconsin, United States

Rhode Island Hospital; 🇺🇸 Providence, Rhode Island, United States