Safety & Radiation Distribution Study of Cotara® in Patients With Recurrent Glioblastoma Multiforme

Phase 1

Completed

• Conditions: Recurrent Glioblastoma Multiforme
• Interventions: Drug: 131-I-chTNT-1/B MAB

• Registration Number: NCT00509301
• Lead Sponsor: Peregrine Pharmaceuticals

Brief Summary

RATIONALE: Cotara® is an experimental new treatment that links a radioactive isotope (iodine 131) to a targeted monoclonal antibody. This monoclonal antibody is designed to bind tumor cells and deliver radiation directly to the center of the tumor mass while minimizing effects on normal tissues. Cotara® thus literally destroys the tumor "from the inside out." This may be an effective treatment for glioblastoma multiforme, a malignant type of brain cancer.

PURPOSE: This trial is studying the safety and radiation distribution of Cotara® in patients with recurrent glioblastoma multiforme.

Detailed Description

OBJECTIVES:

Primary

* To confirm the dose limiting toxicities (DLT) and maximum tolerated dose (MTD) of 131I-chTNT-1/B MAb (Cotara®) when given as a single 25 hour interstitial infusion in patients with recurrent GBM

* To characterize the biodistribution and radiation dosimetry of Cotara®

OUTLINE:

This is an open-label, dose escalation study of Cotara®.

All patients will receive 3 mCi of Cotara® for biodistribution and radiation dosimetry purposes. In addition, patients will receive escalating therapeutic dose levels of Cotara® for confirmation of the maximum tolerated dose (MTD). After completion of study treatment, patients are followed for a minimum of 12 weeks and until disease progression.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2007-07-27
• Study First Submitted QC: 2007-07-27
• Study First Posted: 2007-07-31
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-03
• Last Update Posted: 2011-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Patients with recurrent GBM
• Patients with a Clinical Target Volume between 5 and 60 cc (inclusive)
• Patients of 18 years of age or older
• Karnofsky Performance Status ≥ 60 at screening
• Patients not on steroids or maintained on a stable corticosteroid regimen (± 4 mg) for at least 2 weeks prior to study entry

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Exclusion Criteria

• Patients with infratentorial tumor(s), exophytic intra-ventricular tumor(s) or subependymal tumor spread extending greater than 2 cm
• Patients with diffuse disease
• Patients with known or suspected allergy to study medication or iodine
• Patients who received investigational agents within 30 days prior to baseline
• Patients who received surgical resection within 4 weeks from baseline
• Patients with known HIV or evidence of active hepatitis
• Patients who cannot undergo MRI

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	131-I-chTNT-1/B MAB	1.5 mCi/cc
2	131-I-chTNT-1/B MAB	2.0 mCi/cc
3	131-I-chTNT-1/B MAB	2.5 mCi/cc

Primary Outcome Measures

Name	Time	Method
To confirm dose limit and maximum tolerated dose and to characterize radiation distribution

Trial Locations

Locations (4)

Barrow Neurological Institute; 🇺🇸 Phoenix, Arizona, United States

University Hospitals Case Medical Center; 🇺🇸 Cleveland, Ohio, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States