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

NCT ID: NCT00509301

Last Updated: 2011-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2010-03-31

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.

Conditions

Recurrent Glioblastoma Multiforme

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

1.5 mCi/cc

Group Type: EXPERIMENTAL

131-I-chTNT-1/B MAB

Intervention Type: DRUG

The study drug is given interstitially for approximately 25 hours at a dose of 1.5, 2.0, or 2.5 mCi/cc.

2

2.0 mCi/cc

Group Type: EXPERIMENTAL

131-I-chTNT-1/B MAB

Intervention Type: DRUG

The study drug is given interstitially for approximately 25 hours at a dose of 1.5, 2.0, or 2.5 mCi/cc.

3

2.5 mCi/cc

Group Type: EXPERIMENTAL

131-I-chTNT-1/B MAB

Intervention Type: DRUG

The study drug is given interstitially for approximately 25 hours at a dose of 1.5, 2.0, or 2.5 mCi/cc.

Interventions

131-I-chTNT-1/B MAB

The study drug is given interstitially for approximately 25 hours at a dose of 1.5, 2.0, or 2.5 mCi/cc.

Intervention Type: DRUG

Other Intervention Names

Cotara

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peregrine Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Peregrine Pharmaceuticals

Principal Investigators

Sunil J Patel, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Kenneth M Spicer, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Kevin D Judy, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

William R Shapiro, MD

Role: PRINCIPAL_INVESTIGATOR

Barrow Neurological Institute

Andrew E Sloan, MD, FACS

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center

Locations

Barrow Neurological Institute

Phoenix, Arizona, United States

University Hospitals Case Medical Center

Cleveland, Ohio, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

Other Identifiers

PPHM 0602

Identifier Type: -

Identifier Source: org_study_id

NCT00516789

Identifier Type: -

Identifier Source: nct_alias