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

Tracking Information

First Received Date ^ICMJE

July 27, 2007

Last Updated Date

December 2, 2009

Start Date ^ICMJE

November 2006

Estimated Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To confirm dose limit and maximum tolerated dose and to characterize radiation distribution [ Time Frame: unknown ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00509301 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Open-label Dose Confirmation and Dosimetry Study of Interstitial 131I-chTNT-1/B MAb (Cotara®) for the Treatment of Recurrent Glioblastoma Multiforme

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.

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Allocation:  Non-Randomized
Control:  Uncontrolled
Endpoint Classification:  Safety Study
Intervention Model:  Single Group Assignment
Masking:  Open Label
Primary Purpose:  Treatment

Condition ^ICMJE

Recurrent Glioblastoma Multiforme

Intervention ^ICMJE

Drug: 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.

Other Name: Cotara

Study Arms / Comparison Groups

1: Experimental
1.5 mCi/cc

Intervention: Drug: 131-I-chTNT-1/B MAB
2: Experimental
2.0 mCi/cc

Intervention: Drug: 131-I-chTNT-1/B MAB
3: Experimental
2.5 mCi/cc

Intervention: Drug: 131-I-chTNT-1/B MAB

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

March 2010

Estimated Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00509301

Responsible Party

Jennifer Lai, MBA, CCRA, Peregrine Pharmaceuticals

Study ID Numbers ^ICMJE

PPHM 0602

Study Sponsor ^ICMJE

Peregrine Pharmaceuticals

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:	Sunil J Patel, MD	Medical University of South Carolina
Principal Investigator:	Kenneth M Spicer, MD PhD	Medical University of South Carolina
Principal Investigator:	Kevin D Judy, MD	University of Pennsylvania
Principal Investigator:	William R Shapiro, MD	Barrow Neurological Institute
Principal Investigator:	Andrew E Sloan, MD, FACS	University Hospitals Case Medical Center

Information Provided By

Peregrine Pharmaceuticals

Verification Date

December 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP