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

Purpose

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.

Condition	Intervention	Phase
Recurrent Glioblastoma Multiforme	Drug: 131-I-chTNT-1/B MAB	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Open-label Dose Confirmation and Dosimetry Study of Interstitial 131I-chTNT-1/B MAb (Cotara®) for the Treatment of Recurrent Glioblastoma Multiforme

Resource links provided by NLM:

MedlinePlus related topics: Brain Cancer Cancer

U.S. FDA Resources

Further study details as provided by Peregrine Pharmaceuticals:

Primary Outcome Measures:

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

Estimated Enrollment:	12
Study Start Date:	November 2006
Study Completion Date:	March 2010
Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 1.5 mCi/cc	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
Experimental: 2 2.0 mCi/cc	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
Experimental: 3 2.5 mCi/cc	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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00509301

Locations

United States, Arizona
Barrow Neurological Institute
Phoenix, Arizona, United States, 85013
United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425

Sponsors and Collaborators

Peregrine Pharmaceuticals

Investigators

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 Hospital Case Medical Center

More Information

No publications provided

Responsible Party:	Jennifer Lai, MBA, CCRA, Peregrine Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00509301 History of Changes
Obsolete Identifiers:	NCT00516789
Other Study ID Numbers:	PPHM 0602
Study First Received:	July 27, 2007
Last Updated:	August 3, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Peregrine Pharmaceuticals:

brain cancer
Cotara
radioactive isotope
monoclonal antibody
radiation distribution

Additional relevant MeSH terms:

Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors

Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on May 19, 2013