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

Sponsor:	Peregrine Pharmaceuticals
Information provided by:	Peregrine Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00509301

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 I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
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: 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
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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.
2: Experimental 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.
3: Experimental 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.

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

Contacts

Contact: Jennifer Lai, MBA, CCRA	714-508-6097	jlai@peregrineinc.com
Contact: Dianne Uphoff, RN, CCRA	714-508-6031	duphoff@peregrineinc.com

Locations

United States, Arizona
Barrow Neurological Institute	Recruiting
Phoenix, Arizona, United States, 85013
Contact: Andrea Ralph, RN OCN 602-406-6262
Principal Investigator: William R Shapiro, MD
United States, Ohio
University Hospitals Case Medical Center	Recruiting
Cleveland, Ohio, United States, 44106
Contact: Dawn M Diorio, R.N., B.S.N., B.A. 216-983-5167 Dawn.Diorio@UHHospitals.org
Principal Investigator: Andrew E Sloan, MD, FACS
United States, Pennsylvania
University of Pennsylvania	Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Joanna Lopinto, BSN, RN 215-615-4590 JLopinto@uphs.upenn.edu
Principal Investigator: Kevin Judy, MD
United States, South Carolina
Medical University of South Carolina	Recruiting
Charleston, South Carolina, United States, 29425
Contact: Bonnie Muntz-Pope 843-792-8967 muntzpob@musc.edu
Principal Investigator: Sunil J Patel, MD
Principal Investigator: Kenneth Spicer, MD

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 Hospitals Case Medical Center

More Information

No publications provided

Responsible Party:	Peregrine Pharmaceuticals ( Jennifer Lai, MBA, CCRA )
Study ID Numbers:	PPHM 0602
Study First Received:	July 27, 2007
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00509301 History of Changes
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
Disease Attributes
Neoplasms by Histologic Type
Astrocytoma
Neoplasms, Nerve Tissue
Recurrence
Neuroectodermal Tumors

Neoplasms
Pathologic Processes
Neoplasms, Germ Cell and Embryonal
Glioma
Neoplasms, Neuroepithelial
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 05, 2009