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 I

MedlinePlus related topics:

Cancer

U.S. FDA Resources

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

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:	September 2008
Estimated Primary Completion Date:	September 2008 (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 Spallone, MBA	714-508-6097	jspallone@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

More Information

Responsible Party:	Peregrine Pharmaceuticals ( Jennifer Spallone/Senior Clinical Research Associate )
Study ID Numbers:	PPHM 0602
First Received:	July 27, 2007
Last Updated:	July 16, 2008
ClinicalTrials.gov Identifier:	NCT00509301
Health Authority:	United States: Food and Drug Administration

Keywords provided by Peregrine Pharmaceuticals:

brain cancer

Cotara

radioactive isotope

monoclonal antibody

radiation distribution

Study placed in the following topic categories:

Antibodies, Monoclonal

Neuroectodermal Tumors

Brain Neoplasms

Glioblastoma

Antibodies

Glioblastoma multiforme

Astrocytoma

Neoplasms, Germ Cell and Embryonal

Neuroepithelioma

Glioma

Recurrence

Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Disease Attributes

Neoplasms

Pathologic Processes

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Neoplasms, Neuroepithelial

ClinicalTrials.gov processed this record on August 29, 2008

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