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Safety & Radiation Distribution Study of Cotara® in Patients With Recurrent Glioblastoma Multiforme
This study is currently recruiting participants.
Study NCT00509301   Information provided by Peregrine Pharmaceuticals
First Received: July 27, 2007   Last Updated: January 8, 2009   History of Changes

July 27, 2007
January 8, 2009
November 2006
June 2009   (final data collection date for primary outcome measure)
To confirm dose limit and maximum tolerated dose and to characterize radiation distribution [ Time Frame: unknown ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00509301 on ClinicalTrials.gov Archive Site
 
 
 
Safety & Radiation Distribution Study of Cotara® in Patients With Recurrent Glioblastoma Multiforme
Open-Label Dose Confirmation and Dosimetry Study of Interstitial 131I-chTNT-1/B MAb (Cotara®) for the Treatment of Recurrent Glioblastoma Multiforme

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.

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.

Phase I
Interventional
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Recurrent Glioblastoma Multiforme
Drug: 131-I-chTNT-1/B MAB
  • Experimental: 1.5 mCi/cc
  • Experimental: 2.0 mCi/cc
  • Experimental: 2.5 mCi/cc
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
12
June 2009
June 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Jennifer Lai, MBA, CCRA 714-508-6097 jlai@peregrineinc.com
Contact: Dianne Uphoff, RN, CCRA 714-508-6031 duphoff@peregrineinc.com
United States
 
NCT00509301
Jennifer Lai, MBA, CCRA, Peregrine Pharmaceuticals
PPHM 0602
Peregrine Pharmaceuticals
 
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
Peregrine Pharmaceuticals
January 2009

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