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

Recurrent Glioblastoma Multiforme Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00509301
• Other study ID #: PPHM 0602
• Status: Completed
• Phase: Phase 1
• First received: July 27, 2007
• Last updated: August 3, 2011
• Start date: November 2006
• Est. completion date: March 2010

Study information

• Verified date: August 2011
• Source: Peregrine Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00516789

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Glioblastoma
• Recurrent Glioblastoma Multiforme

Intervention

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.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University Hospitals Case Medical Center	Cleveland	Ohio
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Barrow Neurological Institute	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Peregrine Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To confirm dose limit and maximum tolerated dose and to characterize radiation distribution		unknown	Yes