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

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00509301
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Peregrine Pharmaceuticals
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Sunil J Patel, MDKenneth M Spicer, MD PhDKevin D Judy, MDWilliam R Shapiro, MDAndrew E Sloan, MD, FACS
Principal Investigator Affiliation Medical University of South CarolinaMedical University of South CarolinaUniversity of PennsylvaniaBarrow Neurological InstituteUniversity Hospitals Cleveland Medical Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Recurrent Glioblastoma Multiforme
Additional Details

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.

Arms & Interventions

Arms

Experimental: 1

1.5 mCi/cc

Experimental: 2

2.0 mCi/cc

Experimental: 3

2.5 mCi/cc

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Barrow Neurological Institute, Phoenix, Arizona

Status

Address

Barrow Neurological Institute

Phoenix, Arizona, 85013

University Hospitals Case Medical Center, Cleveland, Ohio

Status

Address

University Hospitals Case Medical Center

Cleveland, Ohio, 44106

University of Pennsylvania, Philadelphia, Pennsylvania

Status

Address

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

Medical University of South Carolina, Charleston, South Carolina

Status

Address

Medical University of South Carolina

Charleston, South Carolina, 29425

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