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Dose Confirmation Study of Cotara for the Treatment of Glioblastoma Multiforme at First Relapse

Study Purpose

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.

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 - 75 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Histologically confirmed GBM.
  • - Clinical Target Volume between 5 and 60 cc (inclusive) - 18 to 75 years old (inclusive) - Karnofsky Performance Status ≥ 70 percent.
  • - If on steroids dose (± 4mg/day) must be stable for at least two weeks prior to screening/baseline visit.
If not on steroids for two weeks prior to screening/baseline visit are allowed.
  • - Adequate hematology.
  • - Adequate renal function.
  • - Adequate liver function.

Exclusion Criteria:

  • - Infratentorial tumor(s), tumor(s) that communicate with the ventricles or intraventricular disease.
  • - Bilateral non-contiguous gadolinium enhancing tumor.
  • - Diffuse disease (i.e., any satellite lesions less than 1.5 cm from anticipated location of any catheter tip or less than two satellite lesions) - Known or suspected allergy to study medication or iodine.
  • - Surgical procedure within four weeks of baseline.
  • - More than one prior chemotherapy regime or chemotherapy within four weeks (nitrosourea-based within six weeks) of baseline.
  • - Radiation therapy within four weeks of baseline.
  • - Investigational agent within last 30 days.
  • - Previous treatment with any chimeric monoclonal antibody.
  • - HIV positive.
- Evidence of active hepatitis

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.

 NCT00677716
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 2
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.

 Deepak K Gupta, MBBS,MS,MCh
Principal Investigator Affiliation All India Institute of Medical Sciences, New Delhi
Agency Class

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

 Industry
Overall Status Completed
Countries India, United States
Conditions

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

 Glioblastoma Multiforme
Additional Details

To confirm the safety and tolerability of the Maximum Tolerated Dose (MTD) of 131I-chTNT-1/B MAb given as a single interstitial infusion in patients with glioblastoma multiforme at first relapse. To estimate overall survival, progression free survival and proportion of patients alive at six months after treatment.

Arms & Interventions

Arms

Experimental: 131I-chTNT-1/B MAb (Cotara)

Interventions

Drug: - 131I-chTNT-1/B MAb (Cotara)

Given as a single interstitial infusion over approximately 25 hours at a dose of 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

Philadelphia, Pennsylvania

Status

Address

University of Pennsylvania, Department of Neurosurgery

Philadelphia, Pennsylvania, 19104

Medical University of South Carolina, Charleston,, South Carolina

Status

Address

Medical University of South Carolina

Charleston,, South Carolina, 29425

International Sites

Cochin, Kerala, India

Status

Address

Amrita Institute of Medical Sciences and Research Center,

Cochin, Kerala, 682026

Bangalore, India

Status

Address

Manipal Institute for Neurological Disorders,

Bangalore, , 560 017

Mumbai, India

Status

Address

Department of Neurosurgery Jaslok Hospital and Research Centre

Mumbai, ,

All India Instutite of Medical Sciences, New Delhi, India

Status

Address

All India Instutite of Medical Sciences

New Delhi, , 110029

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