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

Overview

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.

Full Title of Study: “Open-label, Dose Confirmation Study of Interstitial 131I-chTNT-1/B MAb (Cotara®) for the Treatment of Glioblastoma Multiforme (GBM) at First Relapse”

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2011

Detailed Description

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.

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.

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • To confirm the safety and tolerability of the maximum tolerated dose

Secondary Measures

  • To estimate overall survival, progression free survival and proportion of patients alive at six months after treatment.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Peregrine Pharmaceuticals
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Deepak K Gupta, MBBS,MS,MCh, Principal Investigator, All India Institute of Medical Sciences, New Delhi

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.