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
    • Allocation: N/A
    • 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

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