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

Glioblastoma Multiforme Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00677716
• Other study ID #: PPHM 0503
• Status: Completed
• Phase: Phase 2
• First received: May 12, 2008
• Last updated: April 23, 2014
• Start date: July 2007
• Est. completion date: November 2011

Study information

• Verified date: April 2014
• Source: Peregrine Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of India
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: November 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glioblastoma
• Glioblastoma Multiforme

Intervention

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.

Locations

Country	Name	City	State
India	Manipal Institute for Neurological Disorders,	Bangalore
India	Amrita Institute of Medical Sciences and Research Center,	Cochin	Kerala
India	Department of Neurosurgery Jaslok Hospital and Research Centre	Mumbai
India	All India Instutite of Medical Sciences	New Delhi
United States	Medical University of South Carolina	Charleston,	South Carolina
United States	University of Pennsylvania, Department of Neurosurgery	Philadelphia	Pennsylvania
United States	Barrow Neurological Institute	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Peregrine Pharmaceuticals

Countries where clinical trial is conducted

United States,  India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To confirm the safety and tolerability of the maximum tolerated dose		Unknown	Yes
Secondary	To estimate overall survival, progression free survival and proportion of patients alive at six months after treatment.		Unknown	No