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

NCT ID: NCT00677716

Last Updated: 2014-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2011-11-30

Brief 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.

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.

Conditions

Glioblastoma Multiforme

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

Given as a single interstitial infusion over approximately 25 hours at a dose of 2.5 mCi/cc.

Interventions

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

Given as a single interstitial infusion over approximately 25 hours at a dose of 2.5 mCi/cc.

Intervention Type: DRUG

Other Intervention Names

Cotara®

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peregrine Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Deepak K Gupta, MBBS,MS,MCh

Role: PRINCIPAL_INVESTIGATOR

All India Institute of Medical Sciences

Locations

Barrow Neurological Institute

Phoenix, Arizona, United States

University of Pennsylvania, Department of Neurosurgery

Philadelphia, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Amrita Institute of Medical Sciences and Research Center,

Kochi, Kerala, India

Manipal Institute for Neurological Disorders,

Bangalore, , India

Department of Neurosurgery Jaslok Hospital and Research Centre

Mumbai, , India

All India Instutite of Medical Sciences

New Delhi, , India

Countries

United States; India

Other Identifiers

PPHM 0503

Identifier Type: -

Identifier Source: org_study_id