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

Phase 2

Completed

• Conditions: Glioblastoma Multiforme
• Interventions: Drug: 131I-chTNT-1/B MAb (Cotara)

• Registration Number: NCT00677716
• Lead Sponsor: Peregrine Pharmaceuticals

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.

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2008-05-12
• Study First Submitted QC: 2008-05-13
• Study First Posted: 2008-05-14
• Primary Completion: 2011-09
• Study Completion: 2011-11
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-23
• Last Update Posted: 2014-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
131I-chTNT-1/B MAb (Cotara)	131I-chTNT-1/B MAb (Cotara)	-

Primary Outcome Measures

Name	Time	Method
To confirm the safety and tolerability of the maximum tolerated dose

Secondary Outcome Measures

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

Trial Locations

Locations (7)

Department of Neurosurgery Jaslok Hospital and Research Centre; 🇮🇳 Mumbai, India

Medical University of South Carolina; 🇺🇸 Charleston,, South Carolina, United States

Amrita Institute of Medical Sciences and Research Center,; 🇮🇳 Cochin, Kerala, India

Barrow Neurological Institute; 🇺🇸 Phoenix, Arizona, United States

Manipal Institute for Neurological Disorders,; 🇮🇳 Bangalore, India

All India Instutite of Medical Sciences; 🇮🇳 New Delhi, India

University of Pennsylvania, Department of Neurosurgery; 🇺🇸 Philadelphia, Pennsylvania, United States