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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00677716
Other study ID # PPHM 0503
Secondary ID
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


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
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