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

Primary Purpose

Glioblastoma Multiforme

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for Glioblastoma Multiforme focused on measuring glioblastoma multiforme, GBM, brain cancer, Cotara, radioactive isotope, monoclonal antibody, Glioblastoma multiforme at first relapse

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Barrow Neurological Institute
University of Pennsylvania, Department of Neurosurgery
Medical University of South Carolina
Amrita Institute of Medical Sciences and Research Center,
Manipal Institute for Neurological Disorders,
Department of Neurosurgery Jaslok Hospital and Research Centre
All India Instutite of Medical Sciences

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

Outcomes

Primary Outcome Measures

To confirm the safety and tolerability of the maximum tolerated dose

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00677716

First Posted

May 12, 2008

Last Updated

April 23, 2014

Sponsor

Peregrine Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00677716

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2014

Overall Recruitment Status

Completed

Study Start Date

July 2007 (undefined)

Primary Completion Date

September 2011 (Actual)

Study Completion Date

November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Peregrine Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glioblastoma Multiforme

Keywords

glioblastoma multiforme, GBM, brain cancer, Cotara, radioactive isotope, monoclonal antibody, Glioblastoma multiforme at first relapse

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

41 (Actual)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

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

Other Intervention Name(s)

Cotara®

Intervention Description

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

Primary Outcome Measure Information:

Title

To confirm the safety and tolerability of the maximum tolerated dose

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Deepak K Gupta, MBBS,MS,MCh

Organizational Affiliation

All India Institute of Medical Sciences, New Delhi

Official's Role

Principal Investigator

Facility Information:

Facility Name

Barrow Neurological Institute

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85013

Country

United States

Facility Name

University of Pennsylvania, Department of Neurosurgery

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

Medical University of South Carolina

City

Charleston,

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

Facility Name

Amrita Institute of Medical Sciences and Research Center,

City

Cochin

State/Province

Kerala

ZIP/Postal Code

682026

Country

India

Facility Name

Manipal Institute for Neurological Disorders,

City

Bangalore

ZIP/Postal Code

560 017

Country

India

Facility Name

Department of Neurosurgery Jaslok Hospital and Research Centre

City

Mumbai

Country

India

Facility Name

All India Instutite of Medical Sciences

City

New Delhi

ZIP/Postal Code

110029

Country

India

12. IPD Sharing Statement

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

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