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Safety & Radiation Distribution Study of Cotara® in Patients With Recurrent Glioblastoma Multiforme

Primary Purpose

Recurrent Glioblastoma Multiforme

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

131-I-chTNT-1/B MAB

About this trial

This is an interventional treatment trial for Recurrent Glioblastoma Multiforme focused on measuring brain cancer, Cotara, radioactive isotope, monoclonal antibody, radiation distribution

Eligibility Criteria

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

Inclusion Criteria:

Patients with recurrent GBM
Patients with a Clinical Target Volume between 5 and 60 cc (inclusive)
Patients of 18 years of age or older
Karnofsky Performance Status ≥ 60 at screening
Patients not on steroids or maintained on a stable corticosteroid regimen (± 4 mg) for at least 2 weeks prior to study entry

Exclusion Criteria:

Patients with infratentorial tumor(s), exophytic intra-ventricular tumor(s) or subependymal tumor spread extending greater than 2 cm
Patients with diffuse disease
Patients with known or suspected allergy to study medication or iodine
Patients who received investigational agents within 30 days prior to baseline
Patients who received surgical resection within 4 weeks from baseline
Patients with known HIV or evidence of active hepatitis
Patients who cannot undergo MRI

Sites / Locations

Barrow Neurological Institute
University Hospitals Case Medical Center
University of Pennsylvania
Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Arm Description

1.5 mCi/cc

2.0 mCi/cc

2.5 mCi/cc

Outcomes

Primary Outcome Measures

To confirm dose limit and maximum tolerated dose and to characterize radiation distribution

Secondary Outcome Measures

Full Information

NCT ID

NCT00509301

First Posted

July 27, 2007

Last Updated

August 3, 2011

Sponsor

Peregrine Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00509301

Brief Title

Safety & Radiation Distribution Study of Cotara® in Patients With Recurrent Glioblastoma Multiforme

Official Title

Open-label Dose Confirmation and Dosimetry Study of Interstitial 131I-chTNT-1/B MAb (Cotara®) for the Treatment of Recurrent Glioblastoma Multiforme

Study Type

Interventional

2. Study Status

Record Verification Date

August 2011

Overall Recruitment Status

Completed

Study Start Date

November 2006 (undefined)

Primary Completion Date

March 2010 (Actual)

Study Completion Date

March 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Peregrine Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

RATIONALE: 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. PURPOSE: This trial is studying the safety and radiation distribution of Cotara® in patients with recurrent glioblastoma multiforme.

Detailed Description

OBJECTIVES: Primary To confirm the dose limiting toxicities (DLT) and maximum tolerated dose (MTD) of 131I-chTNT-1/B MAb (Cotara®) when given as a single 25 hour interstitial infusion in patients with recurrent GBM To characterize the biodistribution and radiation dosimetry of Cotara® OUTLINE: This is an open-label, dose escalation study of Cotara®. All patients will receive 3 mCi of Cotara® for biodistribution and radiation dosimetry purposes. In addition, patients will receive escalating therapeutic dose levels of Cotara® for confirmation of the maximum tolerated dose (MTD). After completion of study treatment, patients are followed for a minimum of 12 weeks and until disease progression.

6. Conditions and Keywords

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

Recurrent Glioblastoma Multiforme

Keywords

brain cancer, Cotara, radioactive isotope, monoclonal antibody, radiation distribution

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

1.5 mCi/cc

Arm Title

Arm Type

Experimental

Arm Description

2.0 mCi/cc

Arm Title

Arm Type

Experimental

Arm Description

2.5 mCi/cc

Intervention Type

Drug

Intervention Name(s)

131-I-chTNT-1/B MAB

Other Intervention Name(s)

Cotara

Intervention Description

The study drug is given interstitially for approximately 25 hours at a dose of 1.5, 2.0, or 2.5 mCi/cc.

Primary Outcome Measure Information:

Title

To confirm dose limit and maximum tolerated dose and to characterize radiation distribution

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with recurrent GBM Patients with a Clinical Target Volume between 5 and 60 cc (inclusive) Patients of 18 years of age or older Karnofsky Performance Status ≥ 60 at screening Patients not on steroids or maintained on a stable corticosteroid regimen (± 4 mg) for at least 2 weeks prior to study entry Exclusion Criteria: Patients with infratentorial tumor(s), exophytic intra-ventricular tumor(s) or subependymal tumor spread extending greater than 2 cm Patients with diffuse disease Patients with known or suspected allergy to study medication or iodine Patients who received investigational agents within 30 days prior to baseline Patients who received surgical resection within 4 weeks from baseline Patients with known HIV or evidence of active hepatitis Patients who cannot undergo MRI

Overall Study Officials: