Access Protocol for MAB-425 Radiolabeled With I-125 for High Grade Gliomas

Sponsor

Drexel University (Other)

Overall Status

Unknown status

CT.gov ID

NCT01317888

Collaborator

(none)

Enrollment

Arm

Study Details

Study Description

Brief Summary

The purpose of this access protocol is to allow patients with brain tumors who had previously received 125I-MAB 425 to receive additional course(s) of 125I-MAB 425 until their brain tumor begins to grow, they develop side effects to the treatment, or their medical condition changes (e.g., you become pregnant, become infected with human immunodeficiency virus (HIV) or develop another cancer).

Condition or Disease	Intervention/Treatment	Phase
Glioblastoma Multiforme Astrocytoma Anaplastic Foci	Drug: MAB-425 radiolabeled with I-125	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

11 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An Access Protocol for Continued Use of Anti-Epidermal Growth Factor Receptor-425 (Anti-EGFr-425) Monoclonal Antibody Radiolabeled With 1-125 for High Grade Gliomas

Study Start Date :

Jan 1, 2010

Anticipated Primary Completion Date :

Jan 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treated with MAB-425 All patients receive the same treatment of MAb-425 +Iodine 125 in a total of three injections.	Drug: MAB-425 radiolabeled with I-125 MAb425 anti-epidermal growth receptor) and Iodine-125 will be given as an injection for a total of three treatments each separated by one week.

Arm

Intervention/Treatment

Experimental: Treated with MAB-425

All patients receive the same treatment of MAb-425 +Iodine 125 in a total of three injections.

Drug: MAB-425 radiolabeled with I-125

MAb425 anti-epidermal growth receptor) and Iodine-125 will be given as an injection for a total of three treatments each separated by one week.

Outcome Measures

Primary Outcome Measures

Prevention of disease progression [3 months after first course with follow-up]
For the treatment to not have failed, diagnostic scans (enhanced MRI's and/or CT scans) must show nothing greater than or equal to a 25% increase in the sum of the area of the tumor measurements from baseline

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

18 Years or Older
Previous treatment with at least one course of 125I-MAB 425 (one course = 3 infusions)
Karnofsky performance status > 70%
Hemoglobin > 10.0 g/dL, White Blood Cells > 4,000/mm3, Platelets > 100,000/mm3, BUN < 25 mg/dL, Creatinine < 1.5 mg/dL
Signed informed consent
Pathologic confirmation of GBM or AAF
A negative beta hCG test for women of childbearing potential
Negative HAMA test