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

Drexel University11 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Glioblastoma Multiforme Astrocytoma Anaplastic Foci

Interventions

MAB-425 radiolabeled with I-125DRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 Exclusion Criteria: * Metastases or Second Primary Cancer * Iodine allergy * Inability to tolerate oral intake of Lugol's solution * HIV Infection * Positive HAMA test * Pregnancy * Uncontrolled Seizures

Outcomes

Primary Outcomes

Prevention of disease progression

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

Time frame: 3 months after first course with follow-up

Data from ClinicalTrials.gov

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