This trial is active, not recruiting.

Conditions glioblastoma multiforme, astrocytoma anaplastic foci
Treatment mab-425 radiolabeled with i-125
Sponsor Drexel University
Start date January 2010
End date January 2014
Trial size 11 participants
Trial identifier NCT01317888, 1043323, 18508


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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model single group assignment
Masking open label
Primary purpose treatment
All patients receive the same treatment of MAb-425 +Iodine 125 in a total of three injections.
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.

Primary Outcomes

Prevention of disease progression
time frame: 3 months after first course with follow-up

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in March 2011.
Information provided to ClinicalTrials.gov by Drexel University.