Access Protocol for MAB-425 Radiolabeled With I-125 for High Grade Gliomas
This trial is active, not recruiting.
|Conditions||glioblastoma multiforme, astrocytoma anaplastic foci|
|Treatment||mab-425 radiolabeled with i-125|
|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).
|Intervention model||single group assignment|
Prevention of disease progression
time frame: 3 months after first course with follow-up
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
|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|
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