Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Prevention of disease progression
Outcome Description:
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
Outcome Time Frame:
3 months after first course with follow-up
Safety Issue:
No
Authority:
United States: Food and Drug Administration
Study ID:
18508
NCT ID:
NCT01317888
Start Date:
January 2010
Completion Date:
Related Keywords:
- Glioblastoma Multiforme
- Astrocytoma Anaplastic Foci
- high grade gliomas of the brain
- anti-body treatment
- survival
- Astrocytoma
- Glioblastoma
- Glioma