A Phase II Study of Adjuvant Use of Anti-Epidermal Growth Factor Receptor EGFR-425 in High Grade Gliomas
| Status: | Completed |
|---|---|
| Conditions: | Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/14/2017 |
| Start Date: | January 1985 |
| End Date: | December 2012 |
A Phase II Study o the Adjuvant Use of Anti-Epidermal Growth Factor Receptor-425 (Anti-EGFR-425) Monoclonal Antibody Radiolabeled With I-125 for High Grade Gliomas
Data from the wistar institute indicated that this anti-body labeled with iodine-125 would
localized in the tumor cells of high grade gliomas of the brain. the project combines
surgery, radiation therapy, chemotherapy with the labeled antibody in a prospective phase II
trial in this disease entity.
localized in the tumor cells of high grade gliomas of the brain. the project combines
surgery, radiation therapy, chemotherapy with the labeled antibody in a prospective phase II
trial in this disease entity.
This is an open-label Phase II study of postoperative radiation therapy followed by
Iodine-125 radiolabeled anti-epidermal-growth-factor-receptor monoclonal antibody (125I-MAB
425) derived from cell cultures for high grade malignant gliomas. Each subject will receive
postoperative radiation therapy followed by 6.4 mg of 50 mCi labeled 125I-MAB 425 by
injection. This dosing regimen will be given three times generally within a two-week period
(days one, eight and 15 of therapy) for a total dose of 19.2 mg of 150 mCi labeled 125I-MAB
425 for each course of therapy. The main objective of this study is to determine if the
addition of 125I-MAB 425 to postoperative radiotherapy, with or without change, prolongs
absolute survival compared to historical control (postoperative radiation therapy alone) in
subjects with histologically proven high grade gliomas. The primary efficacy variable is
absolute survival and the secondary target variable will be time to progression of the tumor.
Multiple courses will be considered based on the subject`s clinical status.
Iodine-125 radiolabeled anti-epidermal-growth-factor-receptor monoclonal antibody (125I-MAB
425) derived from cell cultures for high grade malignant gliomas. Each subject will receive
postoperative radiation therapy followed by 6.4 mg of 50 mCi labeled 125I-MAB 425 by
injection. This dosing regimen will be given three times generally within a two-week period
(days one, eight and 15 of therapy) for a total dose of 19.2 mg of 150 mCi labeled 125I-MAB
425 for each course of therapy. The main objective of this study is to determine if the
addition of 125I-MAB 425 to postoperative radiotherapy, with or without change, prolongs
absolute survival compared to historical control (postoperative radiation therapy alone) in
subjects with histologically proven high grade gliomas. The primary efficacy variable is
absolute survival and the secondary target variable will be time to progression of the tumor.
Multiple courses will be considered based on the subject`s clinical status.
Inclusion Criteria:
- all cases above 18 years of age
Exclusion Criteria:
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