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Sponsored by: |
M.D. Anderson Cancer Center |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00805376 |
Objectives:
Condition | Intervention | Phase |
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Brain Cancer Central Nervous System Diseases |
Drug: DELTA-24-RGD-4C Procedure: Tumor Removal |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase I Trial of Conditionally Replication-Competent Adenovirus (Delta-24-RGD) for Recurrent Malignant Gliomas |
Estimated Enrollment: | 96 |
Study Start Date: | December 2008 |
Estimated Primary Completion Date: | December 2021 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Group A: Experimental
DELTA-24-RGD-4C
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Drug: DELTA-24-RGD-4C
Surgical procedure precisely injects DELTA-24-RGD-4C through a catheter (small tube) into brain tumor.
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Group B: Experimental
DELTA-24-RGD-4C + Surgery
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Drug: DELTA-24-RGD-4C
Surgical procedure precisely injects DELTA-24-RGD-4C through a catheter (small tube) into brain tumor.
Procedure: Tumor Removal
Surgical Tumor Resection
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Frederick F. Lang, MD, BS | 713-563-2883 |
United States, Texas | |
UT MD Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Principal Investigator: Frederick F. Lang, MD, BS |
Principal Investigator: | Frederick F. Lang, MD, BS | UT MD Anderson Cancer Center |
Responsible Party: | UT MD Anderson Cancer Center ( Frederick F. Lang, MD/Assistant Professor ) |
Study ID Numbers: | ID01-310 |
Study First Received: | December 8, 2008 |
Last Updated: | January 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00805376 |
Health Authority: | United States: Food and Drug Administration |
Brain Brain Cancer Central Nervous System Diseases CNS |
Conditionally Replication-Competent Adenovirus Delta-24-RGD Recurrent Malignant Gliomas malignant brain tumor |
Neuroectodermal Tumors Brain Neoplasms Neoplasms, Germ Cell and Embryonal Adenoviridae Infections Neuroepithelioma Central Nervous System Diseases |
Central Nervous System Neoplasms Glioma Brain Diseases Nervous System Neoplasms Recurrence Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Histologic Type Neoplasms by Site |
Neoplasms, Nerve Tissue Nervous System Diseases Neoplasms, Neuroepithelial |