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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Information provided by (Responsible Party): | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00805376 |
Purpose
The goal of this clinical research study is to find the highest tolerable dose of DELTA-24-RGD-4C that can be injected directly into brain tumors and into the surrounding brain tissue where tumor cells can multiply. A second goal is to study how the new drug DELTA-24-RGD-4C affects brain tumor cells and the body in general.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain Cancer Central Nervous System Diseases |
Drug: DELTA-24-RGD-4C Procedure: Tumor Removal |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
|---|---|
|
Experimental: Group A: DELTA-24-RGD-4C
Surgical procedure precisely injects DELTA-24-RGD-4C through a catheter (small tube) into brain tumor.
|
Drug: DELTA-24-RGD-4C
Surgical procedure precisely injects DELTA-24-RGD-4C through a catheter (small tube) into brain tumor.
|
|
Experimental: Group B: DELTA-24-RGD-4C + Surgery
DELTA-24-RGD-4C injection + Tumor removal
|
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
Other Name: Craniotomy
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Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
More Information
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00805376 History of Changes |
| Other Study ID Numbers: | ID01-310 |
| Study First Received: | December 8, 2008 |
| Last Updated: | March 2, 2012 |
| 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 |
|
Brain Neoplasms Central Nervous System Diseases Glioma Nervous System Diseases Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Neoplasms |
Brain Diseases Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |