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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: | NCT00038441 |
This is a clinical research study of a new investigational treatment for cancer called "DTI-015" to be given by intratumoral injection. Intratumoral injection is when drug is injected directly into the tumor. This study will help doctors find out what is the best dose level for DTI-015 and if this treatment can shrink tumors without causing severe side effects. The effects of the drug on the patient's quality of life (how the patient feels and what the patient can do) and their mental functions (reasoning and thinking abilities) will also be studied.
Condition | Intervention | Phase |
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Glioma Brain Neoplasms |
Drug: DTI-015 |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Central necrosis and/or central cystic areas are allowed as long as there is an enhancing rim with a thickness >5 mm.
Study ID Numbers: | ID95-115 |
Study First Received: | May 30, 2002 |
Last Updated: | November 11, 2005 |
ClinicalTrials.gov Identifier: | NCT00038441 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Malignant Glioma |
Neuroectodermal Tumors Brain Neoplasms Neoplasms, Germ Cell and Embryonal Neuroepithelioma Central Nervous System Diseases Central Nervous System Neoplasms |
Glioma Brain Diseases Nervous System Neoplasms Recurrence Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Neoplasms, Nerve Tissue Nervous System Diseases Central Nervous System Diseases Central Nervous System Neoplasms Brain Diseases Brain Neoplasms Neuroectodermal Tumors |
Neoplasms Neoplasms by Site Neoplasms, Germ Cell and Embryonal Glioma Neoplasms, Neuroepithelial Nervous System Neoplasms Neoplasms, Glandular and Epithelial |