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Sponsored by: |
University of Iowa |
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Information provided by: | University of Iowa |
ClinicalTrials.gov Identifier: | NCT00247403 |
Ionizing radiation produces cancer cell death by creating high levels of reactive oxygen species (ROS), such as superoxide and hydrogen peroxide, in irradiated cells. Cancer cells are preferentially affected by ROS. The investigators, therefore, propose that interfering with the detoxification of ROS will make radiation more toxic to cancer cells. Several cellular mechanisms exist to detoxify ROS, and glucose metabolism plays an important role in many of these mechanisms. The investigators propose that interfering with glucose metabolism will sensitize cancer cells to radiation.
The investigators' central hypothesis is that 2DG will sensitize cancer cells to ionizing radiation by inhibiting the use of glucose to detoxify reactive oxygen species produced by radiation. As an initial step to evaluate this hypothesis, the investigators have designed this phase I study.
Condition | Intervention | Phase |
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Intracranial Neoplasms Neoplasm Metastasis |
Drug: 2-deoxyglucose (2DG) |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | Phase I Clinical Trial: 2DG + Stereotactic Radiosurgery (SRS) Protocol for Treatment of Intracranial Metastases |
Estimated Enrollment: | 30 |
Study Start Date: | October 2005 |
Estimated Study Completion Date: | June 2011 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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2DG: Experimental |
Drug: 2-deoxyglucose (2DG)
Addition of 2DG to stereotactic radiosurgery. Dose escalation study.
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Radiosurgery is a proven treatment option for intracranial metastases. This trial is an initial effort to potentiate the therapeutic effect of single dose stereotactic radiosurgery by combining a radiation sensitizing agent, 2DG, with radiosurgery in the treatment of intracranial metastases. Our preclinical studies indicate the degree of cancer cell radiosensitization using 2DG increases with increasing radiation dose. We therefore are interested to use 2DG with radiosurgery, since this technique allows for delivery of a large single dose of radiation.
This trial seeks to determine the maximum tolerable one time dose of 2DG that can be delivered to subjects receiving stereotactic radiosurgery. We will also measure the physiologic effects of 2DG on glucose and reactive oxygen species metabolism.
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects must have normal organ and marrow function as defined below:
Exclusion Criteria:
United States, Iowa | |
University of Iowa Hospitals and Clinics | |
Iowa City, Iowa, United States, 52242 |
Principal Investigator: | John M. Buatti, M.D. | University of Iowa Hospitals & Clinics |
Responsible Party: | Department of Radiation Oncology ( John M. Buatti, M.D. ) |
Study ID Numbers: | 200506744 |
Study First Received: | October 28, 2005 |
Last Updated: | June 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00247403 |
Health Authority: | United States: Institutional Review Board; United States: Food and Drug Administration |
Intracranial cancer Cancer 2DG 2-deoxyglucose Intracranial metastatic cancer |
Brain Neoplasms Neoplasm Metastasis Deoxyglucose Central Nervous System Diseases |
Central Nervous System Neoplasms Brain Diseases Nervous System Neoplasms |
Antimetabolites Anti-Infective Agents Neoplastic Processes Neoplasms Neoplasms by Site Pathologic Processes |
Molecular Mechanisms of Pharmacological Action Therapeutic Uses Nervous System Diseases Antiviral Agents Pharmacologic Actions |