Neoplasm Metastasis Clinical Trial
Official title:
Phase I Clinical Trial: 2DG + Stereotactic Radiosurgery (SRS) Protocol for Treatment of Intracranial Metastases
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.
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.
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Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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