Phase I Clinical Trial: 2DG + Stereotactic Radiosurgery (SRS) Protocol for Treatment of Intracranial Metastases
- Ability to understand and the willingness to sign a written informed consent
- Brain metastases from histologically confirmed extracranial cancer or previously
confirmed intracranial carcinoma. Carcinoma must be staged using the American Joint
Committee on Cancer (AJCC) staging criteria version 6.
- Morphologically well-defined tumor mass on computed tomography (CT)/magnetic
resonance imaging [MRI] (largest diameter less than 40 mm) after resection.
- Intracranial mass or masses ≤ 4 cm in greatest diameter. Patients with multiple
masses will be eligible if their radiosurgery treatment time is expected to last less
than one hour (typically a maximum of 6 lesions).
- Standard institutional radiotherapeutic treatment is stereotactic radiosurgery
delivered using bite-plate localization.
- Greater than or equal to 21 years of age. Pediatric subjects represent a minority of
patients who otherwise meet the eligibility criteria. Inclusion of children in a
different study would be considered if therapy is found to be effective in adults and
not as part of this trial because the safety of 2DG in children has not been
- Karnofsky greater than or equal to 70% at time of screening
- Life expectancy of greater than 3 months
- Subjects must have normal organ and marrow function as defined below:
- serum glucose < 200 mg/dl
- hemoglobin A1C (HbA1c) < 8.5 %
- Contraceptive use in men and women of childbearing potential prior to, and for the
duration of, this study. The teratogenic effects of ionizing radiation are well
documented, and 2DG has the potential for teratogenic or abortifacient effects.
- Nursing of infants must be suspended during the study. There is an unknown but
potential risk for adverse events in infants nursing from patients treated with 2DG,
therefore breastfeeding must be discontinued for the duration of the study.
- Ability to ingest 50 ml of fluid either by mouth or feeding tube.
- Inclusion of women and minorities: Both men and women of all races and ethnic groups
are eligible for this trial.
- Subjects with diabetes mellitus, elevated HbA1c or elevated blood glucose.
- Subjects requiring a headring ('halo') immobilization for standard stereotactic
localization. Patients with metastases adjacent to optic chiasm, optic nerve or
other radiosensitive tissue necessitating the accuracy of a headring will be
- Subjects must not be receiving any other investigational agents.
- Subjects with a history of myocardial infarction in the past year and/or dependent on
beta-adrenergic blocking agents.
- Subjects with an uncontrolled seizure disorder.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
- Because there is an unknown but potential risk for adverse events in nursing infants
secondary to treatment of the nursing mother with 2DG, breastfeeding must be
discontinued while the nursing mother is treated.
- Pregnant women are excluded from this study. The teratogenic effects of ionizing
radiation are well documented, and 2DG has the potential for teratogenic or
abortifacient effects. Women of childbearing potential must have a negative pregnancy
test result immediately prior to the study and should they become pregnant or suspect
that they are pregnant during the study, they must inform their treating physicians
- Inclusion of prisoners and other vulnerable populations: Prisoners and other
vulnerable populations, such as children, will not be enrolled.