Know Cancer

or
forgot password

Phase I Clinical Trial: 2DG + Stereotactic Radiosurgery (SRS) Protocol for Treatment of Intracranial Metastases


Phase 1
21 Years
N/A
Not Enrolling
Both
Intracranial Neoplasms, Neoplasm Metastasis

Thank you

Trial Information

Phase I Clinical Trial: 2DG + Stereotactic Radiosurgery (SRS) Protocol for Treatment of Intracranial Metastases


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.


Inclusion Criteria:



- Ability to understand and the willingness to sign a written informed consent
document.

- 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
investigated.

- 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.

Exclusion Criteria:

- 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
excluded.

- 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
study requirements.

- 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
immediately.

- Inclusion of prisoners and other vulnerable populations: Prisoners and other
vulnerable populations, such as children, will not be enrolled.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety

Outcome Time Frame:

During treatment and 30 days post-treatment

Safety Issue:

Yes

Principal Investigator

John M. Buatti, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Iowa Hospitals & Clinics

Authority:

United States: Institutional Review Board

Study ID:

200506744

NCT ID:

NCT00247403

Start Date:

October 2005

Completion Date:

June 2008

Related Keywords:

  • Intracranial Neoplasms
  • Neoplasm Metastasis
  • Intracranial cancer
  • Cancer
  • 2DG
  • 2-deoxyglucose
  • Intracranial metastatic cancer
  • Neoplasms
  • Neoplasm Metastasis
  • Brain Neoplasms

Name

Location

University of Iowa Hospitals and ClinicsIowa City, Iowa  52242