Brain and Central Nervous System Tumors Clinical Trial
Official title:
A PHASE I TRIAL OF HSV-TK ADENOVIRUS GENE THERAPY FOR PRIMARY BRAIN TUMORS
RATIONALE: Inserting the gene for herpes virus into a person's cells may improve the body's
ability to fight cancer or make the cancer more sensitive to chemotherapy using antiviral
drugs such as ganciclovir.
PURPOSE: Phase I trial to study the effectivenesss of gene therapy in treating patients with
primary brain tumors.
OBJECTIVES: I. Assess the response to a stereotactically administered recombinant adenovirus
vector carrying the herpes simplex virus thymidine kinase gene (H5.010RSVTK) followed by
intravenous ganciclovir in patients with recurrent malignant glioma. II. Estimate the maximum
tolerated dose of H5.010RSVTK in these patients. III. Describe the toxic effects of
H5.010RSVTK. IV. Assess the efficiency of gene transfer and duration of transgene expression
in these patients. V. Assess quantitative and qualitative glucose metabolic activity of
tumoral sites by positron emission tomography. VI. Analyze the immunologic response to
adenovirus transduction in these patients. VII. Determine the benefit and toxicity of
multiple doses of H5.010RSVTK in patients with resectable tumors.
OUTLINE: This is a dose-finding study. All patients receive stereotactically injected
H5.010RSVTK (a recombinant adenovirus vector containing the herpes simplex virus thymidine
kinase gene). Cohorts of 3-6 patients receive escalating doses of H5.010RSVTK until the
maximum tolerated dose is reached. Ganciclovir is then given on the third post-injection day.
Patients with unresectable tumors receive ganciclovir for 14 consecutive days. Patients with
resectable tumors receive ganciclovir for 7 consecutive days before undergoing craniotomy
with optimal debulking and injection of a second dose of the adenovirus vector followed by
ganciclovir for 14 more days. Patients are followed monthly for survival.
PROJECTED ACCRUAL: A total of 18 patients (9 with resectable tumors and 9 with unresectable
tumors) will be entered over 3 years.
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