Phase I Trial of Adenovirus-Mediated Wild-Type P53 Gene Therapy for Malignant Gliomas
OBJECTIVES: I. Determine the biological effects at the molecular level of intratumoral
administration of adenovirus p53 gene (Ad-p53) in patients with malignant primary glioma.
II. Determine the maximum tolerated dose of intratumoral Ad-p53 in these patients. III.
Evaluate the qualitative and quantitative toxicity of intratumoral Ad-p53 in this patient
OUTLINE: This is a dose-escalation, multicenter study. Patients receive an initial
intratumoral stereotactic injection of adenovirus p53 (Ad-p53) over 10 minutes on day 1. In
the absence of unacceptable toxicity resulting from this initial injection, patients then
undergo tumor resection and receive a series of 1-minute injections of Ad-p53 into the
resected tumor cavity wall on day 4. Cohorts of 3-6 patients receive escalating doses of
Ad-p53. If 2 of 3 or 3 of 6 patients experience dose limiting toxicity (DLT) at a particular
dose level, escalation ceases and the maximum tolerated dose is defined as the previous dose
level. Patients are followed closely for 12 weeks, then every 2 weeks for 8 weeks, then
every 4 weeks for 8 weeks, and then every 8 weeks until death.
PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study.
Primary Purpose: Treatment
Frederick F. Lang, MD
M.D. Anderson Cancer Center
United States: Federal Government
|University of Texas - MD Anderson Cancer Center||Houston, Texas 77030-4009|
|University of Michigan Comprehensive Cancer Center||Ann Arbor, Michigan 48109-0752|
|Simmons Cancer Center - Dallas||Dallas, Texas 75235-9154|
|University of Texas Health Science Center at San Antonio||San Antonio, Texas 78284-7811|
|UCSF Cancer Center and Cancer Research Institute||San Francisco, California 94115-0128|
|University of Pittsburgh Cancer Institute||Pittsburgh, Pennsylvania 15213|
|University of Wisconsin Comprehensive Cancer Center||Madison, Wisconsin 53792|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|