In spite of surgical and chemotherapeutic advances, long term survival for advanced and recurrent gynecologic cancers remains dismal and no curative treatment for recurrent disease exists. Novel treatment strategies are needed. This is a study to determine the maximally tolerated dose of and toxicities associated with intraperitoneal delivery of an infectivity enhanced adenovirus that expresses a suicide gene and an gene that allows imaging of gene transfer. This vector will be given in combination with intravenous ganciclovir in patients with recurrent ovarian and other gynecological cancers.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
11
Group 1 Day 1-3 IP 1 x 10 9th vp/d Group 2 Day 1-3 IP 5 x 10 10th vp/d Group 3 Day 1-3 IP 1 x 10 12th vp/d
GVC Day 5-18 IV 5 mg/kg BID all groups
University of Alabama at Birmingham
Birmingham, Alabama, United States
Evaluation for toxicity
Time frame: 2 years
Molecular Studies for evaluation of gene transfer and generation of wild type adenovirus, viral shedding and clinical efficacy
Time frame: 30 days
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