Ovarian Cancer
Conditions
Keywords
ovarian cancer, Recurrent ovarian cancer and other gynecologic cancers
Brief summary
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.
Interventions
GENETICAd5.SSTR/TK.RGD
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
Sponsors
National Cancer Institute (NCI)
University of Alabama at Birmingham
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients must have histologically documented invasive epithelial ovarian, extraovarian, fallopian tube or endometrial carcinoma. * Patients must have persistent or recurrent disease after standard debulking/staging surgery and conventional therapy. * Patients must have evidence of intraabdominal disease; disease may be measurable or nonmeasurable. * Patients must have a GOG performance status of 0, 1, or 2, and have a life expectancy of greater than 3 months. * Patients must have adequate hematologic, renal, and hepatic function defined as: * WBC \> 3,000 ul * Granulocytes \> 1,500 ul * Platelets \> 100,000 * Creatinine clearance \> 80 mg/dl or serum creatinine \> 2.0 * Serum transaminases \< 2.5 x upper limits of normal * Normal serum bilirubin * PT/PTT/INR \< 1.5 x institutional ULN * O2 saturation \> or = 92 % * Patients must be 19 years or older and must have signed informed consent
Exclusion criteria
* Patients with epithelial tumors of low malignant potential, stromal tumors and germ cell tumors of the ovary are ineligible to participate in the study. * Patients with the only site of disease located beyond the abdominal cavity are ineligible to participate in the study. * Patients who are pregnant or lactating are ineligible to participate in the study. * Patients with a GOG performance status of 3 or 4 are ineligible to participate in the study. * Patients with active heart disease (characterized by angina, unstable arrhythmia, congestive heart failure or EF \< 55%, pulmonary hyper- tension, active or chronic debilitating pulmonary disease(i.e., active pneumonia, severe COPD, pulmonary edema, O2 saturation \< 92%), or coagulation disorders (i.e. bleeding disorders, or on therapeutic anti- coagulants)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation for toxicity | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Molecular Studies for evaluation of gene transfer and generation of wild type adenovirus, viral shedding and clinical efficacy | 30 days |
Countries
United States
Outcome results
None listed