A Study of an Infectivity Enhanced Suicide Gene Expressing Adenovirus for Ovarian Cancer in Patients With Recurrent Ovarian and Other Selected Gynecologic Cancers

Phase 1

Completed

• Conditions: Ovarian Cancer
• Interventions: Genetic: Ad5.SSTR/TK.RGD; Drug: Ganciclovir (GCV)

• Registration Number: NCT00964756
• Lead Sponsor: University of Alabama at Birmingham

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-06-11
• Study Start: 2009-08
• Study First Submitted QC: 2009-08-24
• Study First Posted: 2009-08-25
• Primary Completion: 2010-12
• Study Completion: 2012-04
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-11
• Last Update Posted: 2013-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 11

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gene therapy	Ad5.SSTR/TK.RGD	-
Gene therapy	Ganciclovir (GCV)	-

Primary Outcome Measures

Name	Time	Method
Evaluation for toxicity	2 years

Secondary Outcome Measures

Name	Time	Method
Molecular Studies for evaluation of gene transfer and generation of wild type adenovirus, viral shedding and clinical efficacy	30 days

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States