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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2012-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Ovarian Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Gene therapy

Group Type EXPERIMENTAL

Ad5.SSTR/TK.RGD

Intervention Type GENETIC

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

Ganciclovir (GCV)

Intervention Type DRUG

GVC Day 5-18 IV 5 mg/kg BID all groups

Interventions

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Ad5.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

Intervention Type GENETIC

Ganciclovir (GCV)

GVC Day 5-18 IV 5 mg/kg BID all groups

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

19 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No