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

Primary Purpose

Ovarian Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ad5.SSTR/TK.RGD
Ganciclovir (GCV)
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring ovarian cancer, Recurrent ovarian cancer and other gynecologic cancers

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Gene therapy

Arm Description

Outcomes

Primary Outcome Measures

Evaluation for toxicity

Secondary Outcome Measures

Molecular Studies for evaluation of gene transfer and generation of wild type adenovirus, viral shedding and clinical efficacy

Full Information

First Posted
June 11, 2009
Last Updated
February 11, 2013
Sponsor
University of Alabama at Birmingham
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00964756
Brief Title
A Study of an Infectivity Enhanced Suicide Gene Expressing Adenovirus for Ovarian Cancer in Patients With Recurrent Ovarian and Other Selected Gynecologic Cancers
Official Title
A Phase I Study of AD5.SSTR/TK.RGD; A Tropism Modified Adenovirus Vector for Intraperitoneal Delivery of Therapeutic Genes and Additional Capability of Noninvasive Imaging of Gene Transfer in Patients With Recurrent Ovarian and Other Selected Gynecologic Cancers (Infectivity Enhanced Adenoviral Vectors for Ovarian CA)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
ovarian cancer, Recurrent ovarian cancer and other gynecologic cancers

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gene therapy
Arm Type
Experimental
Intervention Type
Genetic
Intervention Name(s)
Ad5.SSTR/TK.RGD
Intervention Description
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
Drug
Intervention Name(s)
Ganciclovir (GCV)
Intervention Description
GVC Day 5-18 IV 5 mg/kg BID all groups
Primary Outcome Measure Information:
Title
Evaluation for toxicity
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Molecular Studies for evaluation of gene transfer and generation of wild type adenovirus, viral shedding and clinical efficacy
Time Frame
30 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald D Alvarez, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22510347
Citation
Kim KH, Dmitriev I, O'Malley JP, Wang M, Saddekni S, You Z, Preuss MA, Harris RD, Aurigemma R, Siegal GP, Zinn KR, Curiel DT, Alvarez RD. A phase I clinical trial of Ad5.SSTR/TK.RGD, a novel infectivity-enhanced bicistronic adenovirus, in patients with recurrent gynecologic cancer. Clin Cancer Res. 2012 Jun 15;18(12):3440-51. doi: 10.1158/1078-0432.CCR-11-2852. Epub 2012 Apr 17.
Results Reference
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A Study of an Infectivity Enhanced Suicide Gene Expressing Adenovirus for Ovarian Cancer in Patients With Recurrent Ovarian and Other Selected Gynecologic Cancers

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