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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00964756
Recruitment Status : Completed
First Posted : August 25, 2009
Last Update Posted : February 13, 2013
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Ronald D. Alvarez, 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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Genetic: Ad5.SSTR/TK.RGD Drug: Ganciclovir (GCV) Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : August 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : April 2012

Arm Intervention/treatment
Experimental: Gene therapy Genetic: 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

Drug: Ganciclovir (GCV)
GVC Day 5-18 IV 5 mg/kg BID all groups

Primary Outcome Measures :
  1. Evaluation for toxicity [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Molecular Studies for evaluation of gene transfer and generation of wild type adenovirus, viral shedding and clinical efficacy [ Time Frame: 30 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00964756

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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
National Cancer Institute (NCI)
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Principal Investigator: Ronald D Alvarez, MD University of Alabama at Birmingham
Publications of Results:
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Responsible Party: Ronald D. Alvarez, Professor, University of Alabama at Birmingham Identifier: NCT00964756    
Other Study ID Numbers: F080807013 (UAB 0821)
5R01CA090547-02 ( U.S. NIH Grant/Contract )
OGCA Link # 000137326 ( Other Identifier: UAB )
UAB 0821 ( Other Identifier: UAB Department )
First Posted: August 25, 2009    Key Record Dates
Last Update Posted: February 13, 2013
Last Verified: February 2013
Keywords provided by Ronald D. Alvarez, University of Alabama at Birmingham:
ovarian cancer
Recurrent ovarian cancer and other gynecologic cancers
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Ganciclovir triphosphate
Antiviral Agents
Anti-Infective Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action