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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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Ronald D. Alvarez, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00964756
First received: June 11, 2009
Last updated: February 11, 2013
Last verified: February 2013
  Purpose

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

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Evaluation for toxicity [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Molecular Studies for evaluation of gene transfer and generation of wild type adenovirus, viral shedding and clinical efficacy [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Enrollment: 11
Study Start Date: August 2009
Study Completion Date: April 2012
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00964756

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: Ronald D Alvarez, MD University of Alabama at Birmingham
  More Information

Publications:
Responsible Party: Ronald D. Alvarez, Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00964756     History of Changes
Other Study ID Numbers: F080807013 (UAB 0821), 5R01CA090547-02, OGCA Link # 000137326, UAB 0821
Study First Received: June 11, 2009
Last Updated: February 11, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Alabama at Birmingham:
ovarian cancer
Recurrent ovarian cancer and other gynecologic cancers

Additional relevant MeSH terms:
Ovarian Neoplasms
Adnexal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on November 20, 2014