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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

June 11, 2009
February 11, 2013
August 2009
December 2010   (final data collection date for primary outcome measure)
Evaluation for toxicity [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00964756 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
A Study of an Infectivity Enhanced Suicide Gene Expressing Adenovirus for Ovarian Cancer in Patients With Recurrent Ovarian and Other Selected Gynecologic Cancers
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)

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.

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Ovarian Cancer
  • 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
Experimental: Gene therapy
Interventions:
  • Genetic: Ad5.SSTR/TK.RGD
  • Drug: Ganciclovir (GCV)
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
11
April 2012
December 2010   (final data collection date for primary outcome measure)

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)
Female
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00964756
F080807013 (UAB 0821), 5R01CA090547-02, OGCA Link # 000137326, UAB 0821
Yes
Ronald D. Alvarez, University of Alabama at Birmingham
University of Alabama at Birmingham
National Cancer Institute (NCI)
Principal Investigator: Ronald D Alvarez, MD University of Alabama at Birmingham
University of Alabama at Birmingham
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP