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

NCT00964756 | Completed Phase 1 DMC

• 4 other identifiers: F080807013 (UAB 0821)5R01CA090547-02OGCA Link # 000137326UAB 0821
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Cancer

Keywords

ovarian cancer; Recurrent ovarian cancer and other gynecologic cancers

Outcome Measures

Primary Outcomes (1)

• Evaluation for toxicity

  2 years

Secondary Outcomes (1)

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

  30 days

Study Arms (1)

Gene therapy

EXPERIMENTAL

Genetic: Ad5.SSTR/TK.RGD; Drug: Ganciclovir (GCV)

Interventions

Ad5.SSTR/TK.RGD 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

Gene therapy

Ganciclovir (GCV) DRUG

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

Gene therapy

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Related Publications (1)

• 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.

  PMID: 22510347 RESULT

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Ganciclovir

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Ronald D Alvarez, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 11, 2009
• First Posted: August 25, 2009
• Study Start: August 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: April 1, 2012
• Last Updated: February 13, 2013

Record last verified: 2013-02

Locations

US (1)