NCT00005025

Brief Summary

RATIONALE: Gene therapy may make the body build an immune response to kill tumor cells. PURPOSE: Phase II trial to study the effectiveness of gene therapy in treating women who have refractory or relapsed ovarian epithelial cancer, fallopian tube cancer, or peritoneal cancer.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 6, 2000

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2000

Completed
2.9 years until next milestone

First Posted

Study publicly available on registry

May 5, 2003

Completed
Last Updated

November 6, 2013

Status Verified

March 1, 2003

First QC Date

April 6, 2000

Last Update Submit

November 5, 2013

Conditions

Fallopian Tube CancerOvarian CancerPrimary Peritoneal Cavity Cancer

Keywords

recurrent ovarian epithelial cancerfallopian tube cancerprimary peritoneal cavity cancer

Interventions

herpes simplex thymidine kinaseBIOLOGICAL
ganciclovirDRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed, refractory or relapsed, ovarian epithelial adenocarcinoma, fallopian tube cancer, or extraovarian peritoneal cancer for which no curative therapy exists * Must have tissue available from tumor biopsy to grow tumor cells ex vivo * Must have failed standard therapy with both a platinum agent (cisplatin or carboplatin) and paclitaxel * Site of disease must be less than 5 cm in greatest diameter * Evaluable disease by CT scan, physical exam, or laparoscopy * No significant peritoneal fibrosis either from disease or prior surgery * Surgical lysis of adhesions allowed PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * WBC greater than 2,000/mm3 * Absolute neutrophil count at least 1,000/mm3 * Platelet count at least 50,000/mm3 * Hemoglobin at least 8.5 g/dL (without transfusion) Hepatic: * Bilirubin no greater than 2.0 mg/dL * SGOT or SGPT no greater than 4 times upper limit of normal (ULN) * Alkaline phosphatase no greater than 4 times ULN * Hepatitis B surface antigen test required prior to study if transaminases greater than 2.0 times ULN * No hepatitis B surface antigen * Amylase normal * PT and PTT normal Renal: * Creatinine no greater than 2.0 mg/dL OR * Creatinine clearance at least 50 mL/min Cardiovascular: * No cardiac dysfunction by history and exam * No ischemic heart disease that may be considered anesthetic or operative risk Pulmonary: * No lung disease that may be considered anesthetic or operative risk Other: * HIV negative * Not pregnant or nursing * No acute viral, bacterial, or fungal infection requiring medication within 14 days prior to study * No patient with greater than 2 L of ascites at the time of intraperitoneal infusion * No underlying condition that would preclude compliance * No allergies to study reagent PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * See Disease Characteristics * No concurrent chemotherapy Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * See Disease Characteristics Other: * No concurrent high dose vitamin regimens

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Human Gene Therapy Research Institute

Des Moines, Iowa, 50309, United States

Location

MeSH Terms

Conditions

Fallopian Tube NeoplasmsOvarian NeoplasmsCarcinoma, Ovarian Epithelial

Interventions

Ganciclovir

Condition Hierarchy (Ancestors)

Genital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFallopian Tube DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesEndocrine Gland NeoplasmsOvarian DiseasesEndocrine System DiseasesGonadal DisordersCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

AcyclovirGuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Charles Joseph Link, MD

    John Stoddard Cancer Center at Iowa Methodist Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 6, 2000

First Posted

May 5, 2003

Study Start

June 1, 2000

Last Updated

November 6, 2013

Record last verified: 2003-03

Locations

US(1)