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Gene Therapy in Treating Women With Refractory or Relapsed Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2003 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: April 6, 2000
Last updated: November 5, 2013
Last verified: March 2003

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.

Condition Intervention Phase
Fallopian Tube Cancer
Ovarian Cancer
Primary Peritoneal Cavity Cancer
Biological: herpes simplex thymidine kinase
Drug: ganciclovir
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase II Trial of In Vivo Gene Therapy With the Herpes Simplex Thymidine Kinase for the Treatment of Ovarian Cancer

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: June 2000
Detailed Description:


  • Determine the efficacy and safety of in vivo gene therapy with herpes simplex thymidine kinase (HSVtk) vector producer cells (VPC) followed by ganciclovir in women with refractory or relapsed ovarian epithelial adenocarcinoma, fallopian tube cancer, or peritoneal cancer.
  • Determine any development of systemic immunity to this regimen or tumor in these patients.
  • Determine the toxic effects of intraperitoneal HSVtk VPC in these patients.

OUTLINE: All patients receive an intraperitoneal catheter prior to infusion.

Patients receive herpes simplex thymidine kinase (HSVtk) vector producer cells (VPC) IP over 15-60 minutes on day 0, followed by ganciclovir IV 2 times daily on days 28-41. Treatment repeats for up to 3 courses in patients with stable or responsive disease.

Patients are followed every 3 months for 1 year.

PROJECTED ACCRUAL: A total of 14-20 patients will be accrued for this study within 18-24 months.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified


  • 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)


  • 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


  • Creatinine no greater than 2.0 mg/dL OR
  • Creatinine clearance at least 50 mL/min


  • No cardiac dysfunction by history and exam
  • No ischemic heart disease that may be considered anesthetic or operative risk


  • No lung disease that may be considered anesthetic or operative risk


  • 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


Biologic therapy:

  • Not specified


  • See Disease Characteristics
  • No concurrent chemotherapy

Endocrine therapy:

  • Not specified


  • Not specified


  • See Disease Characteristics


  • No concurrent high dose vitamin regimens
  Contacts and Locations
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Please refer to this study by its identifier: NCT00005025

United States, Iowa
Human Gene Therapy Research Institute
Des Moines, Iowa, United States, 50309
Sponsors and Collaborators
John Stoddard Cancer Center at Iowa Methodist Medical Center
Study Chair: Charles Joseph Link, MD John Stoddard Cancer Center at Iowa Methodist Medical Center
  More Information Identifier: NCT00005025     History of Changes
Other Study ID Numbers: CDR0000067546
Study First Received: April 6, 2000
Last Updated: November 5, 2013

Keywords provided by National Cancer Institute (NCI):
recurrent ovarian epithelial cancer
fallopian tube cancer
primary peritoneal cavity cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Fallopian Tube Neoplasms
Peritoneal Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Antiviral Agents
Anti-Infective Agents processed this record on May 25, 2017