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 because the information has not been verified recently.
Verified March 2003 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00005025
First received: April 6, 2000
Last updated: November 5, 2013
Last verified: March 2003
  Purpose

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:

OBJECTIVES:

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00005025

Locations
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
Investigators
Study Chair: Charles Joseph Link, MD John Stoddard Cancer Center at Iowa Methodist Medical Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00005025     History of Changes
Other Study ID Numbers: CDR0000067546, HGTRI-0105, NCI-V00-1584
Study First Received: April 6, 2000
Last Updated: November 5, 2013
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on October 20, 2014