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

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ClinicalTrials.gov Identifier: NCT00005025
Recruitment Status : Unknown
Verified March 2003 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : May 5, 2003
Last Update Posted : November 6, 2013
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Study Description
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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.


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

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
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
Study Start Date : June 2000

Resource links provided by the National Library of Medicine

Drug Information available for: Ganciclovir

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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ClinicalTrials.gov Identifier: NCT00005025     History of Changes
Other Study ID Numbers: CDR0000067546
HGTRI-0105
NCI-V00-1584
First Posted: May 5, 2003    Key Record Dates
Last Update Posted: November 6, 2013
Last Verified: March 2003

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
Neoplasms
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
Ganciclovir
Antiviral Agents
Anti-Infective Agents