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

Brief Title

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

Official Title

A Phase II Trial of In Vivo Gene Therapy With the Herpes Simplex Thymidine Kinase for the Treatment of Ovarian Cancer

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.

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 Phase

Phase 2

Study Type

Interventional

Condition

Fallopian Tube Cancer

Intervention

herpes simplex thymidine kinase

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Biological

Start Date

June 2000

Eligibility 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

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Charles Joseph Link, MD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT00005025

Organization ID

CDR0000067546

Secondary IDs

HGTRI-0105

Study Sponsor

John Stoddard Cancer Center at Iowa Methodist Medical Center

Study Sponsor

Charles Joseph Link, MD, Study Chair, John Stoddard Cancer Center at Iowa Methodist Medical Center

Verification Date

March 2003