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


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Charles Joseph Link, MD

Investigator Role:

Study Chair

Investigator Affiliation:

John Stoddard Cancer Center at Iowa Methodist Medical Center

Authority:

United States: Federal Government

Study ID:

CDR0000067546

NCT ID:

NCT00005025

Start Date:

June 2000

Completion Date:

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • recurrent ovarian epithelial cancer
  • fallopian tube cancer
  • primary peritoneal cavity cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms
  • Neoplasms, Glandular and Epithelial

Name

Location

Human Gene Therapy Research InstituteDes Moines, Iowa  50309