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

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