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

Fecha de inicio: 1 de junio de 2000

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