A Phase II Trial of In Vivo Gene Therapy With the Herpes Simplex Thymidine Kinase for the Treatment of Ovarian Cancer
herpes simplex thymidine kinase
+ ganciclovir
Urogenital Diseases+18
+ Genital Diseases
+ Adnexal Diseases
Treatment Study
Summary
Study start date: June 1, 2000
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Human Gene Therapy Research Institute
Des Moines, United StatesOpen Human Gene Therapy Research Institute in Google Maps