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
Maladies génito-urinaires+18
+ Maladies Génitales
+ Maladies Annexielles
Étude thérapeutique
Résumé
Date de début de l'étude : 1 juin 2000
Date à laquelle le premier participant a commencé l'étude.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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Femme
Le sexe biologique des participants éligibles à s'inscrire.À partir de 18 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
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
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site
Human Gene Therapy Research Institute
Des Moines, United StatesOuvrir Human Gene Therapy Research Institute dans Google Maps