Clinical trial · Interventional
Gene Therapy in Treating Women With Refractory or Relapsed Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cancer
A Phase II Trial of In Vivo Gene Therapy With the Herpes Simplex Thymidine Kinase for the Treatment of Ovarian Cancer
NCT00005025CI-TRIAL-00012584unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Gene therapy may make the body build an immune response to kill tumor cells. PURPOSE: Phase II trial to study the effectiveness of gene therapy in treating women who have refractory or relapsed ovarian epithelial cancer, fallopian tube cancer, or peritoneal cancer.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Primary Peritoneal Cavity Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ganciclovir | Drug | — | UNRESOLVED |
| herpes simplex thymidine kinase | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.