NCT00005025Unknown2 期
A Phase II Trial of In Vivo Gene Therapy With the Herpes Simplex Thymidine Kinase for the Treatment of Ovarian Cancer
John Stoddard Cancer Center at Iowa Methodist Medical Center2 个研究点 分布在 1 个国家开始时间: 2000年6月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 试验地点
- 2
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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:
- •18 and over
- •Performance status:
- •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)
- •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
- •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
- •No lung disease that may be considered anesthetic or operative risk
- •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
- •See Disease Characteristics
- •No concurrent high dose vitamin regimens
排除标准
- 未提供
研究者
研究点 (2)
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