A Phase I Study of Ad-p53 (NSC# 683550) for Patients With Platinum- and Paclitaxel-Resistant Epithelial Ovarian Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
研究概览
简要总结
Phase I trial to study the effectiveness of gene therapy in treating patients with ovarian cancer that has not responded to previous treatment. Inserting the p53 gene into a person's cancer cells may improve the body's ability to fight cancer or make the cancer cells more sensitive to treatment.
详细描述
OBJECTIVES:
I. Determine the maximum tolerated doses of adenovirus p53 in patients with platinum- and paclitaxel-resistant ovarian epithelial cancer.
II. Determine the qualitative and quantitative toxic effects of this regimen in these patients.
III. Document the observed anti-tumor activity of this regimen in these patients.
IV. Evaluate the biological endpoints (e.g., induction of apoptosis, p53 expression) of this regimen in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 metastatic ovarian epithelial cancer that is platinum- and paclitaxel resistant as defined by: Disease progression while on first-line regimen containing both a platinum drug and paclitaxel OR Tumor progression within 6 months of completion of platinum-based therapy (either as first- or second-line) or paclitaxel-based therapy (either as first- or second-line)
- •Refractory or recurrent ovarian epithelial cancer as defined by: Lesions of any diameter
- •Nonmeasurable disease (with CA-125 at least 35)
- •Ascites and/or pleural effusions allowed
- •No borderline or low malignant potential tumors
- •PATIENT CHARACTERISTICS:
- •Age: 18 and over
- •Performance status: Zubrod 0-2
- •Life expectancy: At least 12 weeks
- •WBC at least 3,000/mm3
- •Granulocyte count at least 1,500/mm3
- •Platelet count at least 100,000/mm3
- •Bilirubin no greater than 1.5 mg/dL PT/PTT normal
- •Creatinine no greater than 1.4 mg/dL
- •No active, unresolved upper respiratory infections
- •Not HIV positive
- •At least 5 years since prior malignancy, except nonmelanomatous skin cancer
- •Willing and able to undergo placement of Tenckhoff catheter in the peritoneal cavity for sampling of ascites or peritoneal fluid
- •No concurrent serious medical illness
- •No untreated gastrointestinal obstruction
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •May have failed an unlimited number of prior chemotherapy regimens
- •At least 30 days since prior chemotherapy
- •No prior radiotherapy to the pelvis or abdomen
- •Eligible for laparoscopy
排除标准
- 未提供
研究组 & 干预措施
Arm I
Patients undergo laparoscopy for p53 assessment and catheter placement. Patients receive daily intraperitoneal injections of adenovirus p53 (Ad-p53) for 5 days every 3 weeks. Treatment is repeated every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients each are treated at each dose level of Ad-p53. The maximum tolerated dose is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicity.
干预措施: Ad5CMV-p53 gene (Biological)
Arm I
Patients undergo laparoscopy for p53 assessment and catheter placement. Patients receive daily intraperitoneal injections of adenovirus p53 (Ad-p53) for 5 days every 3 weeks. Treatment is repeated every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients each are treated at each dose level of Ad-p53. The maximum tolerated dose is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicity.
干预措施: laparoscopic surgery (Procedure)