Phase II Study of Allovectin-7 as an Immunotherapeutic Agent in Patients With Stages III and IV Melanoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Vical
- 入组人数
- 78
- 试验地点
- 6
研究概览
简要总结
RATIONALE: Injecting allovectin-7 into a person's melanoma cells may make the body build an immune response that will kill tumor cells.
PURPOSE: Phase II trial to study the effectiveness of gene therapy in treating patients who have stage III or stage IV melanoma that has not responded to previous treatment.
详细描述
OBJECTIVES: I. Demonstrate an objective clinical response (partial or complete) with a median duration of at least 4 months in 15% of patients with stage III or IV melanoma treated with Allovectin-7. Allovectin-7 is a direct gene transfer immunotherapeutic agent.
II. Determine the benefits, risks, and side effects of Allovectin-7 in this patient population.
PROTOCOL OUTLINE: This is a multicenter study. Patients receive an intratumoral injection of Allovectin-7 once weekly for 6 weeks. At week 9, a complete disease status assessment is performed. Patients with stable or responding disease may receive additional courses of 6 injections.
PROJECTED ACCRUAL:
A total of 70 patients will be accrued for this study.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 接受健康志愿者
- 否
入选标准
- •PROTOCOL ENTRY CRITERIA:
- •-Disease Characteristics--
- •Histologically confirmed melanoma; Stage III with locoregional disease, in transit metastasis, or nodal disease OR Stage IV metastatic disease in skin, subcutaneous tissue, lymph node(s), and/or lung
- •At least 1 metastasis for which surgery is not deemed to be a curative option
- •Relapsed from or has not responded to frontline chemotherapy or biotherapy
- •At least 1 measurable tumor at least 1 cm by 1 cm, but less than 5 cm by 5 cm
- •No history of brain metastases or visceral metastases other than lung metastases
- •-Prior/Concurrent Therapy--
- •Biologic therapy: See Disease Characteristics; At least 4 weeks since prior biologic therapy
- •Chemotherapy: See Disease Characteristics; At least 4 weeks since prior chemotherapy
- •Endocrine therapy: No concurrent immunosuppressive drugs
- •Radiotherapy: At least 4 weeks since prior radiotherapy
- •Surgery: At least 2 weeks since prior major surgery
- •Other: No other concurrent anticancer drug therapy, or any other experimental therapy
- •-Patient Characteristics--
- •Age: 18 and over
- •Performance status: Karnofsky 80-100%
- •Life expectancy: At least 6 months
- •Hematopoietic: WBC at least 3,000/mm3; Platelet count at least 100,000/mm3; Hemoglobin at least 9 g/dL
- •Hepatic: Bilirubin no greater than 2.0 mg/dL; SGOT/SGPT less than 3 times upper limit of normal; PT/PTT normal LDH and albumin normal
- •Renal: Creatinine no greater than 2.0 mg/dL
- •Cardiovascular: No uncontrolled hypertension; No New York Heart Association class III or IV disease
- •Other: HIV negative; Negative pregnancy test; Fertile patients must use effective contraception; No active autoimmune disease; No active infection requiring parenteral antibiotics; No uncontrolled diabetes mellitus; No other prior malignancy in the past 5 years except skin cancer or stage 0-II cervical cancer; No significant psychiatric disorders
排除标准
- 未提供