Phase III Randomized Study of Dacarbazine With or Without Allovectin-7 in Patients With Metastatic Melanoma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Vical
- 试验地点
- 88
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Injecting allovectin-7 into a person's melanoma cells may make the body build an immune response that will kill tumor cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of dacarbazine with or without immunotherapy in treating patients who have stage III or stage IV melanoma.
详细描述
OBJECTIVES: I. Demonstrate either an improvement in the median time to disease progression by at least 2 months with no decrease in the rate of objective clinical response OR an improvement by at least 15% in the rate of objective clinical response with no decrease in the median time to disease progression in patients with stage III or IV melanoma receiving dacarbazine with Allovectin-7 when compared with patients receiving dacarbazine alone.
II. Determine the benefits, risks, and side effects of these regimens in this patient population.
PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are stratified according to sex, age, and spread of disease (cutaneous or nodal vs visceral disease). Patients are randomized to one of two treatment arms.
Arm I: Patients receive dacarbazine IV over 1 hour on day 0. Arm II: Patients receive treatment as in arm I. Patients also receive Allovectin-7 intratumorally on days 3 and 10.
Patients with stable or responding disease may receive additional courses every 28 days.
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）
- 接受健康志愿者
- 否
入选标准
- •PROTOCOL ENTRY CRITERIA:
- •-Disease Characteristics--
- •Histologically confirmed stage III or IV melanoma 1 or more metastatic tumors for which surgery is not deemed to be a curative option
- •Dacarbazine is indicated as first line chemotherapy
- •At least 1 measurable tumor at least 1 cm2 but no greater than 100 cm2
- •No history of brain metastases
- •-Prior/Concurrent Therapy--
- •Biologic therapy: At least 4 weeks since prior biologic therapy
- •Chemotherapy: See Disease Characteristics; No 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 experimental therapy
- •-Patient Characteristics--
- •Age: 18 and over
- •Performance status: Karnofsky 80-100%
- •Life expectancy: At least 24 weeks
- •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 (ULN); PT/PTT normal; Albumin normal; LDH no greater than 2 times ULN
- •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; Not pregnant or nursing; 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 within the past 5 years except skin cancer or stage 0-II cervical cancer; No significant psychiatric disorders
排除标准
- 未提供