NCT00086866Unknown2 期
Randomized, Open Phase II Study of Immunization With the Recombinant MAGE-3 Protein Combined With Adjuvant AS02B or AS15 in Patients With Unresectable and Progressive Metastatic Cutaneous Melanoma
European Organisation for Research and Treatment of Cancer - EORTC21 个研究点 分布在 7 个国家目标入组 165 人开始时间: 2004年5月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 入组人数
- 165
- 试验地点
- 21
- 主要终点
- Vaccine-related toxicity as assessed by CTCAE v3
研究概览
简要总结
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.
PURPOSE: This randomized phase II trial is studying two different regimens of vaccine therapy and comparing them to see how well they work in treating patients with stage III or stage IV melanoma that cannot be removed with surgery.
详细描述
OBJECTIVES:
Primary
- Compare the objective response rate (complete and partial response) in patients with unresectable stage III or stage IV M1a cutaneous melanoma immunized with vaccine comprising D1/3-MAGE-3-His fusion protein and SB-AS02B adjuvant vs SB-AS15 adjuvant.
- Compare the activity of SB-AS02B adjuvant vs SB-AS15 adjuvant, in terms of maximizing the antigenicity of MAGE-3, in patients treated with these regimens.
- Compare the rate of grade 3/4 vaccine-related toxicity in patients treated with these regimens.
Secondary
- Compare progression-free survival in patients treated with these regimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed cutaneous melanoma
- •Unresectable stage III OR stage IV M1a disease
- •Documented progressive disease within the past 12 weeks
- •Measurable disease
- •Skin, soft tissue, or lymph node metastasis allowed provided the disease is not amenable to curative treatment with surgery
- •Tumor must express the MAGE-3 gene by reverse transcription polymerase chain reaction analysis (more than 1% of the positive MAGE-3 control included in the assay)
- •No visceral metastases within the past 56 days by imaging
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Hemoglobin ≥ lower limit of normal (LLN)
- •WBC ≥ LLN
- •Lymphocyte count ≥ LLN
- •Platelet count ≥ LLN
- •No bleeding disorders
- •Bilirubin ≤ upper limit of normal (ULN)
- •Lactic dehydrogenase ≤ ULN
- •AST and ALT ≤ 2 times ULN
- •PT and aPTT normal
- •Hepatitis B surface antigen negative (antibody test may be positive)
- •Hepatitis C antibody negative
- •Creatinine ≤ ULN
- •Cardiovascular
- •No clinically significant heart disease (CTC grade III or IV)
- •Immunologic
- •No autoimmune disease (vitiligo allowed)
- •No anti-nuclear antibody titer ≥ 1/320 OR equal to 1/160 AND auto-antibodies directed against specific auto-antigens
- •No immunodeficiency
- •No active infection requiring antibiotic therapy
- •HIV negative
- •Not pregnant
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 3 months after study participation
- •No other malignancy within the past 5 years except surgically cured basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- •No other serious acute or chronic illness requiring concurrent medications
- •No psychological, familial, sociological, or geographical condition that would preclude study compliance
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •More than 8 weeks since prior adjuvant vaccine therapy
- •No prior vaccine therapy containing a MAGE-3 antigen
- •No prior vaccine therapy for metastatic melanoma
- •No concurrent immunomodulating agents (e.g., BCG)
- •Chemotherapy
- •No prior systemic chemotherapy
- •No concurrent chemotherapy
- •Endocrine therapy
- 另有 15 项未显示
排除标准
- 未提供
结局指标
主要结局
Vaccine-related toxicity as assessed by CTCAE v3
Response rate (complete response and partial response) as assessed by RECIST criteria
次要结局
- Rate of stabilization as assessed by RECIST criteria
- Rate of immune response
- Rate of mixed response as assessed by RECIST criteria
- Progression-free survival
研究者
研究点 (21)
Loading locations...
相似试验
已完成
2 期
PSA Vaccine Therapy in Treating Patients With Advanced Prostate CancerProstate CancerNCT00003871Eastern Cooperative Oncology Group60
Unknown
1 期
Vaccine Therapy in Treating Patients Who Have Stage II, Stage III, or Stage IV MelanomaMelanoma (Skin)NCT00010309Genzyme, a Sanofi Company
Unknown
2 期
Vaccine Therapy and Chemotherapy With or Without Tetanus Toxoid Compared With Chemotherapy Alone in Treating Patients With Metastatic Colorectal CancerColorectal CancerNCT00027833Herbert Irving Comprehensive Cancer Center
已完成
2 期
Vaccine Therapy in Treating Patients With Recurrent Soft Tissue SarcomaSarcomaNCT00005628Memorial Sloan Kettering Cancer Center
已完成
2 期
Vaccine Therapy in Treating Patients With Colorectal Cancer Metastatic to the LiverMetastatic CancerColorectal CancerNCT00033748Alliance for Clinical Trials in Oncology56