NCT00042783已完成2 期
A Phase II Trial Of A D1/3-MAGE3-HIS Fusion Protein (NSC-719274) With Adjuvant SBAS02B (NSC-719275) For Patients With Stage IV, M1a or M1b Metastatic Melanoma
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 7
研究概览
简要总结
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Vaccine therapy may be effective in treating stage IV melanoma.
PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients who have stage IV melanoma.
详细描述
OBJECTIVES:
- Determine the feasibility of treating patients with stage IV melanoma with D1/3-MAGE-3-His fusion protein with SB-AS02B adjuvant.
- Determine the clinically confirmed response rates (partial and complete responses) of patients treated with this regimen.
- Determine the 6-month progression-free survival rate of patients treated with this regimen.
- Determine the qualitative and quantitative toxic effects of this regimen in these patients.
- Determine immune responses in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive D1/3-MAGE-3-His fusion protein emulsified in SB-AS02B adjuvant intramuscularly once every 3 weeks for a total of 12 weeks (4 injections). In the absence of disease progression or unacceptable toxicity, patients receive a second 12-week course beginning at week 16.
Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed stage IV melanoma that is considered incurable by surgery, radiotherapy, or limb perfusion
- •M1a or M1b disease
- •Measurable disease outside prior field of limb perfusion
- •Metastatic mucosal melanoma allowed
- •MAGE-3 positive by reverse transcription polymerase chain reaction
- •No uveal or choroidal primary melanoma
- •No prior or concurrent brain metastases by CT scan or MRI of the brain
- •PATIENT CHARACTERISTICS:
- •Not specified
- •Performance status
- •Zubrod 0-1
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Not specified
- •Hepatitis B surface antigen negative
- •Hepatitis C negative
- •No liver cirrhosis
- •No unstable liver disease
- •No coagulation disorders
- •Not specified
- •Cardiovascular
- •No major cardiovascular illness
- •No myocardial infarction within the past 6 months
- •No major pulmonary illness
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •HIV negative
- •No AIDS or HIV-1-associated complex
- •No chronic alcohol abuse or drug addiction
- •No systemic infections
- •No prior active autoimmune disease
- •No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer from which the patient is currently disease-free
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •At least 4 weeks since prior adjuvant biologic therapy
- •No prior biologic therapy for stage IV melanoma
- •No prior MAGE-3 peptide or protein vaccine preparation
- •Chemotherapy
- •At least 4 weeks since prior adjuvant chemotherapy
- •No prior chemotherapy for stage IV melanoma
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •At least 4 weeks since prior adjuvant radiotherapy
- •At least 4 weeks since prior surgery
- •See Disease Characteristics
- •At least 3 weeks since prior limb perfusion and recovered
- •At least 4 weeks since other prior adjuvant therapy
- 另有 1 项未显示
排除标准
- 未提供
研究者
研究点 (7)
Loading locations...
相似试验
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
终止
2 期
Vaccine Therapy, Trastuzumab, and Vinorelbine in Treating Women With Locally Recurrent or Metastatic Breast CancerBreast CancerNCT00088985UNC Lineberger Comprehensive Cancer Center56
终止
2 期
Phase II Study of Allo LMI Vaccine With IL-2 for Stable Metastatic Breast CaBreast CancerNCT00784524Masonic Cancer Center, University of Minnesota14
已完成
2 期
Vaccine Therapy in Treating Patients With Metastatic Melanoma of the EyeExtraocular Extension MelanomaRecurrent Intraocular MelanomaNCT00020475National Cancer Institute (NCI)