A Feasibility and Toxicity Study of a Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) Secreting Allogeneic Melanoma Vaccine Administered Alone or in Combination With Cyclophosphamide in Subjects With Surgically Resected At-Risk Melanoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability of Administering Melanoma GVAX With and Without Cyclophosphamide
研究概览
简要总结
The primary objective of this study is to evaluate the safety and feasibility of administering an allogeneic GM-CSF-secreting lethally irradiated whole melanoma cell vaccine ("melanoma GVAX"), alone or in combination with low dose cyclophosphamide (CPM), for the adjuvant treatment of patients with surgically resected stage IIB-IV melanoma. Secondarily, the investigators will assess in vitro correlates of anti-melanoma immunization by melanoma GVAX, including serological and cellular immune responses in patients treated with either the vaccine alone or the vaccine given with low dose CPM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Any patient age ≥18 years with melanoma of cutaneous or mucosal origin, and with clinicopathologic stage IIB, IIC, III or IV that has been completely resected
- •Patients must be able to provide informed consent.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Life expectancy of at least 6 months.
- •Adequate hematologic function.
- •Adequate renal function
- •Adequate hepatic function
- •Patients of both genders must agree to practice effective birth control during the study period and for at least 4 weeks after the last treatment.
排除标准
- •Patients whose primary site of melanoma is ocular.
- •Are undergoing or have undergone in the past 4 weeks any systemic treatment for melanoma.
- •Are undergoing or have undergone in the past 2 weeks any surgery or focal radiation therapy.
- •Have active systemic infections, coagulation disorders (including therapeutic anticoagulation), or other major medical or psychiatric illnesses.
- •Are known to be positive for hepatitis B surface antigen, anti-Hepatitis C Virus or anti-Human Immunodeficiency Virus (HIV) antibody (because of possible immune effects of these conditions).
- •Documented history of autoimmune disease, for example, systemic lupus erythematosus, sarcoidosis, rheumatoid arthritis, glomerulonephritis, or vasculitis.
- •Any form of primary or secondary immunodeficiency. This would include hereditary disorders such as ataxia-telangiectasia or Wiskott-Aldrich syndrome, or acquired immune deficiencies such as following bone marrow transplantation.
- •Requirement for systemic steroid therapy or immunosuppressive therapy.
- •Have received any type of cancer immunotherapy, including but not limited to interleukin-2, interferon alfa or melanoma vaccines.
- •Have been diagnosed with another invasive cancer within the past 3 years.
- •Radiographic evidence of melanoma recurrence.
- •Pregnant or lactating women.
- •Known or suspected hypersensitivity to GM-CSF, pentastarch, hetastarch, corn, Dimethyl sulfoxide, fetal bovine serum or trypsin (porcine origin).
研究组 & 干预措施
Cohort A
Cohort A will receive four doses of vaccine, each containing 5E7 melanoma GVAX cells.
干预措施: melanoma GVAX (Biological)
Cohort B
Cohort B will receive four doses of vaccine, each containing 2E8 melanoma GVAX cells.
干预措施: melanoma GVAX (Biological)
Cohort C
Cohort C will receive four doses of vaccine, each containing 2E8 melanoma GVAX cells. One day prior to each vaccination, patients in cohort C will receive a single, low dose of intravenous cyclophosphamide.
干预措施: melanoma GVAX (Biological)
Cohort C
Cohort C will receive four doses of vaccine, each containing 2E8 melanoma GVAX cells. One day prior to each vaccination, patients in cohort C will receive a single, low dose of intravenous cyclophosphamide.
干预措施: Cyclophosphamide (Drug)
结局指标
主要结局
Number of Participants with Adverse Events as a Measure of Safety and Tolerability of Administering Melanoma GVAX With and Without Cyclophosphamide
时间窗: 2.5 years
To determine the side effects and tolerability of administering an allogeneic GM-CSF-secreting lethally irradiated whole melanoma cell vaccine ("melanoma GVAX"), alone or in combination with low dose cyclophosphamide, for the adjuvant treatment of patients with surgically resected stage IIB-IV melanoma.
次要结局
- In vitro correlates of anti-melanoma immunization(2.5 Years)