Vaccination Of Prostate Cancer Patients With A Bivalent Vaccine Containing MUC-2 Glycopeptide And Globo H Conjugates: A Dose-Escalating Trial Studying The Immunogenicity And Safety Of The Immunological Adjuvant GPI-0100
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- safety
研究概览
简要总结
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Combining vaccine therapy with biological therapy may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness in combining vaccine therapy and biological therapy in treating patients who have relapsed prostate cancer.
详细描述
OBJECTIVES:
- Determine the optimal (in terms of antibody response) and safe dose range of glycosylated MUC-2-Globo H-KLH conjugate vaccine with adjuvant GPI-0100 in patients with biochemically relapsed prostate cancer.
- Assess post-immunization changes in prostate-specific antigen levels and other objective parameters of disease in these patients.
OUTLINE: This is a dose-escalation study of GPI-0100.
Patients receive glycosylated MUC-2-Globo H-KLH conjugate vaccine with adjuvant GPI-0100 subcutaneously weekly on weeks 0-2, 6, 14, and 26 in the absence of unacceptable toxicity or disease progression.
Cohorts of 5 patients receive escalating doses of GPI-0100 until the optimal dose, based on antibody response, is reached.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed prostate cancer
- •Biochemically progressive disease after primary surgery or radiotherapy with or without neoadjuvant androgen ablation
- •Greater than 50% increase in PSA level above baseline value of 1.0 ng/mL post-prostatectomy or 2.0 ng/mL post-radiotherapy, based on 3 successive determinations taken at 2-week intervals
- •Patients with prior intermittent hormonal therapy and non-castrate levels of testosterone are eligible
- •Evaluable disease
- •No radiographic evidence of metastasis
- •No active CNS or epidural tumor
- •No soft tissue and/or bone disease
- •No androgen-independence with no evidence of radiographic disease
- •May not be symptomatic or anticipated to develop symptoms within 6 months of study entry
- •Concurrent registration to protocol MSKCC-90-040 required
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Karnofsky 70-100%
- •Life expectancy:
- •At least 6 months
- •Hematopoietic:
- •WBC at least 3,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin less than 2.0 mg/dL OR
- •SGOT less than 3 times upper limit of normal
- •Creatinine no greater than 2.0 mg/dL OR
- •Creatinine clearance at least 40 mL/min
- •Cardiovascular:
- •No clinically significant cardiac disease (New York Heart Association class III or IV)
- •No severe debilitating pulmonary disease
- •No other prior malignancy within the past 5 years except nonmelanoma skin cancer
- •No positive stool guaiac except hemorrhoids or history of documented radiation-induced proctitis
- •No narcotic-dependent pain
- •No infection requiring antibiotics
- •No requirement for immunosuppressive therapy
- •No allergy to seafood
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •At least 4 weeks since prior chemotherapy
- •Endocrine therapy:
- •See Disease Characteristics
- •At least 2 weeks since change in hormonal therapy (except to maintain castrate levels of testosterone), including prednisone or dexamethasone
- •At least 8 weeks since prior suramin and/or documented plasma concentration
- •of suramin is less than 50 micrograms/mL (replacement hydrocortisone allowed)
- •Radiotherapy:
- •See Disease Characteristics
- •At least 4 weeks since prior radiotherapy
- •No concurrent radiotherapy to only measurable lesion
- •See Disease Characteristics
- •No concurrent surgery of only measurable lesion
- 另有 3 项未显示
排除标准
- 未提供
研究组 & 干预措施
vaccine
This is a dose-escalation study of GPI-0100.
Patients receive glycosylated MUC-2-Globo H-KLH conjugate vaccine with adjuvant GPI-0100 subcutaneously weekly on weeks 0-2, 6, 14, and 26 in the absence of unacceptable toxicity or disease progression.
Cohorts of 5 patients receive escalating doses of GPI-0100 until the optimal dose, based on antibody response, is reached.
Patients are followed every 3 months.
干预措施: MUC-2-Globo H-KLH conjugate vaccine (Biological)
vaccine
This is a dose-escalation study of GPI-0100.
Patients receive glycosylated MUC-2-Globo H-KLH conjugate vaccine with adjuvant GPI-0100 subcutaneously weekly on weeks 0-2, 6, 14, and 26 in the absence of unacceptable toxicity or disease progression.
Cohorts of 5 patients receive escalating doses of GPI-0100 until the optimal dose, based on antibody response, is reached.
Patients are followed every 3 months.
干预措施: GPI-0100 (Biological)
结局指标
主要结局
safety
时间窗: 2 years
次要结局
- immune function(2 years)