Pilot Phase II Trial for the Evaluation of the Effect of Systemic Low-dose IL-2 on the Immunogenicity of a Vaccine Comprising Synthetic Melanoma Peptides Administered With GM-CSF-in-Adjuvant, in Patients With High Risk Melanoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 41
- 主要终点
- To evaluate the effect of systemic low-dose IL-2 on the immunogenicity of a vaccine comprising synthetic melanoma peptides plus GM-CSF-in-adjuvant.
研究概览
简要总结
This clinical pilot study will test the hypothesis that systemic low-dose IL-2 therapy significantly enhances the immunologic efficacy of a vaccine comprising melanoma peptides plus GM-CSF-in-adjuvant.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have been diagnosed, by cytologic or histologic examination, with AJCC stage IIB, stage III or resected stage IV melanoma.
- •Patients with up to 2 brain metastases less than or equal to 2 cm that have been surgically removed or treated successfully with the gamma-knife are eligible. Surgical resections must have been performed within 6 months prior to entry.
- •All patients must have:
- •ECOG performance status 0-1, and,
- •Ability and willingness to give informed consent.
- •Laboratory parameters as follows:
- •HLA-A1, A2 or A3 (+)
- •gp100 (+) and/or tyrosinase (+) tumor cells
- •ANC > 1000/mm3, and Platelets > 100,000 and Hgb > 9
- •Hepatic: AST and ALT up to 2.5 x upper limits of normal (ULN), Bilirubin up to 2.5 x ULN, Alkaline phosphatase up to 2.5 x ULN
- •Renal: Creatinine up to 1.5 x ULN
- •Serology: HIV negative, Hepatitis C negative
- •Exclusion criteria:
- •Patients who are currently receiving cytotoxic Chemotherapy or radiation or who have received that therapy within the preceding 4 weeks.
- •Patients with known or suspected allergies to any component of the vaccine.
- •Patients receiving the following medications at study entry or within the preceding 30 days are excluded:
- •Agents with putative immunomodulating activity (with the exception of non-steroidal anti-inflammatory agents)
- •Allergy desensitization injections
- •Corticosteroids, administered parenterally or orally - topical corticosteroids are acceptable
- •Any growth factors, Interleukin 2, Interferon alfa.
- •Prior melanoma vaccinations will not be an exclusion criteria if given more than 8 weeks previously, but will be recorded, and data analysis will take this into account.
- •Other investigational drugs or investigational therapy also will not necessarily be an exclusion criteria, but will similarly be recorded and taken into account during data analysis.
- •Pregnancy or the possibility of becoming pregnant during vaccine administration.
- •Female patients of child-bearing potential must have a negative pregnancy test (urinary or serum beta-HCG) prior to administration of the first vaccine dose.
- •Males and females must agree, in the consent form, to use effective birth control methods during the course of vaccination.
- •This is consistent with existing standards of practice for vaccine and chemotherapy protocols.
- •Patients in whom there is a medical contraindication or potential problem in complying with the requirements of the protocol, in the opinion of the investigator.
- •Patients classified according to the New York Heart Association classification system as having Class II, III or IV heart disease.
- •Patients with active connective tissue disease requiring medication, or other severe autoimmune disease.
- •Patients who are actively hyperthyroid.
- •Patients with uncontrolled diabetes.
排除标准
- 未提供
研究组 & 干预措施
Peptides with GM-CSF-in-adjuvant, with upfront IL-2
Each of the peptides plus tetanus toxoid peptide, plus GM-CSF in adjuvant, administered subcutaneously and intradermally. Systemic low-dose IL-2 will be administered daily for 6 weeks, beginning at week 1 and ending at week 7.
干预措施: low-dose IL-2 (Drug)
Peptides with GM-CSF-in-adjuvant, with upfront IL-2
Each of the peptides plus tetanus toxoid peptide, plus GM-CSF in adjuvant, administered subcutaneously and intradermally. Systemic low-dose IL-2 will be administered daily for 6 weeks, beginning at week 1 and ending at week 7.
干预措施: melanoma vaccine (Biological)
Peptides plus GM-CSF-in-adjuvant, delayed IL-2
Peptides plus GMCSF-in-adjuvant, with delayed IL-2.
Each of the peptides plus tetanus toxoid peptide, plus GM-CSF in adjuvant, administered subcutaneously and intradermally. Systemic low-dose IL-2 will be administered daily for 6 weeks, beginning at week 4 and ending at week 10.
干预措施: low-dose IL-2 (Drug)
Peptides plus GM-CSF-in-adjuvant, delayed IL-2
Peptides plus GMCSF-in-adjuvant, with delayed IL-2.
Each of the peptides plus tetanus toxoid peptide, plus GM-CSF in adjuvant, administered subcutaneously and intradermally. Systemic low-dose IL-2 will be administered daily for 6 weeks, beginning at week 4 and ending at week 10.
干预措施: melanoma vaccine (Biological)
结局指标
主要结局
To evaluate the effect of systemic low-dose IL-2 on the immunogenicity of a vaccine comprising synthetic melanoma peptides plus GM-CSF-in-adjuvant.
次要结局
- Changes in disease, analysis of melanoma antigen (gp100, tyrosinase, MART-1) expression on melanoma cells from metastatic sites, Vitiligo.