NCT00091338已完成1 期
A Study of Subcutaneous "CYT 99 007" (Interleukin-7) in Conjunction With Peptide Immunization in Patients With Metastatic Melanoma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Interleukin-7 may stimulate a person's white blood cells to kill tumor cells. Vaccines made from peptides may make the body build an immune response to kill tumor cells. Combining interleukin-7 with vaccine therapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of interleukin-7 when given with vaccine therapy in treating patients with metastatic melanoma.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of interleukin-7 (IL-7) when administered with melanoma peptide vaccine emulsified in Montanide ISA-51 in patients with metastatic melanoma.
- Determine the safety of this regimen in these patients.
Secondary
- Determine the biological effects of this regimen on T-cell function and phenotype at various doses and at the optimal biological dose in these patients.
- Determine the pharmacokinetic and pharmacodynamic characteristics of IL-7 in patients treated with this regimen.
- Determine the antitumor effects of IL-7, in terms of a dose-escalation strategy, in these patients.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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 melanoma
- •Metastatic disease
- •Measurable or evaluable disease
- •Disease progression during or after prior interleukin-2 (IL-2) OR ineligible to receive high-dose IL-2* OR has disease burden for which IL-2 is not indicated* NOTE: *If patient did not receive prior IL-2, must have progressed after prior standard first-line therapy (e.g., metastasectomy for single lesions or dacarbazine)
- •HLA-A*0201-positive disease
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •At least 3 months
- •Hematopoietic
- •Absolute neutrophil count > 1,000/mm^3*
- •Absolute lymphocyte count ≥ 200/mm^3*
- •Platelet count > 100,000/mm^3
- •No proliferative hematologic disease NOTE: *For 2 consecutive readings performed on 2 different days
- •AST and ALT < 3 times upper limit of normal (ULN)
- •PT/PTT ≤ 1.5 times ULN
- •Hepatitis B negative
- •Positive hepatitis B serology indicative of prior immunization (i.e., positive for antibody against hepatitis B surface antigen AND negative for antibody against hepatitis B core antigen) allowed
- •Hepatitis C negative
- •Creatinine ≤ 1.4 mg/dL
- •Cardiovascular
- •Ejection fraction > 45% by MUGA for patients ≥ 50 years of age OR with a history of cardiac disease
- •No resting blood pressure > 140/90 mm Hg with standard antihypertensive therapy
- •DLCO/VA and FEV_1 > 50% of predicted on pulmonary function test for smokers OR for patients with clinical evidence of compromised pulmonary function
- •No history of severe asthma
- •Immunologic
- •HIV negative
- •No history of autoimmune disease
- •No splenomegaly
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No other medical or psychiatric disease that would preclude study participation
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •See Disease Characteristics
- •More than 4 weeks since prior cytokines
- •No prior allogeneic hematopoietic stem cell transplantation
- •No concurrent growth factors
- •No concurrent monoclonal antibodies
- •No other concurrent immunotherapy
- •No other concurrent cytokines
- •No other concurrent biologic agents
- •Chemotherapy
- •See Disease Characteristics
- •No prior intensive myeloablative chemotherapy
- •No concurrent chemotherapy
- •Endocrine therapy
- 另有 13 项未显示
排除标准
- 未提供
研究者
研究点 (2)
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