NCT00091143已完成1 期
A Pilot Trial of Therapeutic Vaccination With a Modified gp100 Melanoma Peptide (gp100:209-217(210M)), Montanide ISA 51, and KLH With Reconstitution After Chemotherapy to Induce Lymphopenia in Patients With Metastatic Melanoma
Providence Cancer Center, Earle A. Chiles Research Institute2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2004年7月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Toxicity by clinical and laboratory observation at 1 month
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as fludarabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Vaccines made from peptides may make the body build an immune response to kill tumor cells. Infusions of a person's white blood cells may be able to replace immune cells that were destroyed by chemotherapy. Combining fludarabine with vaccine therapy and white blood cell infusions may kill more tumor cells.
PURPOSE: This randomized phase I trial is studying the side effects of giving vaccine therapy together with fludarabine and white blood cell infusions and to see how well it works in treating patients with unresectable or metastatic melanoma.
详细描述
OBJECTIVES:
Primary
- Determine the toxicity and immune effects of vaccination comprising modified gp100 peptide (gp100:209-217[210M]), Montanide ISA-51, and keyhole limpet hemocyanin followed by peripheral blood mononuclear cell reinfusion after treatment-induced lymphopenia with fludarabine in patients with unresectable or metastatic melanoma.
- Determine the induction of antigen-specific T-cell responses in patients treated with this regimen.
- Determine the kinetics and duration of immune response in patients treated with this regimen.
- Compare the immunologic effects of this regimen in these patients with historical results.
Secondary
- Compare 2 different dosing schedules of fludarabine, in terms of induction of lymphopenia and granulocytopenia and on the induction of a specific immune response to this vaccine, in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 or cytologically confirmed malignant melanoma
- •Metastatic or unresectable disease
- •Measurable disease
- •HLA-A2 positive
- •Received at least 1 prior immunotherapy and/or chemotherapy regimen for metastatic disease (first 6 patients only)
- •No known brain metastases unless previously treated with radiotherapy and/or surgery AND is stable for at least 1 month after treatment
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •ECOG 0-2 OR
- •Karnofsky 60-100%
- •Life expectancy
- •More than 3 months
- •Hematopoietic
- •WBC ≥ 3,000/mm^3
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Absolute lymphocyte count ≥ 500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Hemoglobin ≥ 10 g/dL (transfusions allowed)
- •Hematocrit ≥ 24%
- •No other active bleeding
- •Bilirubin < 2 times upper limit of normal (ULN) (unless due to Gilbert's disease)
- •AST and ALT < 3 times ULN
- •Hepatitis B surface antigen negative
- •Hepatitis C antibody negative
- •Creatinine < 2 mg/dL
- •No uncontrolled hypercalcemia
- •Cardiovascular
- •No uncontrolled symptomatic congestive heart failure
- •No unstable angina pectoris
- •No uncontrolled cardiac arrhythmia
- •No uncontrolled hypertension
- •No uncontrolled bronchospasm
- •No hemoptysis
- •Immunologic
- •Negative serology for all of the following:
- •HIV-1 and HIV-2
- •HTLV-1 and -2
- •Rheumatoid factor < 43 units/μL
- •Anti-nuclear antibody < 11 units/μL
- •No history of multiple sclerosis, systemic lupus erythematosus, or myasthenia gravis
- •No primary or secondary immunodeficiency
- •No active infection
- •No allergy to seafood or shellfish that would preclude study participation
- •No active gastrointestinal bleeding
- •No uncontrolled hyperglycemia
- •No other medical or psychiatric condition or social situation that would preclude study compliance
- •No other uncontrolled illness
- •Not pregnant or nursing
- 另有 20 项未显示
排除标准
- 未提供
结局指标
主要结局
Toxicity by clinical and laboratory observation at 1 month
Antigen-specific T-cell responses by tetramer analysis, ELISPOT, and cytokine flow cytometry periodically
次要结局
- Compare 2 different dosing schedules of fludarabine in terms of lymphocyte recovery using a complete blood count periodically
- Tumor regression by standard imaging at study completion
研究者
研究点 (2)
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