NCT00021164已完成2 期
Immunization of HLA-A*0201 Patients With Metastatic Cancer Using a Peptide Epitope From the Telomerase Antigen
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Vaccines made from a peptide may make the body build an immune response and kill tumor cells.
PURPOSE: Randomized phase II trial to study the effectiveness of vaccine therapy in treating patients who have metastatic cancer.
详细描述
OBJECTIVES:
- Determine whether an immunologic response can be obtained in HLA*0201-expressing patients with metastatic cancer treated with telomerase: 540-548 peptide vaccine emulsified in Montanide ISA-51.
- Determine which vaccine strategy (frequency, schedule, and dosing) is best for future studies in these patients.
- Determine the toxicity of this treatment in these patients.
- Determine whether prior immunization with telomerase: 540-548 peptide vaccine results in increased clinical response to interleukin-2 in patients with melanoma.
OUTLINE: This is a randomized study. Patients are stratified according to disease (metastatic cutaneous melanoma vs other tumor types). Patients are randomized to one of three treatment arms.
- Arm I: Patients receive telomerase: 540-548 peptide vaccine emulsified in Montanide ISA-51 subcutaneously (SC) on day 1 of weeks 1-4 and 7-10. Patients also undergo leukapheresis over 3 hours at baseline and after each course of treatment.
- Arm II: Patients receive telomerase: 540-548 peptide vaccine emulsified in Montanide ISA-51 SC on day 1 of weeks 1, 4, 7, and 10. Patients also undergo leukapheresis over 3 hours at baseline, after the vaccine on week 4, and after each course of treatment.
- Arm III: Patients receive telomerase: 540-548 peptide vaccine emulsified in Montanide ISA-51 SC on days 1-4 of weeks 1, 4, 7, and 10. Patients undergo leukapheresis as in arm II.
Treatment in all arms repeats every 13 weeks for 4-6 courses in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 1 additional course of treatment after achieving CR.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Presenting with evaluable metastatic cancer
- •Refractory to standard treatment OR
- •Post-radiation for malignant glioma
- •HLA-A*0201 expression
- •PATIENT CHARACTERISTICS:
- •16 and over
- •Performance status:
- •Life expectancy:
- •More than 3 months
- •Hematopoietic:
- •WBC at least 3,000/mm^3
- •Platelet count at least 90,000/mm^3
- •Bilirubin no greater than 1.6 mg/dL
- •AST/ALT less than 3 times normal
- •Hepatitis B surface antigen negative
- •Creatinine no greater than 2.0 mg/dL
- •Cardiovascular:
- •No cardiac ischemia by stress thallium or comparable test*
- •No prior myocardial infarction*
- •No cardiac arrhythmias* NOTE: *Patients receiving interleukin-2 (IL-2) only
- •No obstructive or restrictive pulmonary disease (patients receiving IL-2 only)
- •Immunologic:
- •HIV negative
- •No autoimmune disease or any other known immunodeficiency disease
- •No active primary or secondary immunodeficiency
- •No other active major medical illness*
- •No active systemic infection
- •Not pregnant
- •Negative pregnancy test
- •Fertile patients must use effective contraception NOTE: *Patients receiving IL-2 only
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No prior telomerase: 540-548 peptide immunization
- •Chemotherapy:
- •Recovered from prior chemotherapy
- •Endocrine therapy:
- •No requirement for systemic steroid therapy
- •Radiotherapy:
- •See Disease Characteristics
- •Recovered from prior radiotherapy
- •Not specified
- •At least 3 weeks since prior systemic therapy for cancer
排除标准
- 未提供
研究者
研究点 (2)
Loading locations...
相似试验
已完成
2 期
Vaccine Therapy in Treating Patients With Refractory Metastatic MelanomaMelanoma (Skin)NCT00020397National Cancer Institute (NCI)
已完成
2 期
Immunization of HLA-A201 Patients With Metastatic Melanoma Using a Combination of Immunodominant Peptides From Three Melanoma Antigens, MART-1, GP100 and TyrosinaseNeoplasm MetastasisMelanomaNCT00001685National Cancer Institute (NCI)114
已完成
2 期
Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Metastatic Melanoma That Has Not Responded to Previous TreatmentMelanoma (Skin)NCT00022438National Cancer Institute (NCI)
终止
早期 1 期
Vaccine Therapy in Treating Patients With Stage IIB, Stage III, or Stage IV Colorectal CancerColorectal CancerNCT00091286Craig L Slingluff, Jr11
已完成
2 期
Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed By SurgeryIntraocular MelanomaMelanoma (Skin)NCT00089206University of Virginia7