NCT00003568已完成2 期
A Randomized Phase II Trial of a Mutated gp100 Melanoma Peptide (g209-217(210M) With Hight Dose Interleukin-2 (IL-2) in HLA-A2.1+Patients With Metastatic Melanoma
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 18
研究概览
简要总结
RATIONALE: Vaccines may make the body build an immune response that will kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells.
PURPOSE: Randomized phase II trial to study the effectiveness of vaccine therapy with interleukin-2 in treating patients with metastatic melanoma.
详细描述
OBJECTIVES:
- Define the antitumor activity of gp100:209-217 (210M), a melanoma peptide derived from gp100 mixed with Montanide ISA-51, in combination with high-dose interleukin-2 (IL-2) administered by various schedules in patients with advanced melanoma.
- Examine the effect of the addition of gp100:209-217 (210M) peptide vaccine to high-dose IL-2 on the toxicity of the treatment in these patients.
- Define the induction of T-cell responses to gp100:209-217 (210M) peptide and its gp100 (parent) protein by ELISA with interferon gamma production or CTL precursor frequencies in these patients after the initial course of treatment.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior therapy (adjuvant interferon vs chemotherapy for advanced disease vs both vs none), ECOG performance status (0 vs 1), and number of organ sites involved (1 vs more than 1). Patients are randomized into 1 of 3 treatment arms. (Arm III closed to accrual as of 11/30/1998.)
- Arm I: Patients receive vaccination comprising gp100:209-217 (210M) peptide mixed with Montanide ISA-51 subcutaneously on days 1, 22, 43, and 64. Patients also receive high-dose interleukin-2 (IL-2) IV over 15 minutes every 8 hours on days 2-6 and 16-20.
- Arm II: Patients receive vaccination as in arm I on days 1, 22, 43, and 64. Patients also receive high-dose IL-2 as in arm I on days 44-48 and 60-64. Patients who demonstrate rapid visible disease progression during the initial 4 weeks of therapy while maintaining good performance status may begin high-dose IL-2 on day 23.
- Arm III (closed to accrual as of 11/30/1998): Patients receive vaccination as in arm I on day 1 and then high-dose IL-2 as in arm I on day 2. Patients with nonhematologic toxicity may only receive vaccination on weeks 4, 7, and 10. Other patients may also receive IL-2 beginning on day 2 of each treatment week (4, 7, and 10) for up to 14 doses.
Patients in each arm may receive up to a total of 3 courses of treatment.
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:
- •Histologically confirmed clearly progressive metastatic or unresectable melanoma
- •Must be HLA-A2.1 positive
- •Measurable disease
- •No active brain metastases, leptomeningeal disease, or seizure disorder
- •More than 4 months since prior definitive therapy (surgery or radiotherapy) for brain metastases and must not have evidence of disease on brain CT scan or MRI
- •No ascites or pleural effusions
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •ECOG 0-1 OR
- •Karnofsky 80-100%
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •WBC at least 3,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Hemoglobin at least 9 g/dL
- •Bilirubin no greater than 2.0 mg/dL
- •Creatinine no greater than 1.5 mg/dL OR
- •Creatinine clearance at least 60 mL/min
- •Cardiovascular:
- •No congestive heart failure
- •No symptoms of coronary artery disease
- •No serious cardiac arrhythmias
- •No evidence of prior myocardial infarction on EKG
- •Normal cardiac stress test required for all patients over 40 years
- •FEV_1 greater than 2.0 liters or at least 75% of predicted
- •No chronic obstructive pulmonary disease
- •HIV negative
- •No significant systemic infection
- •No contraindication to use of pressor agents
- •No history of major psychiatric illness
- •No other major illness that would significantly increase the risk of immunotherapy
- •No other active malignancy except surgically cured nonmelanoma skin cancer or carcinoma in situ or stage I carcinoma of the cervix
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No prior interleukin-2
- •At least 4 weeks since prior vaccine therapy or other cytokine therapy
- •Chemotherapy:
- •One prior chemotherapy regimen allowed
- •At least 4 weeks since prior chemotherapy (6 weeks for carmustine or lomustine) and recovered
- •Endocrine therapy:
- •No concurrent steroids
- •Radiotherapy:
- •See Disease Characteristics
- •No prior radiotherapy to areas of measurable disease unless there has been clearly progressive disease in this site or there is measurable disease outside of areas of prior radiation
- 另有 5 项未显示
排除标准
- 未提供
研究者
研究点 (18)
Loading locations...
相似试验
已完成
2 期
Vaccine Therapy in Treating Patients With Metastatic Melanoma of the EyeExtraocular Extension MelanomaRecurrent Intraocular MelanomaNCT00020475National Cancer Institute (NCI)
Unknown
2 期
Vaccine Therapy and Chemotherapy With or Without Tetanus Toxoid Compared With Chemotherapy Alone in Treating Patients With Metastatic Colorectal CancerColorectal CancerNCT00027833Herbert Irving Comprehensive Cancer Center
终止
1 期
Vaccine Therapy in Patients With Stages IIIB/IV Non-Small Cell Lung Cancer Who Have Finished First-Line ChemotherapyLung CancerNCT00534209University of Miami1
已完成
1 期
Vaccine Therapy in Treating Patients With Resected or Locally Advanced Unresectable Pancreatic CancerPancreatic CancerNCT00008099University of Pittsburgh25
Unknown
2 期
Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed With SurgeryMelanoma (Skin)NCT00086866European Organisation for Research and Treatment of Cancer - EORTC165