NCT00019591已完成1 期
A Phase I/II Trial of Vaccination With Mutant Ras Peptide-Pulsed Dendritic Cells in the Treatment of HLA A2.1 Positive Patients With Colorectal Cancer
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 2
- 主要终点
- Response rate every 3 months for up to a year after completion of study treatment
研究概览
简要总结
RATIONALE: Vaccines may make the body build an immune response that will kill cancer cells. Combining vaccine therapy with interleukin-2 may kill more cancer cells.
PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy with or without interleukin-2 in treating patients who have locally advanced or metastatic colorectal cancer.
详细描述
OBJECTIVES:
- Determine the frequency of immunologic response in patients with locally advanced or metastatic colorectal cancer treated with ras peptide-pulsed dendritic cell vaccine with or without interleukin-2.
- Determine the tumor response and survival time in patients with metastatic colorectal cancer treated with vaccine plus interleukin-2.
- Determine the time to progression in patients with locally advanced colorectal cancer treated with adjuvant vaccine.
OUTLINE: Patients are assigned to 1 of 2 treatment groups according to extent of disease. Patients with prior locally advanced disease are assigned to treatment group A, while those with metastatic disease are assigned to treatment group B.
- Group A: Patients are vaccinated against influenza on day -6. Patients undergo collection of peripheral blood mononuclear cells (PBMC) on day -4. The PBMC are cultured with sargramostim (GM-CSF) and interleukin-4 for 5 days and CD40 ligand for 24 hours and then pulsed for 2 hours with the appropriate peptide to form a vaccine. Patients receive ras peptide-pulsed dendritic cell vaccine IV over 5 minutes on days 1, 15, 29, 43, and 57.
- Group B: Patients undergo collection of PBMC and receive vaccination as in group A. Patients also receive interleukin-2 subcutaneously on days 2-6 and 9-13.
Treatment in both groups repeats every 2 weeks for up to 5 vaccinations in the absence of disease progression or unacceptable toxicity.
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 locally advanced or metastatic colorectal cancer
- •Metastatic disease must be radiologically proven
- •HLA-A2-1 positive
- •Locally advanced disease must have had prior resection or incomplete resection with poor prognosis
- •Locally advanced disease includes:
- •Stage III or IV colon cancer (T4 or any T, N2-3, M0)
- •Stage III or IV rectal cancer (T4 or T3, N1-3)
- •Resectable or unresectable T4 disease after radiotherapy, chemotherapy, and/or surgery
- •Absence of measurable disease but more than a 50% chance of recurrence
- •Completely resected or locally advanced disease may have had conventional therapy completed within 1-12 months (surgery alone, with or without adjuvant chemotherapy and/or radiotherapy) prior to study entry
- •Metastatic disease patients must have bidimensionally measurable disease
- •Bone lesions with well-demarcated borders allowed
- •Lesions seen only on bone scan, pleural effusions, ascites, and changes in carcinoembryonic antigen are not considered measurable disease
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Lymphocyte count at least 470/mm^3
- •Granulocyte count at least 1,000/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 2.0 mg/dL*
- •SGOT no greater than 4 times upper limit of normal (ULN) (2.5 times ULN for adjuvant patients)*
- •Albumin at least 3 g/dL
- •No active viral hepatitis
- •No evidence of chronic infection due to hepatitis C
- •Hepatitis B surface antigen negative NOTE: *Unless due to metastatic disease
- •Creatinine no greater than 2.0 mg/dL
- •Cardiovascular:
- •No history of cardiac failure, significant arrhythmias, or coronary artery disease (metastatic disease patients only)
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •HIV negative
- •No prior malignancy with a 50% chance of recurrence within 5 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix
- •No medical or psychiatric condition that would preclude compliance
- •No serious medical condition that would preclude apheresis
- •No serious infection
- •No uncontrolled thyroid disease (metastatic disease patients only)
- •Patients with an allergy to eggs are allowed but are not vaccinated against influenza during study
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No prior immunologic therapy directed at the cellular immune system
- •Chemotherapy:
- •See Disease Characteristics
- •Prior chemotherapy for metastatic disease allowed
- •At least 4 weeks since prior chemotherapy
- •No concurrent chemotherapy or anticipated need for chemotherapy for 2 months after vaccinations
- •Endocrine therapy:
- •At least 4 weeks since prior supraphysiologic steroid therapy
- 另有 6 项未显示
排除标准
- 未提供
结局指标
主要结局
Response rate every 3 months for up to a year after completion of study treatment
次要结局
未报告次要终点
研究者
研究点 (2)
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