NCT00019331已完成2 期
Vaccine Therapy With Tumor Specific Mutated Ras Peptides and IL-2 or GM-CSF for Adult Patients With Solid Tumors
适应症
相关药物
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 to kill tumor cells. Combining vaccine therapy with interleukin-2 and/or sargramostim may be a more effective treatment for solid tumors.
PURPOSE: Phase II trial to study the effectiveness of vaccine therapy plus interleukin-2 and/or sargramostim in treating adults who have metastatic solid tumors.
详细描述
OBJECTIVES:
- Determine whether endogenous cellular immunity to a tumor-specific mutated ras protein is present in cancer patients.
- Determine whether vaccination with synthetic peptides corresponding to the tumor's ras mutation with DetoxPC adjuvant, interleukin-2 (IL-2), and/or sargramostim (GM-CSF) can induce or boost a patient's cellular immunity to that particular mutation.
- Determine the type and characteristics of the cellular immune response generated.
- Determine the tolerance to and toxicity spectrum of such peptides given with DetoxPC adjuvant along with IL-2 and/or GM-CSF.
- Correlate immune response with tumor response in patients treated with these regimens.
OUTLINE: Patients are assigned to one of three treatment groups.
- Group I (closed to accrual 6/4/01): Patients receive tumor-specific ras peptide vaccine with DetoxPC subcutaneously (SC) once every 5 weeks for 3 courses. Beginning 4 days after vaccination, patients receive interleukin-2 (IL-2) SC 5 days a week for 2 weeks.
- Group II (closed to accrual 6/4/01): Patients receive sargramostim (GM-CSF) SC daily beginning 1 day prior to the vaccination and continuing for 4 days. Patients receive the vaccination as in group I immediately followed by GM-CSF on day 2. Patients are vaccinated once every 4 weeks for 3 courses.
- Group III: Patients receive the vaccination and IL-2 as in group I and GM-CSF as in group II.
In all groups, patients receive up to 15 vaccinations in the absence of disease progression.
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 solid tumors potentially expressing mutant ras, including colon, lung, pancreas, thyroid, endometrial, head and neck, testicular, hepatocellular, and melanoma
- •Ras mutations must be one of the following point mutations at codon 12:
- •Glycine to cysteine
- •Glycine to aspartic acid
- •Glycine to valine
- •Metastatic disease for which no known chemotherapy or radiotherapy would increase survival
- •Tumor tissue must be available for determination of ras mutation
- •No prior CNS metastases
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •More than 3 months
- •Hematopoietic:
- •WBC at least 2,000/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 2.0 mg/dL
- •SGOT/SGPT no greater than 4 times normal
- •No hepatitis B or C infection
- •Creatinine no greater than 2.0 mg/dL
- •Cardiovascular:
- •No active ischemic heart disease (New York Heart Association class III or IV)
- •No myocardial infarction within the past 6 months
- •No history of congestive heart failure, ventricular arrhythmias, or other arrhythmias requiring therapy
- •Immunologic:
- •No prior allergy to eggs
- •No prior autoimmune disease, including the following:
- •Autoimmune neutropenia, thrombocytopenia, or hemolytic anemia
- •Systemic lupus erythematosus, Sjogren's syndrome, or scleroderma
- •Myasthenia gravis
- •Goodpasture syndrome
- •Addison's disease, Hashimoto's thyroiditis, or active Graves' disease
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •HIV negative
- •No other active malignancy except curatively treated carcinoma in situ of the cervix or basal cell skin cancer
- •No active infection requiring antibiotics
- •No medical condition that would preclude study
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •At least 4 weeks since prior immunotherapy and recovered
- •Chemotherapy:
- •See Disease Characteristics
- •At least 4 weeks since prior chemotherapy and recovered
- •Endocrine therapy:
- •At least 4 weeks since prior steroids and recovered
- •Radiotherapy:
- •See Disease Characteristics
- 另有 2 项未显示
排除标准
- 未提供
研究者
研究点 (2)
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