NCT00019110已完成1 期
VACCINE THERAPY AND DETECTION OF IMMUNOLOGIC RESPONSES WITH HUMAN PAPILLOMAVIRUS 16 E6 AND E7 PEPTIDES IN PATIENTS WITH METASTATIC OR LOCALLY ADVANCED CERVICAL CANCER
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 6
研究概览
简要总结
RATIONALE: Vaccines made from certain human papillomaviruses may be able to help the body to kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of human papillomavirus vaccine therapy in treating patients who have advanced or recurrent cancer of the cervix, vagina, penis, anus, esophagus, or head and neck.
详细描述
OBJECTIVES:
- Determine whether endogenous cellular immunity to the viral oncoproteins human papilloma virus 16 (HPV16) E6 and E7 is present in patients with advanced or recurrent carcinoma of the cervix or other carcinomas that carry HPV16.
- Determine whether vaccination with antigen-presenting cells pulsed with synthetic peptide corresponding to the tumor's HPV16 E6 or E7 peptide can induce or boost patient cellular immunity to that particular peptide.
- Determine the type and characteristics of the cellular immunity generated in patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
- Determine the tumor response in patients treated with this regimen.
- Determine whether in vivo T cells generated specifically against HPV16 E6 or E7 peptide can be cloned and expanded in vitro against the corresponding peptide.
OUTLINE: Patients are stratified according to disease category as defined by the following:
- Stratum A: Stage III cervical cancer not previously treated with appropriate radiotherapy; stage IV or recurrent cervical cancer; or other advanced tumors that harbor human papilloma virus 16 (HPV16) such as anogenital, esophageal, or head and neck cancers.
- Stratum B: Stage III cervical cancer previously treated with standard therapy with no evidence of residual disease. Vaccination in this group is given as adjuvant therapy.
Patients are assigned to receive HPV E6 or E7 peptide by the principal investigator. Peripheral blood mononuclear cells (PBMC) (antigen presenting cells) are harvested and treated in vitro with sargramostim (GM-CSF) and pulsed with HPV16 E6 or E7. Patients receive vaccination with HPV16 E6 or E7 pulsed PBMC IV over 1-2 minutes during weeks 1, 3, 7, and 11 for a total of 4 vaccinations. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) continue treatment for a maximum of 1 year past CR.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically proven stage III, IV, or recurrent carcinoma of the cervix or other tumor that carries human papilloma virus 16 (HPV16) such as other anogenital (vulvar, penile, and anal), esophageal, and head and neck cancers
- •HLA-A2.1 positive
- •Patients with tumors other than cervical cancer must have no other therapeutic options
- •Fresh tissue or paraffin block available for HPV genome detection and typing (optional for cervical cancer)
- •No history of CNS metastases
- •PATIENT CHARACTERISTICS:
- •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
- •SGPT no greater than 4 times normal
- •Creatinine no greater than 2.0 mg/dL
- •Cardiovascular:
- •No myocardial infarction within the past 6 months
- •No New York Heart Association class III or IV heart disease
- •Immunologic:
- •No autoimmune disease, e.g.:
- •Systemic lupus erythematosus
- •Multiple sclerosis
- •Ankylosing spondylitis
- •HIV negative
- •Responsive to 1 of the following skin test antigens:
- •Mumps Trichophyton
- •Candida Tetanus
- •No active infection requiring antibiotics
- •No weight loss greater than 20% within the past 6 months
- •No other active malignancy except basal cell skin cancer
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •At least 4 weeks since prior immunotherapy and recovered
- •Chemotherapy:
- •At least 4 weeks since prior chemotherapy and recovered
- •Endocrine therapy:
- •At least 4 weeks since prior steroids and recovered
- •Radiotherapy:
- •At least 4 weeks since prior radiotherapy and recovered
- •Not specified
- •Recovered from the toxic effects of prior therapy
排除标准
- 未提供
研究者
研究点 (6)
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