An Exploratory Study of Adjuvant Therapy of Pegylated Interferon-Alfa 2b Plus Melanoma Peptide Vaccine in Patients With Resected Stage II and III (N1a, N2a) Melanoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Patient Maximum T-cell Levels During 24-Week Treatment
研究概览
简要总结
The goal of this clinical research study is to find the best dosing schedule of a combined treatment of PEG Intron® (pegylated Interferon-alfa 2b) plus a peptide vaccine (gp100) that may help improve immune response in patients that had Stage II or Stage III melanoma and are free of the disease. The safety and tolerability of this drug combination will also be studied. Researchers also want to collect long-term follow-up information.
详细描述
The Study Drugs:
Pegylated Interferon alfa-2b is a protein made by the human immune system that helps to fight viral infections and regulate cell function.
Gp100 is a protein that is found on melanoma cells. In laboratory studies, the gp100 vaccine has been shown to stimulate the immune system to "recognize" and kill melanoma cells that have gp100 on their cell surfaces.
Evaluation of Immune cell response to vaccine:
Blood (about 3-1/2 tablespoons) will be drawn on Weeks 4, 7,10,13,16,19, and 22 for tests to check the response of your immune system to the vaccine, before each injection. These tests are for research purposes only and will not be used to make decisions about your medical care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients must be free of disease after surgical resection for American Joint Committee on Cancer (AJCC) stage II or III (N1a) melanoma (T2b, T3a, T3b, T4a, T4b and N1a or N2a). Diagnosis must be confirmed by the Pathology Department of MD Anderson Cancer Center.
- •Patients must be HLA-A0201 positive.
- •Patients must be fully recovered from surgery, for at least one month, but not more than 90 days after surgery and before study entry.
- •Patients must have no other malignancies. Patients with prior history of any in situ cancer, lobular carcinoma of the breast in situ, cervical cancer in situ, atypical melanocytic hyperplasia or Clark I melanoma in situ or basal or squamous skin cancer are eligible. Patients with other malignancies are eligible, if they have been continuously disease-free for 5 years prior to the time of study entry.
- •Patients must be >/= 18 years of age.
- •Patients must give signed written informed consent.
- •Women of childbearing potential (WOCBP) must not be pregnant (negative urine human chorionic gonadotropin (HCG) within 2 weeks of treatment) or lactating. A WOCBP has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months (i.e., who has had menses at any time in the preceding 24 consecutive months).
- •Women of childbearing potential and sexually active males must be counseled to use an accepted and effective method of contraception (including abstinence) while on treatment and for a period of 3 months after completing or discontinuing treatment. Simultaneous use of two contraceptive methods such as, intrauterine device (IUD) or condom and contraceptive jelly is considered the accepted method of contraception.
- •Patients must have Eastern Cooperative Oncology Group (ECOG) performance status 0 or
- •Patients must have white blood cell count (WBC) >/= 3,000/mm3, platelet count >/= 100,000/mm3, and hemoglobin >/= 9 g/dL or 5.6 mmole/L obtained within 2 weeks of study entry.
- •Patients must have AST, ALT, LDH, alkaline phosphatase, and bilirubin within institutional upper limit (IUL) of normal and serum creatinine < 2.0 mg/dl or < 140 micromol/L all obtained within 2 weeks of study entry. Patients with Gilbert's Disease may have bilirubin </= to 2 x (ULN).
- •Patients must have a CT of chest, abdomen, pelvis, and a MRI or CT scan of the brain performed within 4 weeks of study entry.
排除标准
- •Patients with clinical, radiological/laboratory or pathological evidence of incompletely resected melanoma or any distant metastatic disease.
- •Patients with autoimmune disorders or receiving immunosuppressive therapy including chemotherapy, steroids or methotrexate.
- •Patients requiring consistent use of antihistamines or non-steroidal anti-inflammatory drugs.
- •Patients with a history of active ischemic heart disease or cerebro-vascular disease, congestive heart failure (NYHA class >2) or anginal syndrome requiring ongoing medical treatment.
- •Patients have a diagnosis or evidence of organic brain syndrome or significant impairment of basal cognitive function or any psychiatric disorder that might preclude participation in the protocol. Any questionable patients will be reviewed by the investigator or attending physician.
- •Patients having prior radiotherapy, chemotherapy or any immunotherapy including, tumor vaccines, interferon, interleukins, levamisole or other biologic response modifiers for any type of cancer.
- •Patients with a history of central nervous system (CNS) demyelinating, inflammatory disease or hereditary or acquired grade 2 or higher peripheral neuropathy.
- •Patients with any other significant medical or surgical condition or psychiatric disorder, which includes any serious psychiatric illness that has not been adequately controlled despite intervention (with our without medication) with known history of HIV or hepatitis infection may interfere with the completion of this trial or with the evaluation of safety and efficacy of the study compound.
- •Patients with thyroid dysfunction not responsive to therapy.
- •Patients with pre-existing psychiatric condition including, but not limited to: a. History of severe depression, including the following: 1) Hospitalization for depression 2) Electroconvulsive therapy for depression 3) Depression that resulted in a prolonged absence from work and/or significant disruption of daily functions. b. Suicidal or homicidal ideation and/or suicidal or homicidal attempt. c. History of severe psychiatric disorders (eg. psychosis, post-traumatic stress disorder or mania). d. Past history or current use of lithium and/or antipsychotic drugs.
研究组 & 干预措施
Group 1
Pegylated Interferon alfa-2b (Once week x 4 weeks) + GP-100 Peptide
干预措施: Pegylated Interferon-Alfa 2b (PEG Intron) (Drug)
Group 1
Pegylated Interferon alfa-2b (Once week x 4 weeks) + GP-100 Peptide
干预措施: GP-100 Peptide Vaccine (Drug)
Group 2
Pegylated Interferon alfa-2b (Once week x 8 weeks) + GP-100 Peptide
干预措施: Pegylated Interferon-Alfa 2b (PEG Intron) (Drug)
Group 2
Pegylated Interferon alfa-2b (Once week x 8 weeks) + GP-100 Peptide
干预措施: GP-100 Peptide Vaccine (Drug)
Group 3
Pegylated Interferon alfa-2b (Once week x 12 weeks) + GP-100 Peptide
干预措施: Pegylated Interferon-Alfa 2b (PEG Intron) (Drug)
Group 3
Pegylated Interferon alfa-2b (Once week x 12 weeks) + GP-100 Peptide
干预措施: GP-100 Peptide Vaccine (Drug)
结局指标
主要结局
Patient Maximum T-cell Levels During 24-Week Treatment
时间窗: Patient's T-cell levels assessed every 3 weeks using a tetramer assay.
次要结局
未报告次要终点