Activation of pDCs at the Tumor and Vaccine Site With a Toll Like Receptor (TLR) Agonist

M.D. Anderson Cancer Center1 个研究点分布在 1 个国家目标入组 47 人开始时间: 2010年5月20日最近更新: 2021年8月13日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: M.D. Anderson Cancer Center
入组人数: 47
试验地点: 1
主要终点: Comparison of Immune Responses of Vaccine+R848 to Vaccine Alone

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The goal of this clinical research study is to learn if the vaccines, gp100(g209-2M), and MAGE-3, when given in combination with resiquimod (R848), can help to stimulate the immune system against melanoma.

详细描述

The Study Drug/Vaccines:

Resiquimod (R848) is designed to increase the production of antigen-specific T-cells, to activate immune cells, and to increase T-cells going into the tumor, which may cause the tumor cells to die.

gp100(g209-2M) and MAGE-3 are vaccines designed to stimulate immune cells, also called T-cells, which may help the immune system to recognize and kill melanoma cells.

Study Groups:

If you are found to be eligible to take part in this study, and you have metastatic melanoma, you will be assigned to Group 3. If you have had the melanoma removed and want to be treated to try to keep it from coming back, you will be randomly assigned (as in the flip of a coin) to Group 1 or 2.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Factorial
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: 否

入选标准

•HLA-A*0201 positive (to enable immunization with the HLA class I restricted gp100(g209-2M) peptide). Stage IIB or IIC patients will be enrolled after review and approval by the PI. (a tool to determine the projected survival at 5 years, like, but not limited to, the nomogram at www.melanomaprognosis.org. If the projected survival is less than 50% at 5 years, then the patient is considered for enrollment. This is with the recognition that the adjuvant, if effective offers a significant impact in that group of stage II patients.)
•Patients >/= 18 years old with histologically documented metastatic melanoma with a. (Metastatic disease cohort) Measurable disease, stage IIIB, IIIC (in transit lesions with or without nodal metastases) that includes lesions accessible for biopsies or IV M1B b. (Adjuvant cohort) subjects who are NED and stage III or IV. This includes patients with stage IV disease resected to NED. Stage IIB or IIC patients will be enrolled after review and approval by the PI.
•Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
•At least 2 biopsiable easily accessible cutaneous and subcutaneous lesions in patients in the metastatic disease cohort
•White Blood Count (WBC) >/= 3000/mm^3 (part 1 & 2)
•Platelet count >/= 90,000/mm^3 (part 1 & 2)
•Serum alanine aminotransferase (ALT) and Aspartate Aminotransferase (AST) </= 3 X upper limit of normal (ULN) (part 1 & 2)
•Total bilirubin </= 2 X ULN, except for patients with Gilbert's syndrome who must have a total bilirubin less than 3.0 mg/dl Total bilirubin </= 2 X ULN, except for patients with Gilbert's syndrome who must have a total bilirubin less than 3.0 mg/dl (part 1 & 2)
•Seronegative for human immunodeficiency virus (HIV) antibody. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who are HIV seropositive can have decreased immune competence and thus may be less responsive to the experimental treatment and more susceptible to its toxicities.)
•Negative pregnancy test for women of childbearing potential (WOCBP) A WOCBP has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 12 consecutive months (i.e., who has had menses at any time in the preceding 12 consecutive months)
•Patients of both gender must practice a barrier method of birth control while participating in this trial.

排除标准

•Active autoimmune disease requiring active therapy with any form of steroid or immunosuppressive therapy or a documented history of any of the following: inflammatory bowel disease; regional enteritis; systemic lupus erythematosis; Sjogren's syndrome; inflammatory neurologic disorder such as multiple sclerosis; or any immune mediated disease that can cause life-threatening symptoms or severe organ/tissue damage in the opinion of the principle investigator.
•Concurrent systemic or inhaled steroid therapy
•Any form of active primary or secondary immunodeficiency
•Prior malignancy except for the following: adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer, thyroid cancer (except anaplastic) or any cancer from which the patient has been disease-free for 2 years
•History of immunization with gp100(g209-2M)
•Active systemic infections requiring intravenous antibiotics
•Women who are breastfeeding
•Prior systemic therapy, radiation therapy or intracavitary surgery (intra-thoracic, intra-abdominal or intracranial) within 28 days of starting study treatment.
•Patients on chronic anticoagulation such as Aspirin, Plavix, or Coumadin who cannot have anticoagulation held for procedures are not eligible due to the need for leukapheresis

研究组 & 干预措施

Group 1: gp100 and MAGE-3 + R848

Active Comparator

1 ml of gp100 peptide vaccine and 1 ml of MAGE-3 peptide vaccine daily for 8 weeks with R848 Gel applied to gp100 injection site immediately. Injections given intradermally and subcutaneously at 2 separate sites in separate extremities. Half of each dose given one way, and half given the other way. Vaccines given on the same day. Participant receives a total of 4 injections each week.