Phase I Study of TH1 Dendritic Cell Immunotherapy for the Treatment of Cutaneous Angiosarcoma
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 入组人数
- 24
- 主要终点
- Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
研究概览
简要总结
To find the highest tolerable dose of an mRNA vaccine that can be safely given to patients with cutaneous angiosarcoma
详细描述
Objectives:
Primary objective:
•To determine the safety, toxicity, and feasibility of delivering autologous dendritic cells (DCs) loaded with tumor lysate plus mRNA to patients with cutaneous head & neck angiosarcoma as adjuvant therapy.
Secondary objective:
• To assess the recurrence free survival and overall survival in treated patients in order to make initial assessment of activity of this therapeutic approach
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
- 否
入选标准
- •Patients with histologically confirmed cutaneous head & neck angiosarcoma deemed to be potentially resectable and who are deemed to be good candidates for postoperative therapy with radiation and study treatment.
- •Should be willing to undergo biopsy to provide fresh frozen tumor tissue for use in the creation of the vaccine.
- •18 years of age or older and able to provide informed consent.
- •Adequate kidney, liver, bone marrow function, and immune function, as follows:
- •Hemoglobin ≥ 8.0 gm/dL
- •Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
- •Lymphocytes ≥ 500 cells/mm3
- •Platelet count ≥ 75,000 /mm3
- •CD4+ T-cell counts ≥ 200/mm3
- •Glomerular filtration rate (GFR) > 60 mL/min/m2
- •For males = (140 - age[years]) x (body weight [kg]) (72) x (serum creatinine [mg/dL]
- •For females = 0.85 x male value
- •Total bilirubin ≤ 1.5 times upper limit of normal (ULN),
- •Aspartate transaminase AST (SGOT) and alanine aminotransferase ALT (SGPT) ≤ 2.5 times the ULN
- •TSH range between 0.4 - 4.0 mIU / L
- •aPTT or INR ≤ 1.5 × ULN unless subject is receiving anticoagulant therapy. If receiving anticoagulant therapy, patient is eligible as long as prothrombin time, international normalized ratio (INR), or activated partial thromboplastin time is within therapeutic range of intended use of anticoagulants
- •ECOG performance status ≤ 2.
排除标准
- •Locally advanced tumors deemed unresectable and/or metastatic tumors
- •Received live vaccines within 30 days prior to the first dose of trial treatment and while participating in the trial. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster, yellow fever, rabies, BCG, and typhoid vaccine.
- •Uncontrolled HIV infection with CD4+ <200 c ells/µl or active HBC or HCV disease that requires antiviral therapy.
- •Need for concurrent therapy with corticosteroids or any systemic immunosuppressive agents during the vaccination phase of the study.
- •History of systemic autoimmune disease
- •Female patients who are pregnant, breast feeding, or of childbearing potential without a negative pregnancy test prior to baseline. Male or female patients of childbearing potential unwilling to use contraceptive precautions (refer Table 1) throughout the trial and 3 months following discontinuation of study treatment. Post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Women of childbearing potential must have a negative serum pregnancy test prior to the first treatment.
- •Concurrent participation on another therapeutic clinical trial.
- •Patients unwilling or unable to comply with the protocol or provide informed consent.
研究组 & 干预措施
Dose Escalation/Deescalation
Participants will receive up to 3 doses of the vaccine (each vaccine is given 2 weeks apart). The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen
干预措施: PEGYLATED-INTERFERON ALPHA-2A (Drug)
Dose Escalation/Deescalation
Participants will receive up to 3 doses of the vaccine (each vaccine is given 2 weeks apart). The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen
干预措施: mRNA plus Lysate-loaded Dendritic Cell Vaccine (Biological)
Dose Escalation/Deescalation
Participants will receive up to 3 doses of the vaccine (each vaccine is given 2 weeks apart). The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen
干预措施: Paclitaxel (Drug)
Dose Escalation/Deescalation
Participants will receive up to 3 doses of the vaccine (each vaccine is given 2 weeks apart). The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen
干预措施: Filgrastim (Drug)
结局指标
主要结局
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
时间窗: through study completion; an average of 1 year
次要结局
未报告次要终点