NCT01846143已完成1 期
Evaluation of the Safety and Immunogenicity of a Multi-phosphopeptide Vaccine Plus PolyICLC in Participants With High Risk and Advanced Malignancies (Mel59)
Craig L Slingluff, Jr2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2013年5月最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Safety
研究概览
简要总结
The purpose of this study is to learn what effects (good and bad) experimental phosphopeptide vaccines plus a tetanus peptide and other substances called polyICLC and Montanide ISA-51 have on people with melanoma. The investigators will also look at whether the experimental reagents cause any changes in the immune system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Histologically or cytologically proven high-risk or advanced solid malignancies including melanoma, colorectal cancer, ovarian cancer, breast cancer, or non small-cell lung cancer (NSCLC) that meets one of the following criteria:
- •For Arms A and B: Stage IIIB-IV melanoma rendered clinically free of disease by surgery, other therapy, or spontaneous remission For Arm C: Stage IIA-IV melanoma rendered clinically free of disease by surgery, other therapy, or spontaneous remission For all Arms: Stage III or IV melanoma with disease, for patients who have failed other approved therapies, are not candidates for approved therapies, or refuse other approved therapies.
- •Staging will be based on the 7th edition AJCC staging system for melanoma and other cancers. Staging of mucosal melanomas will be based on the following system modified from the cutaneous melanoma staging system: IIA: 2.01- 4mm primary, or stage IIB: > 4mm primary, lymph node metastases = stage III, distant metastases = stage IV.
- •Breast cancer:
- •Metastatic stage IV or unresectable breast cancer on endocrine therapy or on no other systemic therapy who have had at least one prior therapy for their metastatic disease. Patients who are metastatic, but with no measurable disease are eligible. Participation in this study should not preclude the delivery of any approved and appropriate anti-cancer therapies, but they are not to be delivered concurrent with this trial, except that patients may participate while taking endocrine-only therapy (eg: aromatase inhibitors or tamoxifen or Lupron). Patients may also participate during pre-planned chemotherapy holidays.
- •Patients after resection for stage IIIA to IV breast cancer (any ER, PR, or Her2 status) after surgery, radiation therapy, adjuvant chemotherapy, or HER2 targeted therapy.
- •For Arm C only: Stage I-II, high risk patients with either triple negative breast cancer or HER2 positive disease are also eligible if the tumor is larger than 1 cm. Vaccine will be offered after surgery, radiation therapy or adjuvant chemotherapy (if indicated)
- •Colorectal cancer:
- •Metastatic (advanced) colorectal cancer that has failed at least 2 prior chemotherapy regimens, including 5-FU, ironotecan, and oxaliplatin.
- •High-risk resected metastatic colorectal cancer after resection of liver metastases and after approved agents are administered. For patients after surgical resection of liver metastases,
- •Eligibility to Arms A and B will be limited to those with at least 3 of the following risk factors: node-positive primary, disease-free interval less than 1 year, more than 1 liver metastasis, size of largest liver metastasis greater than 5 cm, and serum CEA greater than 200 ng/ml.
- •Eligibility to Arm C will be limited to those with at least 1 of the 5 risk factors listed above.
- •Ovarian cancer:
- •Ovarian or fallopian tube cancer that is recurrent or treatment refractory with no remaining alternative, approved therapy options with a reasonable possibility of clinical response.
- •Non small-cell lung cancer:
- •Patients with stage IIIB-IV non-small cell lung cancer who have stable disease or clinical response (CR/PR) after treatment with chemotherapy and concurrent radiation therapy.
- •Patients may have had prior therapy for this cancer in the adjuvant setting and may have had 1-4 prior systemic therapies for advanced cancer.
- •Patients may have had multiple primary melanomas.
- •Patients with less than or equal to 5 brain metastases may be eligible as long as the following 3 criteria are true:
- •The brain metastases have been completely removed by surgery or have been treated completely by stereotactic radiotherapy. Stereotactic radiotherapy, such as gamma knife, can be used up to 1 week prior to study entry.
- •There has been no evident growth of any brain metastasis since treatment.
- •No metastasis greater than 2 cm at the time of protocol entry
- •Patients with greater than 5 brain metastases may be eligible if the above 3 criteria are met and if at least one year has elapsed since the last treatment.
- •All participants must have:
- •ECOG performance status of 0 or 1 (Appendix 3) Ability and willingness to give informed consent
- •Patients must have at least one intact axillary and/or inguinal lymph node basin. A patient with a prior lymph node biopsy may be a candidate if lymphoscintigraphy demonstrates intact drainage to a node in that basin. A lymphoscintigram may be performed during screening to ensure that there is drainage to a regional node from a planned vaccine site. If the lymphoscintigram is performed and a sentinel lymph node is not located, the patient will be ineligible for this study if no other vaccine sites are available.
- •Laboratory parameters as follows: The following laboratory parameters will be required for all participants. If a lab value appears to be an error or a result of a transient or treatable condition, the investigator will use his/her clinical judgment to decide if the test may be repeated. The requirements for inclusion are as follows:
- •ANC > 1000/mm3
- •Total lymphocyte count > 500/mm
- •If this value is low on initial test after prior cytotoxic therapy, the test may be repeated as the patient recovers further from that therapy.
- •Platelets > 100,000/mm3
- •Hgb ≥ 9 g/dL
- •HGBA1C < 7%
- •AST and ALT ≤ 2.5 x upper limits of normal (ULN) Bilirubin ≤ 2.5 x ULN Alkaline phosphatase ≤ 2.5 x ULN
- •Renal Creatinine ≤ 1.5 x ULN
- •Serology (within 6 months of study entry) HIV negative Hepatitis C negative
- •LDH up to 2 x ULN
- •Participants must be 18 years or older at study entry.
- •Patients who have recurred or progressed either after or during administration of a cancer vaccine may be eligible to enroll 12 weeks following their last vaccination.
- •Exclusion Criteria
- •Patients who have had brain metastases unless they meet the criteria outlined in the inclusion criteria section of the protocol.
- •Patients who are currently receiving systemic cytotoxic chemotherapy, radiation, or other experimental therapy, or who have received this therapy within the preceding 4 weeks. Gamma knife or stereotactic radiosurgery may be administered within the prior 4 weeks, but must not be administered less than one week prior to study enrollment. Patients who are currently receiving nitrosoureas or who have received this therapy within the preceding 6 weeks.
- •Patients will not be eligible if there is clinically detectable malignancy deemed likely by the investigator to require intervention during the first 12 weeks of the study that would require premature discontinuation. Examples for such circumstances may include untreated bone metastases at risk for fracture, and rapidly progressive low volume disease.
- •Patients with known or suspected allergies to any component of the vaccine.
- •Patients receiving the following medications at study entry or within the preceding 4 weeks are excluded:
- •Agents with putative immunomodulating activity (with the exception of non-steroidal anti-inflammatory agents and topical steroids (see section 4.2.5(3)).
- •Allergy desensitization injections.
- •Systemic corticosteroids, administered parenterally or orally inhaled steroids (e.g. Advair®, Flovent®, Azmacort®) are not permitted. Topical corticosteroids are acceptable, including steroids with very low solubility administered nasally for local effects only (e.g. Nasonex®).
- •Any pharmacologic growth factors (e.g. GM-CSF, G-CSF, erythropoietin).
- •Interferon therapy
- 另有 11 项未显示
排除标准
- 未提供
结局指标
主要结局
Safety
时间窗: 30 days post administration of the last vaccine
Adverse events occurring in each subject will be reported until 30 days post administration of the last vaccine.
次要结局
- Immunogenicity of phosphopeptide vaccines(Through Day 85)
研究者
Craig L Slingluff, Jr
Director, Human Immune Therapy Center
University of Virginia
研究点 (2)
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