NCT00039000已完成3 期
A Phase III Study of Heat Shock Protein-Peptide Complex (HSPPC-96) Versus Physician's Choice Including Interleukin-2 and/or Dacarbazine/Temozolomide-based Therapy and/or Complete Tumor Resection in Stage IV Melanoma
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Agenus Inc.
- 入组人数
- 350
- 试验地点
- 77
研究概览
简要总结
The primary goal of this study is to determine if people with metastatic melanoma who receive Heat Shock Protein-Peptide Complex - 96 (HSPPC-96 or Oncophage) after surgery live longer than people who may or may not have surgery but who receive conventional chemotherapy including IL-2/DTIC. A second goal is to determine the safety and frequency of side effects in subjects who receive therapy with HSPPC-96.
详细描述
Primary Objective:
- To determine whether subjects with stage IV melanoma randomized to HSPPC-96 have longer survival than subjects randomized to physician's choice including interleukin-2 and/or dacarbazine/temozolomide and/or complete tumor resection.
Secondary Objective:
- To determine frequency of adverse events in subjects randomized to HSPPC-96.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Eligibility Assessment:
- •(The following assessments must be obtained within three weeks prior to randomization into the study)
- •Medical history and physical examination (including EGOG score, evidence of immunosuppression);
- •CT/MRI of the chest, abdomen and pelvis;
- •Clinical examination;
- •CT/MRI of the brain;
- •Complete Blood Count with differential including platelets;
- •Electrolytes (Na, Cl, K, HCO3, Ca, Mg, PO4);
- •Renal function tests (BUN and creatinine);
- •Liver function tests (bilirubin, AST, ALT);
- •Serum pregnancy test for all women of childbearing potential.
- •Inclusion Criteria:
- •Stage IV Melanoma (AJCC);
- •No prior therapy for stage IV melanoma;
- •No prior therapy with interleukin-2 and/or dacarbazine/temozolomide within the past 12 months prior to study entry;
- •Candidate for surgical resection of some/all sites of melanoma and expected to obtain greater tan or equal to 7 grams of viable cancer tissue (in aggregate), which is equivalent to a greater than or equal to 2 cm lesion on CT/MRI or clinical examination;
- •No brain metastases;
- •ECOG score 0 or 1;
- •Adequate cardiac function;
- •Adequate hematopoietic, liver and renal function;
- •Female subjects of child-bearing potential must agree to use contraception during the study
- •Signed written informed consent.
排除标准
- •Mucosal or ocular melanomas;
- •Other malignancies treated within the last five years, except in situ cervix carcinoma or non-melanoma skin cancer;
- •Primary or secondary immunodeficiency, in the opinion of the investigator (including immunosuppressive disease, or use of systemic corticosteroids or other immunosuppressive medications);
- •Prior splenectomy;
- •Uncontrolled infection or other serious medical illnesses;
- •Women who are pregnant or breast-feeding;
- •Subjects participating in any other studies requiring administration of an investigational drug/biologic agent.
研究者
研究点 (77)
Loading locations...
相似试验
Unknown
不适用
Study of Heat Shock Proteins as Prognostic Factor of Acute Renal Failure in Children (HSP-Study)Kidney Failure, AcuteNCT00230412University of Munich Children's Clinic120
已完成
1 期
GP96 Heat Shock Protein-Peptide Complex Vaccine in Treating Patients With Recurrent or Progressive GliomaBrain and Central Nervous System TumorsNCT00293423University of California, San Francisco96
终止
1 期
Trial of Heat Shock Protein Peptide Complex-96 (HSPPC-96) VaccineAstrocytoma, Grade IIIAnaplastic EpendymomaClear Cell EpendymomaEpendymomaGlioblastoma MultiformeNCT02722512Ann & Robert H Lurie Children's Hospital of Chicago10
已完成
1 期
Phase I/II Study of Chemo-Immunotherapy Combination in Melanoma PatientsMelanomaNCT00559026Istituto Superiore di Sanità10
招募中
3 期
Duration of Anti-PD-1 Therapy in Metastatic MelanomaUnresectable/Metastatic MelanomaNCT02821013Canadian Cancer Trials Group614