NCT01516307已完成2 期
A Double-blind, Randomized Trial of Active Immunotherapy With Globo H-KLH (OPT-822) in Subjects With Metastatic Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 349
- 试验地点
- 43
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
The purpose of this study is to compare active immunotherapy (OPT-822/OPT-821) with PBS in combination with low dose cyclophosphamide, in post-treated metastatic breast cancer subjects with stable disease or response to treatment.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female subjects ≥ 21 years of age with histological or cytological diagnosis of breast carcinoma.
- •Subjects with metastatic breast cancer who have achieved stable disease (SD), partial response (PR), or complete response (CR) after at least 1 regimen of anticancer therapy (i.e. chemotherapy or target therapy, either alone or in any combination). Involvement of supraclavicular lymph node is considered metastasis.
- •Subjects must have recovered from toxicities of prior therapies. (i.e. CTCAE ≤ grade 2).
- •Performance status: ECOG ≤ 1 and life expectancy ≥ 3 months.
- •Organ Function Requirements - Subjects must have adequate organ functions as defined below:
- •AST/ALT ≤ 3X ULN (upper limit of normal)
- •AST/ALT ≤ 5X ULN [with underlying Liver Metastasis]
- •Total Bilirubin ≤ 2.0 X ULN
- •Serum Creatinine ≤ 1.5X ULN
- •ANC ≥ 1500 /μL
- •Platelets > 100,000/μL
- •No Symptomatic Congestive Heart Failure (Ejection Fraction EF ≥ 50%)
- •Ability to understand and the willingness to sign a written informed consent document according to institutional guidelines.
- •All positive or negative ER (estrogen receptor), PR (progesterone receptor), and HER-2 subjects are eligible for this study.
- •However, subjects who are HER-2 positive and responsive to anti-HER-2 therapy (e.g. Herceptin), are encouraged to remain on anti-HER-2 therapy and not enroll in this trial.
- •Subjects who desire to enroll in this study and for whom anti-HER-2 therapy is not available or contraindicated, may be eligible to enroll in this trial.
- •In countries where continuous anti-HER2 therapy is considered standard of care for HER-2 positive metastatic disease, HER-2 positive subjects are not eligible.
- •Women of childbearing potential must be willing to implement adequate contraception during the study. An adequate method of contraception will be at the investigator's discretion.
排除标准
- •Subjects are pregnant or breast-feeding at entry.
- •Subjects with more than 2 events of disease progression after the development of metastatic breast cancer.
- •Subjects who are currently receiving any other concomitant anticancer therapy with the EXCEPTION of bisphosphonates and hormone therapy.
- •During the study period, subjects using hormonal therapy and bisphosphonates should maintain a constant dose and should not change existing regimen.
- •However, if a change in hormonal therapy is indicated, e.g. due to intolerable adverse effects, the regimen may be modified but change should be minimized thereafter.
- •Subjects with metastasis limited to the bone only are excluded. However, subjects with current metastasis limited to the bone only and with a history of distant metastasis are eligible. Subjects with current metastasis limited to the bone only and with current breast tissue lesion are eligible.
- •Subjects who have any history of other malignancy (except non-melanoma skin carcinoma and carcinoma-in-situ of the uterine cervix) within 5 years of study entry.
- •Subjects with splenectomy.
- •Subjects with HIV infection.
- •Subjects with any major autoimmune diseases or autoimmune disorders requiring systemic iv/oral steroids or immunosuppressive or immunomodulatory therapies.
- •e.g. Type 1 juvenile onset diabetes mellitus, antibody positive for rheumatoid arthritis, Grave's disease, Hashimoto's thyroiditis, lupus, scleroderma, systemic vasculitis, hemolytic anemia, immune mediated thrombocytopenia, etc
- •Autoimmune disorders confined to the skin (e.g. psoriasis) are eligible, and topical steroids are allowed for the treatment of such skin disorders.
- •Subjects with any known uncontrolled inter-current illness including ongoing or active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Subjects with any of the following MEDICATIONS within 4 weeks prior to randomization:
- •Anti-neoplastic agents
- •Immunotherapy [mAbs, Interferons, Cytokines (except GCSF)]
- •Immunosuppressants (e.g. Cyclosporin, Rapamycin, Tacrolimus, Rituximab, Alemtuzumab, Natalizumab, etc.).
- •Another investigational drug
- •Subjects with pleural effusions and/or ascites, due to malignancy, requiring paracentesis every 2 weeks or more frequently.
- •Subjects with any known severe allergies (e.g. anaphylaxis) to any active or inactive ingredients in the study drugs.
- •Subjects with bladder inflammation and urinary outflow obstruction.
研究组 & 干预措施
OPT-822/OPT-821 (30 μg/100 μg) and Cyclophosphamide
Experimental
Patients will be randomized 2:1 to receive OPT-822/OPT-821(30 μg/100 μg) plus Cyclophosphamide IV (300mg/m2).
干预措施: OPT-822/OPT-821(30 μg/100 μg) (Biological)
OPT-822/OPT-821 (30 μg/100 μg) and Cyclophosphamide
Experimental
Patients will be randomized 2:1 to receive OPT-822/OPT-821(30 μg/100 μg) plus Cyclophosphamide IV (300mg/m2).
干预措施: Cyclophosphamide (Drug)
Phosphate Buffer Saline (PBS) and Cyclophosphamide
Placebo Comparator
Patients will receive Phosphate Buffer Saline (PBS) plus Cyclophosphamide IV (300mg/m2).
干预措施: Phosphate Buffer Saline (PBS) (Biological)
Phosphate Buffer Saline (PBS) and Cyclophosphamide
Placebo Comparator
Patients will receive Phosphate Buffer Saline (PBS) plus Cyclophosphamide IV (300mg/m2).
干预措施: Cyclophosphamide (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: Progression or up to 2 years
次要结局
- Overall Survival (OS)(5 years)
研究者
研究点 (43)
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