CTRI/2013/06/003778暂停2 期
A Double-blind, Randomized Phase II/III Trial of Active Immunotherapy with Globo H-KLH (OPT-822) in Subjects with Metastatic Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 入组人数
- 342
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Female subjects >=21 years of age with histological or cytological diagnosis of breast cancer.
- •2. Subjects with metastatic breast cancer who have achieved stable disease (SD), partial
- •response (PR), or complete response (CR) after at least 1 regimen of chemotherapy.
- •3. Subjects must have recovered from toxicities of prior therapies. (i.e. CTCAE - grade 2).
- •4. Performance status: ECOG - 1 and life expectancy - 3 months.
- •5. Organ Function Requirements â?? Subjects must have adequate organ functions as defined
- •- AST/ALT <= 3X ULN (upper limit of normal)
- •- AST/ALT ï?£ 5X ULN [with underlying Liver Metastasis]
- •- Total Bilirubin ï?£ 2.0 X ULN
- •- Serum Creatinine ï?£ 1.5X ULN
- •- ANC - 1500 /μL
- •- Platelets > 100,000/μL
- •- No Symptomatic Congestive Heart Failure (Ejection Fraction EF ï?³ 50%)
- •6. Ability to understand and the willingness to sign a written informed consent document
- •according to institutional guidelines.
- •7. All positive or negative ER (estrogen receptor), PR (progesterone receptor), 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.
- •8. Women of childbearing potential must implement adequate contraception in the opinion of the investigator.
排除标准
- •1. Subjects are pregnant or breast-feeding at entry.
- •2. Subjects with more than 2 events of disease progression (PD) after the development of
- •metastatic breast cancer.
- •3. 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.
- •4. Subjects with metastasis limited to the bone only and with no history of other visceral or
- •soft tissue metastases.
- •5. Subjects with evidence or history of CNS metastases.
- •6. Subjects who have any history of other malignancy (except basal cell skin carcinoma and
- •carcinoma-in-situ of the uterine cervix) within 5 years of study entry.
- •7. Subjects with splenectomy.
- •8. Subjects with HIV infection.
- •9. 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,
- •Graveâ??s disease, Hashimotoâ??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.
- •10. Subjects with any known uncontrolled inter-current illness including ongoing or active
- •infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
- •arrhythmia, or psychiatric illness/social situations that would limit compliance with study
- •requirements.
- •11. Subjects with any of the following MEDICATIONS within 4 weeks prior to randomization:
- •- Anti-neoplastic agents
- •- Immunotherapy [mAbs, Interferons, Cytokines (except GCSF)]
- •- Immunosuppressants (Cyclosporin, Rapamycin, Tacrolimus, Rituximab, etc.)
- •- Another investigational drug
- •12. Subjects with pleural effusions and/or ascites requiring paracentesis every 2 weeks or more frequently.
- •13. Subjects with any known severe allergies (e.g. anaphylaxis) to any active or inactive
- •ingredients in the study drugs.
研究者
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