EUCTR2016-001256-22-PL进行中（未招募）1 期
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Determine the Safety and Efficacy of GL-0817 (with Cyclophosphamide) for the Prevention of Recurrence in HLA-A2+ Patients with High-Risk Squamous Cell Carcinoma of the Oral Cavity
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Gliknik Inc.
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Age = 18 years
- •2. Histologic diagnosis of squamous cell carcinoma of the oral cavity including the lip, floor of mouth, anterior 2/3 of tongue, alveolus and gingiva, buccal mucosa, hard palate and retromolar trigone
- •3. Patients must have undergone primary gross total resection (no re-resected patients are allowed) with fulfillment of at least 1 of the following histologic criteria for high-risk disease:
- •Histologic involvement of 2 or more regional lymph nodes
- •Any lymph node with histologic extracapsular extension (ECS)
- •Close (<3mm) or positive surgical margins on microscopic evaluation with no gross residual tumor
- •4. No evidence of locoregional disease or distant metastases at screening. Subjects must have negative scans (CT, CT-PET or MRI) for locoregional recurrence, brain or lung metastases. A negative biopsy will be mandated in patients with a positive scan. Other evaluations should be performed as clinically indicated.
- •5. No history of distant metastases.
- •6. Tumor tissue from surgery or biopsy must be available to determine MAGE-A3 expression for correlative studies.
- •7. Following surgery, the patient must have received external beam radiotherapy (58-66 Gy in 2 Gy fractions, 5 days per week) with concomitant cisplatin starting within 8 weeks of surgery. A brief delay in the initiation of radiotherapy following 8 weeks post-surgery due to administrative reasons (e.g., start of RT on Mondays) may be permitted by the Medical Monitor. The cumulative dose of cisplatin the subject received must be = 150 mg/m^2. Protocol therapy must be initiated within a period of 4-8 weeks (28-56 days) following the end of RT.
- •8. The patient is, in the investigator’s opinion, adequately recovered from the effects of surgery and chemoradiotherapy to participate in this study.
- •9. Blood HLA-A2 phenotype
- •10. ECOG Performance Status = 1
- •11. Laboratory values obtained = 14 days prior to randomization:
- •Absolute neutrophil count (ANC) = 1500/µL (without intervention, e.g., G-CSF)
- •Platelets = 75,000/µL (without intervention, e.g., transfusion)
- •Hemoglobin = 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb =8.0 g/dl is acceptable).
- •Alkaline phosphatase = 2.5 x upper limit of normal (ULN)
- •AST and ALT = 2 x ULN
- •Creatinine < 2 x ULN
- •Bilirubin < 1.5x ULN (except for patients with Gilbert’s disease, for whom the upper acceptable limit of serum bilirubin is 3mg/dL)
- •12. A female subject is eligible to enter the study if she is:
- •not pregnant or nursing; Female participants must not breastfeed during the study and for a period of 30 days following the last dose.
- •of non-childbearing potential (i.e., women who had a hysterectomy, are postmenopausal which is defined as 1 year without menses, have both ovaries surgically removed or have current documented tubal ligation); or
- •of childbearing potential (i.e., women with functional ovaries and no documented impairment of oviductal or uterine function that would cause sterility). This category includes women with oligomenorrhea [even severe], women who are perimenopausal or have just begun to menstruate. These women must have a negative serum pregnancy test at screening, and agree to one of the following:
- •- complete abstinence from intercourse from 2 weeks prior to administration of the 1st dose of study agent and 6 months after the last dose of study agent; or
- •- consistent and correct use of 1 of the following highly effective methods of birth
排除标准
- •1. Known HIV or hepatitis B/C infection (testing not required). Subjects who are hepatitis C antibody positive may be enrolled if they are confirmed to have a negative viral load at screening.
- •2. Subjects with active autoimmune disease or a history of autoimmune disease requiring systemic steroids or other immunosuppressive treatment.
- •3. Subjects who have used systemic corticosteroids or other immunosuppressants for any condition within 14 days of randomization. Inhaled or topical steroids are permitted.
- •4. Any medical condition which would, in the investigator’s opinion, compromise the patient’s ability to mount an immune response, renders the patient a poor candidate for this trial or could confound the results of the study
- •5. Major surgery or traumatic injury within 28 days of randomization
- •6. Prior splenectomy or organ allograft
- •7. Any other prior, concurrent or planned chemotherapy, immunotherapy, radiotherapy, device, or investigational therapy for this cancer other than those specified in this study.
- •8. History of other malignancy (i.e., excluding disease under study) within 3 years of randomization. Exceptions include: adequately-treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix or breast, or adequately treated non-metastatic prostate cancer.
- •9. Known hypersensitivity to GM-CSF, yeast-derived products or any component of the GM-CSF drug product (e.g., mannitol) or poly-ICLC (e.g., carboxymethylcellulose).
- •10. Known hypersensitivity to cyclophosphamide, its metabolites or any other components, or known urinary outflow obstruction.
研究者
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