CTRI/2010/091/001232已完成2 期
A Randomized, Active Therapy Controlled Phase 2 Study to Assess the Safety and Efficacy of ADXS11-001 with and without Cisplatin as 2nd Line Therapy for the Treatment of Recurrent Cervix Cancer
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Advaxis Inc
- 入组人数
- 110
- 试验地点
- 19
- 主要终点
- To determine the safety and efficacy ADXS11-001 with or without chemotherapy in patients with recurrent or progressing cervix cancer who have failed prior cytotoxic treatment.
研究概览
简要总结
This study is designed to assess the safety and efficacy of a vaccine regimen comprised of three doses of ADXS11-001 followed by antibiotics subsequent to each dose compared to accepted standard therapy consisting of cisplatin in patients with advanced cervixcancer who have failed cytotoxic therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Female
入选标准
- •Female patients 18-60 years of age capable and willing to provide informed consent according to national, state and institutional guidelines indicating that they are aware of the investigational nature of the study, and who agree in writing to comply with the requirements for participation in this study.
- •Patients who are capable of reproduction and agree to take oral contraceptives for the duration of the study are acceptable for entry into this trial.
- •Patients must have documented, recurrent or progressing invasive cervix cancer subsequent to treatment with prior cytotoxic treatment consisting of chemotherapy, radiotherapy or both that is confirmed by CT scan or radiological scan.
- •Patients must have measurable disease, which is defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be 20 mm when measured by conventional techniques,recorded).
- •Each lesion must be 10 mm when measured byincluding palpation, plain x-ray, CT, and MRI, or spiral CT.
- •Patients must have at least one ?target lesion?
- •to be used to assess response on this protocol as defined by RECIST.
- •Tumors within a previously irradiated field will be designated as ?non-target?
- •lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy.
- •Eastern 2 (Karnofsky Indexï‚£Cooperative Oncology Group (ECOG) performance status 60%).
- •Patients must have adequate:a.
- •Bone marrow function: Platelet count greater than or equal to 100,000/mcl and ANC count greater than or equal to 1,500/mcl, equivalent to CTCAE v4.0 grade 1.b. Renal function: Creatinine less than or equal to 1.5 x institutional upper limit normal (ULN), CTCAE v4.0 grade
- •Neurologic function: Neuropathy (sensory and motor) less than or equal to CTCAE v4.0 grade
- •Only patients with squamous cell carcinoma of the cervix are acceptable for entry into this trial.
- •Patients must respond positively to at least one of the test agents used in the anergy panel described in Appendix D.
- •A positive reaction defined by the formation of a local tissue response of at least 5 mm in sum of the orthogonal measures in reaction to the administration of a delayed hypersensitivity stimulus as described Appendix D is required for patient entry.
排除标准
- •Patients with a history of other invasive malignancies,
- •The use of any investigational agent(s) for 28 days prior to dosing with ADXS11-001,
- •The use of any therapeutic agent for the treatment of cervix cancer other than the drugs specified within this protocol during the time a patient is enrolled in this trial will preclude that patient from receiving further study doses.
- •Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis other than for the treatment of cervix cancer within the last five years,
- •Patients with brain metastases,
- •Prior biologic therapy,
- •A history of listeriosis,
- •Uncontrolled intercurrent illness including, but not limited to, 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,
- •The use of concomitant antibiotics or antibiotics within the past month,
- •Any disease that requires treatment with immunosuppressive drugs.
- •The use of topical corticosteroids and inhaled steroids are not allowed in this study,
- •Hepatitis, cirrhosis, or any other impaired hepatic function as indicated by elevated liver function test serum enzymes.
- •Liver function tests must be within normal range based upon laboratory certification to be allowed into the study.
- •Pregnant women, women actively trying to become pregnant, and nursing women are excluded from this study because ADXS11-001 is a biologic agent with the potential for teratogenic or abortifacient effects.
- •HIV-positive patients are excluded from the study.
- •Patients whose HIV status is not known to the Investigator will be tested to assure HIV negativity.
- •A positive urine test for any drug of abuse, including but not limited to, marijuana, cocaine, and opiates.
结局指标
主要结局
To determine the safety and efficacy ADXS11-001 with or without chemotherapy in patients with recurrent or progressing cervix cancer who have failed prior cytotoxic treatment.
时间窗: 1 Year
次要结局
- To determine the immuno-stimulatory activity of ADXS11-001 in Patients with recurrent cervix cancer that have failed prior cytotoxic treatment.(1 Year)
研究者
研究点 (19)
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