EUCTR2006-000753-22-GB进行中（未招募）1 期
A phase I/II feasability trial to assess the safety, immunological activity and efficacy of TroVax plus interferon alpha in patients with advanced or metastatic renal cell cancer.
Oxford MioMedica UK Ltd.0 个研究点目标入组 10 人开始时间: 2006年4月10日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 10
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
入选标准
- •Locally advanced or metastatic, histologically proven clear cell or papillary cell renal
- •If previously treated at least four weeks from any previous therapy (except Interferon a) for renal cancer includi,ng surgery chemotherapy, immunotherapy, or radiotherapy. (Patients receiving interferon a whose renal cancer is stable may also be included in the study)
- •Newly diagnosed or progressive of stable measurable disease as defined by the
- •RECIST criteria
- •Patients receiving first or second line treatment for locally advanced or metastatic renal cancer.
- •Patients on stable doses of bisphosphonates that show subsequent tumor progression may continue on this medication; however, patients are not allowed to initiate bisphosphonate therapy within one month prior to starting therapy or throughout the study.
- •Patients must be well enough to tolerate first or second line immunotherapy with
- •interferon alpha.
- •Measurable disease.
- •Aged 18 years or more.
- •Patients must comply with 2 out of 3 of the following:
- •a. Karnofsky score greater than or equal to 80%.
- •b. Haemoglobin concentration greater than or equal to 13g/dL (males) or 11.5 g/dL (females)
- •c. Corrected calcium less than or equal to 10 g/dL (2.5 mmols/L).
- •Clinically immunocompetent.
- •Free of clinically apparent autoimmune disease (including no prior confirmed diagnosis or treatment for autoimmune disease including Systemic Lupus Erythematosis, Grave's disease, Hashimoto's thyroiditis, multiple sclerosis, insulin dependant diabetes mellitus or systemic (non-joint) manifestations of rheumatoid disease).
- •Total white cell count greater than or equal to 3 x 10e9/L and lymphocyte count greater than or equal to 1 x 10e9/dL.
- •Serum creatinine up to 1.5 times upper limit of normal.
- •ALT, AST and bilirubin < 2 times the upper limit of normal.
- •Able to give written informed consent and to comply with the protocol.
- •Women must be either post menopausal, or rendered surgically sterile or, if of child
- •bearing potential, must have been practising a reliable form of contraception (oral
- •contraception + a barrier method) for at least three months prior to the first dose of
- •TroVax and must continue while they are being treated with TroVax. Men must
- •practise a reliable form of contraception while they are being treated with TroVax.
- •No acute changes on 12-lead ECG.
- •No clinical suspicion that cardiac ejection fraction is less than 45% (If clinically
- •suspicion exists the ejection fraction should be measured according to local site
- •procedures)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Serious infections within the 28 days prior to entry to the trial.
- •Prior TroVax
- •Patients that initiate bisphosphonate therapy within one month prior to starting therapy or throughout the study.
- •Already completed prior second line therapy for advanced or metastatic renal cancer.
- •(Note however that patients currently receiving interferon as second line therapy for
- •advanced or metastatic renal cancer who are stable (ie do not demonstrate response or progression by RECIST criteria) may enter the study)
- •Major surgery or radiation therapy completed less than or equal to 4 weeks prior to enrollment.
- •Prior radiopharmaceuticals (strontium, samarium) within 8 weeks prior to enrollment.
- •Participation in any other clinical trial of a licensed or unlicensed drug within the
- •previous 30 days. (except sorafanib or sutnitinib who may enter the study after 7 days discontinuation)
- •Cerebral metastesis on MRI scan
- •Currently active second malignancy, other than non-melanoma skin cancer. Patients are not considered to have a currently active malignancy if they have completed therapy and are considered by their physician to be at least less than 30% risk of relapse.
- •Serious intercurrent infections or nonmalignant medical illnesses that are uncontrolled.
- •Psychiatric illnesses/social situations that would limit compliance with protocol
- •requirements.
- •Creatinine 21.5 x ULN.
- •Chronic oral corticosteroid use unless prescribed as replacement therapy in the case
- •of adrenal insufficiency.
- •Clinical indication of reduced cardiac function or an ejection fraction of r 40%.
- •Requirement for radiotherapy (this is a sign of disease progression and is classed as a withdrawal criterion).
- •Concurrent chemotherapy, immunotherapy and radiation therapy
- •No investigational or commercial agents or therapies other than those included in protocol treatment may be administered with the intent to create regression of the
- •patient's malignancy.
- •Life threatening illness unrelated to cancer.
- •Cerebral metastases on MRI scan.
- •History of allergic response to previous vaccinia vaccinations.
- •Participation in any other clinical trial of a licensed or unlicensed drug within the
- •previous 30 days or during the course of this trial.
- •Previous malignancies within the last 10 years other than successfully treated
- •squamous carcinoma of the skin or in situ carcinoma of the cervix treated with cone
- •Previous history psychosis or of major a psychiatric disorder requiring hospitalization or any current psychiatric disorder that would impede the patient's ability to provide
- •informed consent or to comply with the protocol.
- •Known allergy to egg proteins.
- •Known to test positive for HIV or hepatitis B or C.
- •Pregnancy or lactation.
- •Prior history of organ transplantation.
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