ISRCTN82138287已完成2 期
A Mechanistic Study Of Mifamurtide (MTPPE) In Patients With Metastatic And/Or Recurrent Osteosarcoma
niversity of Oxford (UK)0 个研究点目标入组 40 人开始时间: 2014年9月18日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
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
- 性别
- All
入选标准
- •1. Relapsed osteosarcoma (first, second, third or any relapse, patient has recovered from chemotherapy and any other investigational drug/agent treatment, radiotherapy or surgical procedure).
- •2. Histological confirmed diagnosis of osteosarcoma at original presentation.
- •3. Tumour at biopsy accessible or resectable site.
- •4. Progressive disease documented by imaging within 3 months of entry into the trial.
- •5. At least one measurable lesion on CT scan (RECIST) performed in past 21 days prior to trial entry.
- •6. Male or female, age = 16 years to 65 (or =18 based on institutional practice for Teenage and Young Adult Cancer patients).
- •7. Life expectancy of at least 3 months.
- •8. WHO performance score of 0 - 2.
- •9. The patient is willing and able to comply with the protocol and scheduled follow-up visits and examinations.
- •10. Written (signed and dated) informed consent.
- •11. Cardiac shortening fraction = 28% or ejection fraction = 45%
- •12. Renal function is adequate for ifosfamide treatment (GFR as per table below, other renal function screening tests as per local practice)
- •13. Haematological and biochemical indices within the ranges detailed in the protocol
排除标准
- •1. Pregnant or breastfeeding woman. Men or women of childbearing potential unless effective methods of contraception are used during study treatment and for at least 7 days after the last mifamurtide dose.
- •2. Previous treatment with mifamurtide or a mifamurtide like drug* in a clinical trial setting for the treatment of metastatic and/or recurrent osteosarcoma in the six months prior to registration.
- •3. Contraindications to lung biopsies
- •4. Hypersensitivity to ifosfamide or any component of the formulation.
- •5. Previously diagnosed brain metastases.
- •6. Significant active cardiac disease including: uncontrolled high blood pressure (no greater than 2 standard deviations above the mean for age for systolic blood pressure (SBP) and diastolic blood pressure (DBP), unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, or serious cardiac arrhythmias and with a history of pericarditis and myocarditis
- •7. Treatment with any other investigational agent, or participation in another interventional clinical trial within 21
- •days prior to enrolment.
- •8. Major surgery within 21 days prior first study biopsy
- •9. Currently taking of high-dose nonsteroidal antiinflammatory drugs (NSAIDs) or corticosteroid treatment
- •10. Concurrent use of ciclosporin or other calcineurin inhibitors.
- •11. Any psychological, social or medical condition, physical examination finding or a laboratory abnormality that the Investigator considers would make the patient a poor trial candidate or could interfere with protocol compliance or the interpretation of trial results.
- •12. Any other active malignancy, with the exception of adequately treated conebiopsied in situ carcinoma of the
- •cervix uteri and non-melanoma skin lesions.
- •13. Patients who are known to be serologically positive for Hepatitis B, Hepatitis C or HIV.
- •* mifamurtide-like drugs include GMCSF, interferon and other macrophage activating molecules.
研究者
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