NL-OMON42197已完成2 期
A Mechanistic Study of Mifamurtide (MTP-PE) In Patients With Metastatic And/Or Recurrent Osteosarcoma - MEMOS
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 12 至 99（—）
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 or up to 65 (or 18 years and up 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)
排除标准
- •1. Pregnant or breast-feeding 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 (see section 5.1 Informed consent - Contraceptive/ Pregnancy counselling).
- •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 to first study biopsy
- •9. Currently taking high-dose non-steroidal anti-inflammatory 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 cone-biopsied 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.
研究者
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