EUCTR2013-001132-22-ES进行中（未招募）1 期
A MULTICENTER, SINGLE ARM, PHASE 2 CLINICAL STUDY ON THE COMBINATION OF RADIATION THERAPY AND IPILIMUMAB, FOR THE TREATMENT OF PATIENTS WITH MELANOMA AND BRAIN METASTASES. - GRAY B
Grupo Español Multidisciplinar de Melanoma0 个研究点目标入组 66 人开始时间: 2014年1月9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
- 66
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) Willing and able to give written informed consent.
- •2) Histologic diagnosis of melanoma.
- •3) First episode of radiological evidence of brain metastases
- •4) Age>18 years.
- •5) RTOG-RPA class 2 (Appendix 1)
- •6) Karnofsky performance status (PS) > 70%.(Appendix 2)
- •7) Barthel Index of Activities of Daily Living > 10 (Appendix 3)
- •8) Measurable disease (mWHO criteria).
- •9) Adequate organ function as determine by the following criteria:
- •a. WBC >/= 2000/uL
- •b. Absolute neutrophil count (ANC) >1.5 x 109/L.
- •c. Platelet count >75 x 109/L.
- •d. Hemoglobin >9 g/dL. If the patient received a RBC transfusion, the required value of hemoglobin should be met at least 1 week after the most recent transfusion.
- •e. Serum creatinine f. Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) g. Total bilirubin h. Albumin > 2.5 g/dL
- •10) Persons of reproductive potential must agree to use an adequate method of contraception throughout treatment and for at least 26 weeks after ipilimumab is stopped:
- •a. WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not post-menopausal. WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours before the start of ipilimumab. If the pregnancy test is positive, the patient must not receive ipilimumab and must not be enrolled in the study. Before study enrollment, women of childbearing potential (WOCBP) must be advised of the importance of avoiding pregnancy during study participation and the potential risk factors for an unintentional pregnancy. WOCBP must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 26 weeks after the last dose of investigational product, in such a manner that the risk of pregnancy is minimized. In general, the decision for appropriate methods to prevent pregnancy should be determined by discussions between the investigator and the study subject.
- •Post-menopause is defined as:
- •i. Amenorrhea >/=12 consecutive months without another cause, or
- •ii. For women with irregular menstrual periods and taking hormone replacement therapy (HRT), a documented serum follicle stimulating hormone (FSH) level >/= 35 mIU/mL.
- •Women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where their partner is sterile (eg, vasectomy) should be considered to be of childbearing potential.
- •b. Men of fathering potential must be using an adequate method of contraception to avoid conception throughout the study, and for up to 26 weeks after the last dose of investigational product in such a manner that the risk of pregnancy is minimized.
- •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 66
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 66
排除标准
- •1) Patients with melanoma and brain metastases with any of the following disease-specific characteristics:
- •a.Documented evidence of prior progression of melanoma to an ipilimumab-containing regimen (i.e. received at least 2 doses of ipilimumab for either advanced disease or in the adjuvant setting and the disease progressed/relapsed -according to mWHO criteria- within 24 weeks since the first dose of ipilimumab)
- •b.Prior radiation therapy to the brain
- •c.Other prior antineoplastic therapies for brain metastases.
- •d.Patients with cerebral metastases as the only location of the disease, for which local therapy (neurosurgery, radiosurgery) could achieve a disease-free status
- •e.Patients with a rapid clinical deterioration, or with risk of herniation, or who require unstable ascending dosing of supportive medication in the last week -including anti-convulsivants, steroids and analgesics-, or who require dexamethasone > 16 mg/d (or other glucocorticoid at an equipotent dose), or with a high LDH (> 2 x ULN).
- •2)Any other malignancy form which the patient has been disease-free for less than 5 years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix, or incidental prostate cancer.
- •3)Uncontrolled diabetes mellitus (HbA1c > 9%)
- •4)Autoimmune disease other than vitiligo or past thyroiditis under substitutive hormone therapy: Patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn?s Disease, are excluded from this study, as are patients with a history of symptomatic disease (eg, rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [eg, Wegener?s Granulomatosis]); motor neuropathy considered of autoimmune origin (e.g. Guillain-Barre Syndrome and Myasthenia Gravis).
- •5)Other chronic intestinal diseases associated with diarrhea.
- •6)Active infection or other serious illness or medical condition.
- •7)Known active or chronic infection with HIV, Hepatitis B, or Hepatitis C.
- •8)Treatment with any of the following medications: IL-2, interferon or other immunotherapies, cytotoxic chemotherapy, immunosuppressants; inhibitors of molecular targets (eg, BRAF, MEK, KIT), Or chronic use of systemic corticosteroids (for the treatment of unrelated to cancer) diseases concomitantly or within 3 weeks prior to start of treatment.
- •9)Any experimental therapy administered in the past 30 days prior to the beginning of the treatment.
- •10)Any non-cancer vaccine therapy used for the prevention of infectious diseases (up to 4 weeks before any dose of study drug).
- •11)Women of childbearing potential (WOCBP), as defined above in 'Inclusion criteria', who:
- •a. are unwilling or unable to use an acceptable method of contraception to avoid pregnancy for their entire study period and for at least 26 weeks after cessation of study drug, or
- •b. have a positive pregnancy test at baseline, or
- •c. are pregnant or breastfeeding.
- •12)Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (eg, infectious) illness.
- •13)Any other general, medical or psychological conditions which in the opinion of the investigator will make the administration of ipilimumab hazardous, or that would preclude appropriate informed consent or compliance with the protocol, or obscure the interpretation of eventual AEs.
研究者
相似试验
招募中
2 期
The R- 100 ITP Study : evaluating the efficacy of a single weekly dose of 100mg of Rituximab over 4 weeks in patients with refractory or relapsing idiopathic thrombocytopaenic purpuraIdiopathic thrombocytopaenic purpuraBlood - Haematological diseasesACTRN12612000591853Florence Peterson Fund50
进行中（未招募）
1 期
The study will evaluate the safety and efficacy of a combined therapy consisting of immuntherapy and radiation prior to radical cystectomy in patients with locally advanced urothelial bladder cancerEUCTR2018-001823-38-DETechnische Universität München, Fakultät für Medizin vertreten durch den Dekan33
招募中
不适用
A multicenter, single arm phase 2 study to examine efficacy and cerebrospinal fluid transitivity of Osimertinib in leptomeningeal carcinomatosis (LMC) patients with non-small cell lung cancer harboring EGFR mutatioJPRN-UMIN000023710HANSHI15
招募中
1 期
A multicenter single-arm phase II interventional study to evaluate the activity and safety of the combination of Platinum-Pemetrexed based chemotherapy plus Lorlatinib in ALK positive Non-Small Cell Lung Cancer (NSCLC) with exclusively extracranial disease progression on LorlatinibALK positive Non-Small Cell Lung CancerMedDRA version: 21.1Level: PTClassification code: 10029522Term: Non-small cell lung cancer stage IV Class: 100000004864CTIS2023-506714-43-00Centro Di Riferimento Oncologico Di Aviano45
进行中（未招募）
1 期
Safety evaluation of neoadjuvant Myocet® plus paclitaxel, trastuzumab, and pertuzumab in patients with operable HER2-positive breast cancerHER2-positive breast cancerMedDRA version: 14.1Level: LLTClassification code 10065430Term: HER-2 positive breast cancerSystem Organ Class: 100000004864EUCTR2012-001201-24-ESSOLTI83