CTRI/2022/01/039501尚未招募未知
A randomized controlled study comparing tyrosine kinase inhibitor versus tyrosine kinase inhibitor with intrathecal methotrexate in leptomeningeal carcinomatosis in driver mutated non-small cell lung carcinoma - TYKME
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
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
入选标准
- •1. Subjects must have leptomeningeal metastasis from a driver mutated NSCLC. The diagnosis of LMM will be based on EANO criteria16. Patients with either confirmed or probable LMM disease status will be included in this study
- •2. Age: Male or female subjects aged = 18 years.
- •3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-3.
- •4. Subjects must have normal organ and marrow function as per TMH
- •5. Patients with HIV are potentially eligible, as long as they have a CD4 count > 200, are on concurrent HAART (highly active antiretroviral therapy), and have absence of active AIDS defining conditions.
- •6. Both men and women of all races and ethnic groups are eligible for this study.
- •7. Willing and able to comply with all study requirements, including treatment, able to be followed up at regular intervals and/or nature of required assessments.
- •8. Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •1. Subjects who are receiving any other investigational agents.
- •2. Within 2 weeks of administration of a chemotherapeutic agent.
- •3. Current use of immunosuppressive medication, EXCEPT for the following: a. intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection); b. Systemic corticosteroids at physiologic doses = 10 mg/day of prednisone or equivalent; c. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication) d. Steroids for raised intracranial pressure due to the disease itself e,Steroid use for avoidance or treatment of emesis.
- •4. Active autoimmune disease that might deteriorate when receiving a chemotherapeutic agent. Patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment are eligible.
- •5. Prior organ transplantation including allogeneic stem-cell transplantation.
- •6. Active infection requiring systemic therapy.
- •7. Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI-CTCAE v4.03 Grade = 3).
- •8. Clinically significant (i.e., active) cardiovascular disease: cerebrovascular accident/stroke ( < 6 months prior to enrollment), myocardial infarction ( < 6 months prior to enrollment), unstable angina, congestive heart failure (= New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication.
- •9. Pregnant and lactating women are excluded from this study.
- •10. Local site infection making it infeasible for lumbar puncture
- •11. Persistent features of raised intracranial pressure which has not subsided post steroids, mannitol and other decongesting interventions thus ruling out option of lumbar puncture
研究者
相似试验
招募中
不适用
Comparison of L-Thyroxine plus Liothyronine with L-thyroxine alone in post-surgical hypothyroidismEndocrine, nutritional and metabolic diseaseKCT0002600Asan Medical Center200
招募中
2 期
Clinical trial study of the therapeutic effect of Ivermectin, besides Kaletra and Chloroquinein in patients with Coronavirus disease 2019 (COVID-19)IRCT20200422047168N2Ahvaz University of Medical Sciences60
已完成
不适用
A randomised controlled trial comparing taurolidine-citrate with heparin for locking tunnelled haemodialysis cathetersChronic Renal Failure requiring treatment with regular haemodialysisUrological and Genital DiseasesISRCTN13630682orth Glasgow University NHS Division (UK)164
已完成
3 期
A comparison of body lotion containing Dead Sea minerals to two body lotions without Dead Sea minerals in the treatment of skin problems in hemodialysis patientsSkin - Dermatological conditionsuremic pruritusACTRN12610000741088Ahava Dead Sea Laboratories and Dead Sea Research Center75
尚未招募
2 期
A clinical trial to study the effect of myoinositol based therapy in combination with metformin as compared to metformin alone in women with polycystic ovarian syndromeCTRI/2021/03/032468Roshan Nazirudeen