CTIS2024-511264-89-00招募中1 期
Phase I/II trial of meclofenamate in progressive MGMT-methylated glioblastoma under temozolomide second-line therapy (MecMeth/ NOA-24) - NEU-201901
Rheinische Friedrich-Wilhelms-Universitaet Bonn0 个研究点目标入组 72 人开始时间: 2024年5月7日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 72
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
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •1. First relapse after first-line therapy with radiotherapy (RT) and alkylating chemotherapy, > 3 months after last chemotherapy application and >6 months after end of RT. Drug therapy and/or radiotherapy for first relapse treatment not yet started, 10. Adequate liver function (bilirubin <1.5 x ULN; ASAT /ALAT <3 x ULN, creat-inine < 1.5 x ULN, 11. Patient compliance and geographic proximity that allow adequate follow up, 12. Male and female patients with reproductive potential must use an ap-proved contraceptive method during and for 3 months after the trial (Pearl index <1%), 13. Pre-menopausal female patients with childbearing potential: a negative serum pregnancy test (beta-HCG) must be obtained prior to treatment start, Addition criterion for Phase II only: 14. Resection at first relapse not yet performed; according to the local treating neurosurgeon and the documented decision of local neurooncological tu-mor board, reresection of the tumor is clinically indicated and can be safe-ly deferred until day 7-10 after initiation of MFA/TMZ therapy, 2. Tumor progression according to RANO criteria, 3. Written informed consent, 4. Cognitive state to understand rationale and necessity of study therapy and procedures, 5. MGMT promotor-methylated (MGMTmeth), IDH wildtype glioblastoma (GBM) or gliosarcoma confirmed with histology of the primary resection or, in phase II, last resection, 6. Age > 18 years, 7. Karnofsky performance score (KPS) =60%;, 8. Life expectancy > 6 months, 9. Adequate bone marrow reserve (WBC >3 G/nl, platelets >100 G/nl
排除标准
- •1. Indication for hematotoxicity in first-line therapy not allowing TMZ starting dose 150 mg/m2/d, 10. Breastfeeding or pregnant, 11. Unable to undergo contrast-enhanced MRI (i.e. contrast allergy, implants, etc, 12. Treatment in another clinical trial with therapeutic medical intervention or use of any other investigational agent during the trial or within the 30 days before enrollment, 13. Medication with a drug that is not allowed in conjunction with MFA intake and cannot be discontinued: i.e. lithium, methotrexate, etc, 14. Patients with active bleeding, bleeding diathesis, antiplatelet therapy or anticoagulant therapy except for the following anticoagulants which are permitted for low-dose thrombosis prophylaxis up to the dosage speci-fied here: unfractionated heparin 7,500 IU BID or 5,000 IU TID; low molecu-lar weight heparin e. g. enoxaparin 40 mg/d; fondaparinux 2.5 mg/d; danaparoid sodium 750 IU BID; argatroban IV route thrombin time < 70 s; dabigatran 110 mg BID; rivaroxaban 10 mg/d; edoxaban 30 mg/d; epixa-ban 2.5 mg BID This restriction is due to a potentially increased risk of GI ulcers with subsequent bleeding under MFA therapy, 15. Patients with medically diagnosed hereditary Galactose Intolerance, com-plete lactase deficiency or confirmed Glucose-Galactose-Malabsorption, 16. Medical History of gastrointestinal Resection of any kind that may poten-tially alter the absorption of the investigational study drug, according to investigators judgement, 17. The presence of any other concomitant severe, progressive, or uncon-trolled renal, hepatic, hematological, endocrine, pulmonary, cardiac (in-cluding coronary artery bypass graft), or psychiatric disease, or signs and symptoms thereof, that may affect the subjects participation in the study, according to investigators judgement, 2. History of skin or liver toxicity >CTCAE5 grade 1 in first-line therapy, 3. History of gastrointestinal bleeding or gastroduodenal ulcer, active gastritis, 4. History of asthma, urticaria or allergic-type skin reactions to NSAID, 5. Prior malignancy other than glioma, 6. History of confirmed or suspected hypersensitivity (delayed type and im-mediate type, inclusive of anaphylactic reaction) to any background/ standard TMZ drug product or one of its ingredients of the chosen prod-uct, or to cyclooxygenase inhibitors (NSAIDs”), or to any ingredient of meclofenamate drug product, 7. History of disease with poor prognosis, 8. History of severe coronary heart disease (esp. after coronary artery bypass graft or history of myocardial infarction)or severe heart failure, 9. Known HIV infection, active hepatitis B or C
研究者
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