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IRCT20140120016280N6 IRCT 2022-04-16 National Institute for Medical Research Development (NIMAD) combined effect of temozolomide with nilotinib and temozolomide alone on newly diagnosed human glioblastoma multiform tumor Comparative study of the combined effect of temozolomide with nilotinib and temozolomide alone on non-surgical newly diagnosed human glioblastoma multiform tumor: A phase I-II, controlled, placebo, randomized, triple-blinded clinical trial 2022-03-09 anticipated 20 Complete https://irct.ir/trial/62324 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomly assigned to receive nilotinib or placebo by ratio 1:1. Block randomization through computer-generated codes is performed using Sealed Envelope website (www.sealedenvelope.co) with block size: 4 and list lenght: 20 by researcher who not directly involved in the analysis of the study results. Hence, the randomization sequence will be sealed with same envelopes and provided to main investigator. The schedule will be provided to the Pharma Co. and sealed envelopes containing the treatment allocation of each randomization code will be provided to the main investigator in case of emergency, Blinding description: Nilotinib and placebo capsules, which are exactly the same in appearance, are prepared by the manufacturer and in the form of A and B capsules by a person (company representative) who only knows the contents of the capsules, is provided to the therapist (radio oncologist). The therapist researcher assigns patients into two groups A and B, using randomized envelopes. The evaluations, data collection, and final analysis will be performed by researchers who are unaware of patients' assignments to drug groups and contents. After the final analysis, the company representative will be asked to specify the contents of the drugs. Therefore, patients, researchers, and the final analyzer do not know about the allocation of patients to treatment groups in this study; hence, the study will be three-blinded. 1-2 Glioblastoma multiforme. Intervention 1: Intervention group: The standard radiation therapy regimen will be performed in 30 sessions with a total dose of 60 Gy (2 Gy per session). Also, chemotherapy regimen with temuzolamide (75 mg / m2) will be performed daily during radiation therapy for all patients. Then you will be given a rest for 3 weeks. Temuzolamide capsules (150-200 mg / m2) will then be administered for 5 days in each 28-day cycle for 6 periods.Nilotinib capsules 200 mg (Sobhan Oncology Pharma Co.) daily during the chemotherapy phase (28 days in each 28-day cycle). Intervention 2: Control group: The standard radiation therapy regimen will be performed in 30 sessions with a total dose of 60 Gy (2 Gy per session). Also, chemotherapy regimen with temuzolamide (75 mg / m2) will be performed daily during radiation therapy for all patients. Then you will be given a rest for 3 weeks. Temuzolamide capsules (150-200 mg / m2) will then be administered for 5 days in each 28-day cycle for 6 periods. Placebo capsule (prepared by Sobhan Oncology Pharma Co.) with the same appearance and similar to Nilotinib capsule and will be used daily during the chemotherapy phase (28 days in each 28-day cycle) for 6 cycles. Yes - There is a plan to make this available What will be shared: The analyzed data will be published in the form of a scientific article. However, basic data can only be provided to specific individuals or organizations in specific cases. When: Since publication To whom: Researchers and health authorities Conditions: Review by relevant organizations and health decision makers Where to obtain: Scientific Officer of Study How to obtain: Written request to the scientific director of the study Comments:
public Ehsan Jangholi
North Kargar St., Jalal Al-Ahmad Intersection, Shariati Hospital
Tehran Iran (Islamic Republic of) 1411713135 +98 21 8490 2380 ehsanjangholi@yahoo.com Tehran University of Medical Sciences scientific Mahmoud Reza Hajighasem
End of Keshavarz Boulevard, Imam Khomeini Hospital, Reyhaneh Building
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6658 1560 mhadjighassem@tums.ac.ir Brain and Spinal Cord Injury Research Center, Neuroscience Institute Iran (Islamic Republic of) Age of 18 years and more Has newly diagnosis of GBM as determined by MRI findings. Tumors of deep and non-surgical areas Candidate for non-surgical treatment or biopsy 18 years no limit Both Age under 18 years Pregnancy Breastfeeding Hepatic or renal dysfunction Infection Concomitant with other brain diseases Existence of metastasis Psychosis and cognitive impairment Autoimmune diseases Patients undergoing brain surgery Ischemic heart disease Receiving other chemotherapy drugs or immunosuppressants during the last three months C71 Malignant neoplasm of brain Treatment - Drugs Placebo Intervention group: The standard radiation therapy regimen will be performed in 30 sessions with a total dose of 60 Gy (2 Gy per session). Also, chemotherapy regimen with temuzolamide (75 mg / m2) will be performed daily during radiation therapy for all patients. Then you will be given a rest for 3 weeks. Temuzolamide capsules (150-200 mg / m2) will then be administered for 5 days in each 28-day cycle for 6 periods.Nilotinib capsules 200 mg (Sobhan Oncology Pharma Co.) daily during the chemotherapy phase (28 days in each 28-day cycle). Control group: The standard radiation therapy regimen will be performed in 30 sessions with a total dose of 60 Gy (2 Gy per session). Also, chemotherapy regimen with temuzolamide (75 mg / m2) will be performed daily during radiation therapy for all patients. Then you will be given a rest for 3 weeks. Temuzolamide capsules (150-200 mg / m2) will then be administered for 5 days in each 28-day cycle for 6 periods. Placebo capsule (prepared by Sobhan Oncology Pharma Co.) with the same appearance and similar to Nilotinib capsule and will be used daily during the chemotherapy phase (28 days in each 28-day cycle) for 6 cycles. In this study, all the adverse event of nilotinib will be recorded based on the Common Terminology Criteria for Adverse Events (CTCAE). Timepoint: 1. Weekly in radiation phase 2. Every four weeks in chemotherapy phase. Method of measurement: Blood tests, including a complete blood cell count, creatinine and blood urea, creatine phosphokinase, and liver function test, echocardiography, and electrocardiogram every. Overall survival. Timepoint: Every 4 weeks. Method of measurement: History taking. Progression-free survival. Timepoint: Every 3 months. Method of measurement: Brain MRI with contrast. Karnofski performance score. Timepoint: Every 4 weeks. Method of measurement: Monthly visit with KPS questionnaire. Sobhan Oncology Pharma National Institute for Medical Research Development (NIMAD) Sobhan Oncology Pharma Approved 2021-11-30 Research Ethics Committees of National Institute for Medical Research Development No. 21, beginning of Besat St., West Fatemi St., National Institute of Medical Research Development of Iran (NIMAD) Tehran Tehran Iran (Islamic Republic of)