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

Determination of advers evvents, survival, and functional status of patients with newly diagnosed glioblastoma treated with temuzolamide regimen and radiotherapy with and without nilotinib

Clinical trial with control group, with parallel groups, triple blind, randomized, phase 1-2, on 20 patients. The block randomization method will be used for randomization.

In all patients referred to Shariati Hospital in Tehran (based on inclusion and exclusion criteria), the standard radiation therapy regimen is performed in 30 sessions with a total dose of 60 Gy (2 sessions 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. Patients in groups A and B will then receive one of the two capsules of nilotinib 200 mg daily during the chemotherapy phase (28 days per 28-day cycle) or placebo, which will be prescribed in the same way.

Patients over 18 years of age diagnosed with glioblastoma tumor without previous history of surgery, concomitant tumor, renal and hepatic impairment, and immunodeficiency. Pregnant and lactating women will also be excluded.

Drug group: Nilotinib capsules 200 mg daily during the chemotherapy phase (28 days per 28-day cycle) Darnama group: The placebo capsule will be prescribed with the same appearance and similar to the drug

Side efect of nilotinib

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.

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.

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.

Since publication

Researchers and health authorities

Review by relevant organizations and health decision makers

Scientific Officer of Study

Written request to the scientific director of the study