combined effect of temozolomide with nilotinib and temozolomide alone on newly diagnosed human glioblastoma multiform tumor
Phase 1
Recruiting
- Conditions
- Glioblastoma multiforme.Malignant neoplasm of brain
- Registration Number
- IRCT20140120016280N6
- Lead Sponsor
- ational Institute for Medical Research Development (NIMAD)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
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
Exclusion Criteria
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method 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.