Recurrent Glioblastoma Clinical Trial
Official title:
Phase I Clinical Trial of Nasal Spray in Treating Patients With Recurrent Glioblastoma, Gliosarcoma, Glioma
This is a study to determine the efficacy, safety and clinical benefit (how well the drugs
works), of the pharmaceutical compositions in Nasal Spray NST-4G for the treatment of brain
tumors( Recurrent Glioblastoma, Gliosarcoma,Anaplastic Gliomas, Previously Treated).
All drugs target the inhibition of the growth factors and neo-angiogenesis as one the main
reasons for the growth of the tumor.
The purpose of the Nasal Spray NST-4G study is to determine the safety and tolerability in
order to establish the best dose level to be used in future studies.
This is an open-label study, Phase 1 study evaluating the preliminary safety, efficacy,
tolerability and clinical benefit of Nasal Spray NST-4G in patients with Recurrent
Glioblastoma, Gliosarcoma,Anaplastic Gliomas.
Acceptable subjects included in the study will receive Nasal Spray NST-4G, administered twice
daily for 7 weeks intranasally.
Every 8th day, a blood function (hematopoiesis) is examined . Patients may continue to
receive subsequent nasal spray cycles if the subject is not intolerant of the test product,
does not withdraw consent or the individual no longer receives clinical benefit (the factors
taken for consideration will be the progression of the disease, expressed in increasing
neuropathy, hemiparesis, pain intensification ,DLT events, Clinical signs of deteriorating
quality of life (QOL).
The evaluation of the tumor size will be repeated using the MRI method with a contrast agent
after each 7-week nasal spray cycle.
The use of nasal spray is a non-invasive method of treatment that does not require
specialized conditions for therapy
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