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Keep this study
Lead
Yael P Mosse
With
Novartis Pharmaceuticals
Foundation Medicine
Age
1–21
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Aged ≥1 years to ≤ 21 years
Relapsed or refractory neuroblastoma
A sufficient interval between the last dose of prior anti-cancer therapy (including cytotoxic and biological therapies) and enrollment in this study, to allow recovery from the acute toxic effects of all prior anti-cancer therapy. Please contact site for specific details
Adequate bone marrow function (bone marrow may be involved with tumor. Contact site for specific details)
Adequate renal function, defined as Creatinine clearance or radioisotope glomerular filtration rate (GFR) ≥ 70 mL/min/1.73 m2 OR serum creatinine based on age/gender normal (contact site for details)
Adequate liver function, defined as total serum bilirubin ≤ 1.5 times the upper limit of normal AND alanine transaminase (ALT) ≤ 110 U/L.
Adequate cardiac function, defined as corrected QT interval (QTc) ≤ 480 msec AND shortening fraction \> 27%
Males and females who are sexually active must agree to use effective contraception during and for 3 months after treatment
You may not be if
Subjects taking certain drugs or herbal medications that impact drug metabolism and/or cardiac function that cannot be discontinued (contact site for details).
Subjects with concurrent severe and/or uncontrolled concurrent medical conditions that could compromise participation in the study (contact site for details)
Other concomitant therapies:
Corticosteroids initiated for tumor therapy within 7 days prior to study enrollment
Other anti-cancer agents
Other investigational drugs
Hematological growth factors
Radiation therapy
Subjects \< 0.5m2
Pregnant or lactating females
Sexually active males unless they use a condom during intercourse while taking study drug/s and for 3 months after study drug discontinuation and thus do not attempt to father a child in this period.
Clareo Health | Next Generation Personalized Neuroblastoma Therapy
