- Age <1 year old
- 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
- 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)
- Corticosteroids initiated for tumor therapy within 7 days prior to study enrollment
- Other anti-cancer agents
- Other investigational drugs
- 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.
|Maximum Eligible Age:||21 Years|
|Minimum Eligible Age:||1 Year|