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"This study is not industry-sponsored but rather investigator-initiated, which introduced layers of complexity with respect to processes and procedures. NANT 07-02 officially opened for patient enrollment on Thursday, December 17, 2009 and the first patient was enrolled January 14, 2010! Great news!!!"
”The trial was opened December 16, 2009 and accrued patients very rapidly. A total of 6 patients were entered between January and April 2010 from 5 different participating NANT (New Approaches to Neuroblastoma Therapy) sites. The study was then suspended to patient entry for a planned data review of the first 6 patients. Based on this review, the protocol was amended and is currently open to patient accrual, with slightly stricter liver function eligibility requirements.”
”The N07-02 trial has recently completed accrual, with the last patient enrolling on September 3, 2013. A total of 27 patients were enrolled from 11 different participating NANT (New Approaches to Neuroblastoma Therapy) sites. Patients received a median of 2, with a range of 1-16 courses, each lasting 28 days. There were very few severe side effects or hospitalizations. The study successfully determined the doses of intravenous and oral cyclophosphamide that could be given safely and tolerably with Zometa and Avastin in this regimen designed to target new tumor blood vessel growth and the bone microenvironment. We are now analyzing the correlative study specimens collected during the first two courses to determine whether we can predict the patients most likely to benefit from this kind of therapy. We also hope to learn more about the effects Avastin and Zometa have on normal cells and blood factors which affect the growth of tumors, especially in metastatic bone sites. Preliminary results from this study were presented in Toronto, Canada at the 2012 Advances in Neuroblastoma Research meeting.”
"The N0702 Clinical Trial was officially activated on December 9, 2008 at NANT. Although they still need to do some investigator training and get the protocol approved at each of their institutions, they are well on their way and hopeful that they will begin to enroll patients in early 2009." Great news!!!
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