Study: NANT 2014-01
SF1126 for patients with Relapsed or Refractory Neuroblastoma
Protocol Title: Phase I Study of SF1126 in Patients with Relapsed or Refractory Neuroblastoma
Study Chair: Steven Dubois, MD. (Dana Farber Cancer Institute)
What is this study about:
This study involves the use of an experimental drug called SF1126 that has not been approved by the United States Food and Drug Administration (FDA). SF1126 blocks the function of proteins that are important in the growth of cancer cells and seems to affect Mycn, a protein important in neuroblastoma growth.
SF1126 is considered experimental because it has not been proven to work in a situation like yours. SF1126 has been used in only a small number of adults so there is a lot we do not know about it yet. SF1126 has not previously been used in children.
This study is called a phase I study because the goal is to find the highest dose of SF1126 that we can give safely. Once we have found out the highest dose of SF1126 that can be given safely, we will treat more neuroblastoma patients with this dose of SF1126 who are known to have changes of certain proteins called Myc and Mycn.
Why is this study being done:
Criteria that need to be met to participate in this study
1) Relapsed or progressive disease at any time before study enrollment.
2) Refractory disease: patients had "no response" and still have persistent sites of disease after receiving a minimum of 4 cycles of induction treatment and have never had a disease relapse or progression.
3) Persistent disease: patients had a "partial response" and still have persistent sites of disease after receiving a minimum of 4 cycles of induction treatment and have never had a disease relapse or progression.
Some patients will need a surgical biopsy done of the tumor to confirm it is neuroblastoma before they will be able to enroll on study. Please check with your doctor as they will be able to tell you if your child will need a biopsy to meet the requirements to enroll on this study.
Patients cannot participate in the study if:
This study will test up to 3 SF1126 doses in groups of 3-6 patients, which will be assigned upon enrollment.
Each treatment course is 28 days.
This diagram outlines one course of therapy on this study:
Patients will have their neuroblastoma evaluated by bone marrow tests and scans after day 1 of week 4 of treatment of cycles 2, 4 and 6. Each cycle is 28 days.
Patients may receive up to 6 cycles of therapy (6 months) on study in the absence of progressive disease. Decisions regarding additional therapy on this study will be made by the study chair and treating physician in collaboration with the NANT Medical Director.