Molecular Guided Therapy for Refractory or Recurrent Neuroblastoma
Molecular Guided Therapy for Refractory or Recurrent Neuroblastoma
The purpose of this study is to test the feasibility (ability to be done) of an experimental
 test to help plan your cancer treatment. This study plan is not studying the effectiveness of
 the proposed combinations of therapy for your cancer that you may receive after the
 experimental testing.

 This study will look at an experimental technology to determine a tumor's molecular makeup
 (gene expression profile). This technology (called "OncInsights") is being used to discover
 new ways to understand cancers and potentially predict the best treatments for patients with
 cancer in the future. The experimental technology has not been approved by the U.S. Food and
 Drug Administration.
Inclusion Criteria:

 -  Patients must have histologically proven neuroblastoma and confirmation of refractory
 or recurrent disease with histologic confirmation at diagnosis or at the time of
 recurrence/progression

 -  Patients must be age > 12 months and ≤ 21 at initial diagnosis.

 -  Life expectancy must be more than 3 months

 -  If measurable disease, this must be demonstrated by residual abnormal tissue at a
 primary or metastatic site measuring more than 1 cm in any dimension by standardized
 imaging (CT or MRI); tumor must be accessible for biopsy. Patients with bone marrow
 only disease expected to be > 75% are eligible to enroll.

 -  Current disease state must be one for which there is currently no known curative
 therapy

 -  Lansky or KarnofskyScore must be more than 50

 -  Patients without bone marrow metastases must have an ANC > 750/μl and platelet count >
 50,000/μl

 -  Adequate liver function must be demonstrated, defined as:

 -  Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age AND

 -  SGPT (ALT) < 10 x upper limit of normal (ULN) for age

 -  No other significant organ toxicity defined as > Grade 2 by National Cancer Institute
 Common Toxicity Criteria for Adverse Events NCI-CTCAE V4.0

 -  A negative serum pregnancy test is required for female participants of child bearing
 potential (≥ 13 years of age or after onset of menses)

 -  Both male and female post-pubertal study subjects need to agree to use one of the more
 effective birth control methods during treatment and for six months after treatment is
 stopped. These methods include total abstinence (no sex), oral contraceptives ("the
 pill"), an intrauterine device (IUD), levonorgestrol implants (Norplant), or
 medroxyprogesterone acetate injections (Depo-provera shots). If one of these cannot be
 used, contraceptive foam with a condom is recommended.

 -  Informed Consent: All patients and/or legal guardians must sign informed written
 consent. Assent, when appropriate, will be obtained according to institutional
 guidelines. Voluntary consent for optional biology studies will be included.

 Exclusion Criteria:

 -  Patients who have received any chemotherapy within the last 7 days prior to enrollment
 and 14 days prior to study treatment start date.

 -  Patients who have received any radiotherapy within the last 30 days must have another
 site of disease to follow.

 -  Patients receiving anti-tumor therapy for their disease or any investigational drug
 concurrently

 -  Patients with serious infection or a life-threatening illness (unrelated to tumor)
 that is > Grade 2 (NCI CTCAE V4.0), or active, serious infections requiring parenteral
 antibiotic therapy.

 -  Patients with any other medical condition, including malabsorption syndromes, mental
 illness or substance abuse, deemed by the Investigator to be likely to interfere with
 the interpretation of the results or which would interfere with a patient's ability to
 sign or the legal guardian's ability to sign the informed consent, and patient's
 ability to cooperate and participate in the study