BridgeMD
New treatment option for Neuroblastoma
Official title Pediatric Precision Laboratory Advanced Neuroblastoma Therapy
ClinicalTrials.gov ID: NCT02559778
What this study is testing
What is Ceritinib?
Ceritinib is an investigational medicine, being studied as a potential treatment for neuroblastoma.
Also referred to as Zykadia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A prospective open label, multicenter study to evaluate the feasibility and acute toxicity of using molecularly guided therapy in combination with standard therapy followed by a Randomized Controlled Trial of standard immunotherapy with or without DFMO followed by DFMO maintenance for Subjects with Newly Diagnosed High-Risk Neuroblastoma.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 22
You may be able to join if
- Part A- CLOSED:
- Diagnosis: people must have a diagnosis of neuroblastoma or ganglioneuroblastoma (nodular or intermixed) verified by histology or demonstration of...
- people must be age ≤ 21 years at initial diagnosis
- people must not have had prior systemic therapy except for localized emergency radiation to sites of life-threatening or function-threatening disease...
- Specimens will be obtained only in a non-significant risk manner and not solely for the purpose of investigational testing.
You likely can't join if
- (Part A and B)
- people who are 12-18 months of age with INSS Stage 4 and all stage 3 people with favorable biologic features (ie, nonamplified MYCN, favorable...
- Lactating females are not eligible unless they have agreed not to breastfeed their infants.
- people receiving any investigational drug concurrently.
- people with any other medical condition, including but not limited to malabsorption syndromes, mental illness or substance abuse, deemed by the...
See the full eligibility criteria
- Part A- CLOSED:
- Diagnosis: people must have a diagnosis of neuroblastoma or ganglioneuroblastoma (nodular or intermixed) verified by histology or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamine...
- people must be age ≤ 21 years at initial diagnosis
- people must not have had prior systemic therapy except for localized emergency radiation to sites of life-threatening or function-threatening disease and/or no more than 1 cycle of chemotherapy per a low or intermediate...
- Specimens will be obtained only in a non-significant risk manner and not solely for the purpose of investigational testing.
- Ability to tolerate PBSC collection: No known contraindication to PBSC collection. Examples of contraindications would include a weight or size less than that determined to be feasible at the collecting institution, or...
- Adequate Cardiac Function Defined As:
- Shortening fraction of ≥ 27% by echocardiogram, or
- Ejection fraction of ≥ 50% by radionuclide evaluation or echocardiogram.
- Adequate liver function must be demonstrated, defined as: c. Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age AND d. ALT (SGPT) \< 10 x upper limit of normal (ULN) for age
- people must have adequate renal function defined as a serum creatinine based on age/gender as follows: Age Maximum Serum Creatinine (mg/dL) Male Female 1 month to \< 6 months 0.4 0.4 6 months to \< 1 year 0.5 0.5 1 to...
- 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 people 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...
- Informed Consent: All people and/or legal guardians must sign informed written consent. Assent, when appropriate, will be obtained according to institutional guidelines. Part B- OPEN:
- All patients must have a pathologically confirmed diagnosis of neuroblastoma, be age ≤ 21 years at initial diagnosis, and classified as high risk by the criteria used by COG or SIOPEN at the time of diagnosis...
- Previous Therapy- people must fit into one of the strata categories listed in section 10.5 to be eligible to enroll on Part B of this study.
- Pre-enrollment tumor survey: Prior to enrollment on Part B, a determination of mandatory disease staging must be performed. Tumor imaging studies including CT or MRI, MIBG or PET, and VMA/HVA (PET scan should be done...
- Timing- Enrollment to occur prior to Day + 120 post-transplant, preferably when the subject is within 28 days after completing local radiation therapy (if given).
- (Part A and B)
- people who are 12-18 months of age with INSS Stage 4 and all stage 3 people with favorable biologic features (ie, nonamplified MYCN, favorable pathology, and DNA index \> 1) are not eligible.
- Lactating females are not eligible unless they have agreed not to breastfeed their infants.
- people receiving any investigational drug concurrently.
- people with any other medical condition, including but not limited to malabsorption syndromes, mental illness or substance abuse, deemed by the Investigator to be likely to interfere with the interpretation of the...
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Little Rock, Arkansas, United States
- Oakland, California, United States
- San Diego, California, United States
- Hartford, Connecticut, United States
- Miami, Florida, United States
- Orlando, Florida, United States
- Tampa, Florida, United States
- Augusta, Georgia, United States
- Honolulu, Hawaii, United States
- Boise, Idaho, United States
- Chicago, Illinois, United States
- Louisville, Kentucky, United States
- Grand Rapids, Michigan, United States
- Minneapolis, Minnesota, United States
- Kansas City, Missouri, United States
- St Louis, Missouri, United States
- Hackensack, New Jersey, United States
- Charlotte, North Carolina, United States
- Portland, Oregon, United States
+ 8 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 22 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Little Rock, Arkansas, United States; Oakland, California, United States; San Diego, California, United States; Hartford, Connecticut, United States; Miami, Florida, United States and 22 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.