BridgeMD
New treatment option for Neuroblastoma
Official title Naxitamab Added to Induction for Newly Diagnosed High-Risk Neuroblastoma
ClinicalTrials.gov ID: NCT05489887
What this study is testing
What is Naxitamab?
Naxitamab is an investigational medicine, being studied as a potential treatment for neuroblastoma.
Also referred to as Danyelza.
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
- This is a prospective, multicenter clinical trial in subjects with newly diagnosed high-risk neuroblastoma to evaluate the efficacy and safety of administering naxitamab with standard induction therapy. The initial chemotherapy will include 5 cycles of multi-agent chemotherapy.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 21
You may be able to join if
- Diagnosis: people must have a diagnosis of neuroblastoma or ganglioneuroblastoma (nodular or intermixed) verified by histology or demonstration of...
- people with newly diagnosed neuroblastoma with INRGSS Stage M disease with either of the following features:
- MYCN amplification (\> 4-fold increase in MYCN signals as compared to reference signals), regardless of additional biologic features; OR
- 365 days to ≥ 547 days of age without MYCN amplification, but unfavorable biologic features such as unfavorable histology (INPC) or diploid tumor...
- Age \> 547 days of age regardless of biologic features people with newly diagnosed neuroblastoma with INRGSS Stage MS disease with either of the...
You likely can't join if
- people who are less than 1 year of age
- people who are 12-18 months of age with INRGSS Stage M and all stage L2 people with favorable biologic features (i.e., nonamplified MYCN, favorable...
- people who have had prior systemic therapy except for localized emergency radiation to sites of life-threatening or function-threatening disease...
- Treatment with immunosuppressive treatment (topical, inhaled and short-term emergency steroids excluded) within 4 weeks prior to enrollment
- Inadequate pulmonary function defined as evidence of dyspnea at rest, exercise intolerance, and/or chronic oxygen requirement. In addition, room air...
- Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study.)
See the full eligibility criteria
Who can join
- 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 with newly diagnosed neuroblastoma with INRGSS Stage M disease with either of the following features:
- MYCN amplification (\> 4-fold increase in MYCN signals as compared to reference signals), regardless of additional biologic features; OR
- 365 days to ≥ 547 days of age without MYCN amplification, but unfavorable biologic features such as unfavorable histology (INPC) or diploid tumor (DNA index=1) or the presence of any segmental chromosome aberration...
- Age \> 547 days of age regardless of biologic features people with newly diagnosed neuroblastoma with INRGSS Stage MS disease with either of the following:
- MYCN amplification (\> 4-fold increase in MYCN signals as compared to reference signals); OR
- 365 days to ≥ 547 days (18 months) of age without MYCN amplification, but unfavorable biologic features such as unfavorable histology (INPC) or diploid tumor (DNA index=1) or SCA as above people with newly diagnosed...
- MYCN amplification (\> 4-fold increase in MYCN signals as compared to reference signals); OR
- 18 months to \<5 years of age without MYCN amplification, but with unfavorable histology (INPC); OR
- ≥5 years of age without MYCN amplification, but with undifferentiated or poorly differentiated INPC people with newly diagnosed neuroblastoma INRGSS Stage L1 disease that is incompletely resected with MYCN...
- people must be age ≤ 21 years at initial diagnosis.
- people must be \>12 months of age at enrollment.
- 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:
- Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age AND
- ALT (SGPT) \< 5 x upper limit of normal (ULN) for age
- 1\. people must have adequate renal function defined as:
- For people \< 17 years old: estimated Glomerular Filtration rate (eGFR) as calculated from the Bedside Schwartz equation (in units of mL/min/1.73 m2) or via radioisotope GFR of ≥ 70 mL/min/1.73 m2. The Bedside Schwartz...
- For people ≥17 years old: estimated Glomerular Filtration rate (eGFR) as calculated from the Cockcroft and Gault formula (in units of mL/min/1.73 m2) or via radioisotope GFR of ≥ 70 mL/min/1.73 m2. The Cockcroft and...
- OR a 24 hour urine Creatinine clearance ≥ 70 mL/min/1.73 m2
- A negative serum pregnancy test is required for people of childbearing potential (≥13 years of age or after onset of menses)
- Both male and female post-pubertal study people must be willing to use a highly effective contraceptive method (i.e., achieves a failure rate of \<1% per year when used consistently and correctly) from the time of...
- Informed Consent: All people and/or legal guardians must sign informed written consent. Assent, when appropriate, will be obtained according to institutional guidelines and applicable local regulations.
What rules you out
- people who are less than 1 year of age
- people who are 12-18 months of age with INRGSS Stage M and all stage L2 people with favorable biologic features (i.e., nonamplified MYCN, favorable pathology, and DNA index \> 1) are not eligible.
- people who 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.
- Treatment with immunosuppressive treatment (topical, inhaled and short-term emergency steroids excluded) within 4 weeks prior to enrollment
- Inadequate pulmonary function defined as evidence of dyspnea at rest, exercise intolerance, and/or chronic oxygen requirement. In addition, room air pulse oximetry \< 94% and/or abnormal pulmonary function tests if...
- Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study.)
- 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...
- people with a significant intercurrent illness (any ongoing serious medical problem unrelated to cancer or its treatment) that is not covered by the detailed exclusion criteria and that is expected to interfere with 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
- Gainesville, Florida, United States
- Miami, Florida, United States
- Orlando, Florida, United States
- Augusta, Georgia, United States
- Honolulu, Hawaii, United States
- Louisville, Kentucky, United States
- Minneapolis, Minnesota, United States
- St Louis, Missouri, United States
- Charlotte, North Carolina, United States
- Winston-Salem, North Carolina, United States
- Portland, Oregon, United States
- Hershey, Pennsylvania, United States
- Charleston, South Carolina, United States
- Austin, Texas, United States
- Richmond, Virginia, United States
+ 5 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, 12 months to 21 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; Gainesville, Florida, United States and 19 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.