RECRUITING

Naxitamab Added to Induction for Newly Diagnosed High-Risk Neuroblastoma

Conditions

High-risk Neuroblastoma naxitimab induction

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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. Naxitamab will be added to all 5 Induction cycles. We hypothesize that the addition of anti-GD2 therapy to induction chemotherapy will result in improved end of induction responses and improved survival.

Official Title

A Phase II Study of Naxitamab Added to Induction Therapy for Subjects With Newly Diagnosed High-Risk Neuroblastoma

Quick Facts

Study Start:2022-09-14

Study Completion:2033-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05489887

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Months to 21 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion Criteria
* Diagnosis: Subjects 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 metabolites. Subjects with the following disease stages at diagnosis are eligible, if they meet the other specified criteria: * Subjects must be age ≤ 21 years at initial diagnosis * Subjects must be \>12 months of age at enrollment * Ability to tolerate Peripheral blood stem cell (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 a physical condition that would limit the ability of the child to undergo apheresis catheter placement (if necessary) and/or the apheresis procedure. * Adequate Cardiac Function Defined As: 1. Shortening fraction of ≥ 27% by echocardiogram, or 2. Ejection fraction of ≥ 50% by radionuclide evaluation or echocardiogram. * Adequate liver function must be demonstrated, defined as: 1. Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age AND 2. ALT (SGPT) \< 5 x upper limit of normal (ULN) for age * Subjects must have adequate renal function defined as a serum creatinine based on age/gender as follows: * A negative serum pregnancy test is required for female participants of childbearing potential (≥13 years of age or after onset of menses) * Both male and female post-pubertal study subjects 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 until 6 months after study treatment discontinuation. Such methods include: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner, sexual abstinence. * Informed Consent: All subjects and/or legal guardians must sign informed written consent. Assent, when appropriate, will be obtained according to institutional guidelines.	* Subjects who are less than 1 year of age * Subjects who are 12-18 months of age with INSS Stage 4 and all stage 3 subjects with favorable biologic features (i.e., nonamplified MYCN, favorable pathology, and DNA index \> 1) are not eligible. * Subjects 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 per a low or intermediate risk neuroblastoma regimen (as per P9641, A3961, ANBL0531, or similar) prior to determination of MYCN amplification status and histology. * Treatment with immunosuppressive treatment (local 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 these assessments are clinically indicated. * Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study.) * Subjects receiving any investigational drug concurrently. * Subjects 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 results or which would interfere with a subject's ability to sign or the legal guardian's ability to sign the informed consent, and subject's ability to cooperate and participate in the study. * Subjects 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 action of investigational medicinal products (IMPs) or to significantly increase the severity of the toxicities experienced from trial treatment.

Inclusion Criteria

Exclusion Criteria

* Diagnosis: Subjects 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 metabolites. Subjects with the following disease stages at diagnosis are eligible, if they meet the other specified criteria:
* Subjects must be age ≤ 21 years at initial diagnosis
* Subjects must be \>12 months of age at enrollment
* Ability to tolerate Peripheral blood stem cell (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 a physical condition that would limit the ability of the child to undergo apheresis catheter placement (if necessary) and/or the apheresis procedure.
* Adequate Cardiac Function Defined As:
1. Shortening fraction of ≥ 27% by echocardiogram, or
2. Ejection fraction of ≥ 50% by radionuclide evaluation or echocardiogram.
* Adequate liver function must be demonstrated, defined as:
1. Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age AND
2. ALT (SGPT) \< 5 x upper limit of normal (ULN) for age
* Subjects must have adequate renal function defined as a serum creatinine based on age/gender as follows:
* A negative serum pregnancy test is required for female participants of childbearing potential (≥13 years of age or after onset of menses)
* Both male and female post-pubertal study subjects 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 until 6 months after study treatment discontinuation. Such methods include: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner, sexual abstinence.
* Informed Consent: All subjects and/or legal guardians must sign informed written consent. Assent, when appropriate, will be obtained according to institutional guidelines.

* Subjects who are less than 1 year of age
* Subjects who are 12-18 months of age with INSS Stage 4 and all stage 3 subjects with favorable biologic features (i.e., nonamplified MYCN, favorable pathology, and DNA index \> 1) are not eligible.
* Subjects 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 per a low or intermediate risk neuroblastoma regimen (as per P9641, A3961, ANBL0531, or similar) prior to determination of MYCN amplification status and histology.
* Treatment with immunosuppressive treatment (local 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 these assessments are clinically indicated.
* Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study.)
* Subjects receiving any investigational drug concurrently.
* Subjects 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 results or which would interfere with a subject's ability to sign or the legal guardian's ability to sign the informed consent, and subject's ability to cooperate and participate in the study.
* Subjects 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 action of investigational medicinal products (IMPs) or to significantly increase the severity of the toxicities experienced from trial treatment.

Contacts and Locations

Study Contact

BCC Enroll

CONTACT

7175310003

BCCEnroll@pennstatehealth.psu.edu

Principal Investigator

Jaqueline Kraveka, DO

STUDY_CHAIR

Medical University of South Carolina

Study Locations (Sites)

University of Alabama, Children's Alabama

Birmingham, Alabama, 35201

United States

Arkansas Children's Hospital

Little Rock, Arkansas, 72202

United States

UCSF Benioff Children's Hospital Oakland-

Oakland, California, 94609

United States

Augusta University Health

Augusta, Georgia, 30912

United States

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, 96813

United States

Levine Children's Hospital

Charlotte, North Carolina, 28204

United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157

United States

Dell Children's Blood and Cancer Center

Austin, Texas, 78723

United States

Collaborators and Investigators

Sponsor: Giselle Sholler

Jaqueline Kraveka, DO, STUDY_CHAIR, Medical University of South Carolina

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-14

Study Completion Date2033-09

Study Record Updates

Study Start Date2022-09-14

Study Completion Date2033-09

Terms related to this study

Keywords Provided by Researchers

naxitimab
induction

Additional Relevant MeSH Terms

High-risk Neuroblastoma