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Trial Title:
Clinical Analysis of Naxitamab (hu3F8) in the Treatment of Pediatric High Risk or Refractory/ Relapsed Neuroblastoma
NCT ID:
NCT06013618
Condition:
Neuroblastoma
Conditions: Official terms:
Neuroblastoma
Irinotecan
Topoisomerase I Inhibitors
Temozolomide
Molgramostim
Sargramostim
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Naxitamab monotherapy
Description:
Naxitamab is administered on days 1, 3, and 5
Arm group label:
naxitamab and GM-CSF only
Other name:
hu3F8
Intervention type:
Drug
Intervention name:
GM-CSF
Description:
Each treatment cycle is 28 days and is started with five days (days -4 to 0) of GM-CSF
administered at 250 mcg/m2/day in advance of the start of naxitamab infusion. GM-CSF is
thereafter administered at 500 mcg/m2/day on days 1 to 5.
Arm group label:
naxitamab and GM-CSF only
Other name:
Recombinant Human Granulocyte/Macrophage Colony-stimulating Factor
Intervention type:
Drug
Intervention name:
Irinotecan
Description:
Each HITS treatment cycle is 21 days. Irinotecan intravenously (IV) at 50 mg/m2/day will
be administered from Day 1-5 concurrently with temozolomide orally at 150 mg/m2/day or
100 mg/m2/day.
Arm group label:
naxitamab and GM-CSF in combination with irinotecan and temozolomide
Arm group label:
naxitamab and GM-CSF in combination with irinotecan and temozolomide and PD-1 antibody
Other name:
DNA topoisomerase I inhibitor
Intervention type:
Drug
Intervention name:
Temozolomide
Description:
Each HITS treatment cycle is 21 days. Irinotecan intravenously (IV) at 50 mg/m2/day will
be administered from Day 1-5 concurrently with temozolomide orally at 150 mg/m2/day or
100 mg/m2/day.
Arm group label:
naxitamab and GM-CSF in combination with irinotecan and temozolomide
Arm group label:
naxitamab and GM-CSF in combination with irinotecan and temozolomide and PD-1 antibody
Other name:
Temozolomide for Injection
Intervention type:
Drug
Intervention name:
Naxitamab in combination therapy
Description:
Naxitamab 2.25mg/kg IV will be administered on Days 2, 4, 8 and 10.
Arm group label:
naxitamab and GM-CSF in combination with irinotecan and temozolomide
Arm group label:
naxitamab and GM-CSF in combination with irinotecan and temozolomide and PD-1 antibody
Other name:
hu3F8
Intervention type:
Drug
Intervention name:
GM-CSF with combination regimen
Description:
GM-CSF 250 mcg/m2/day will be administered subcutaneously on Days 6-10.
Arm group label:
naxitamab and GM-CSF in combination with irinotecan and temozolomide
Arm group label:
naxitamab and GM-CSF in combination with irinotecan and temozolomide and PD-1 antibody
Other name:
Recombinant Human Granulocyte/Macrophage Colony-stimulating Factor
Intervention type:
Drug
Intervention name:
Sintilimab
Description:
Sintilimab was administerd with 3mg/kg (max 200mg) on day 11 every 3 weeks.
Arm group label:
naxitamab and GM-CSF in combination with irinotecan and temozolomide and PD-1 antibody
Other name:
PD-1 antibody
Summary:
This is an prospective study to evaluate the safety and efficacy of naxitamab monotherapy
or combined with chemotherapy or combined with chemotherapy and checkpoint inhibitor in
the treatment of pediatric high-risk and refractory/relapsed neuroblastoma in Sun Yat-sen
University Cancer Center.
Detailed description:
Patients with high risk neuroblastoma who obtain CR after chemotherapy combined with
surgery, radiotherapy and/or hematopoietic stem cell transplantation received axitamab
and GM-CSF. Patients with high-risk neuroblastoma treated by chemotherapy combined with
surgery, radiotherapy and or hematopoietic stem cell transplantation patients with tumor
residual or progression during treatment (refractory) received naxitamab and GM-CSF in
combination with irinotecan and temozolomide or naxitamab and GM-CSF in combination with
irinotecan and temozolomide and PD-1 antibody.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1)Confirmed diagnosis of high-risk NB 2)1 year of age or above 3)Patient or
parent/guardian must provide written informed consent to participate 4)If patient is
sexually active, the patient agrees to use effective contraception 5)Confirmed negative
urine pregnancy test for sexually active female of child-bearing potential
(post-menarche)
Exclusion Criteria:
1. Significant organ toxicity
2. Known or suspected allergy or hypersensitivity to anti-GD2 antibodies or to GM-CSF
or its s components.
3. Patient is pregnant, planning to become pregnant (while being treated with
naxitamab) or is currently breastfeeding
4. Patient will undergo treatment with another investigational drug, whilst being
treated with naxitamab or has received another investigational drug within the 4
weeks prior to commencing treatment with naxitamab
5. Patient is either eligible and able to participate in or is currently participating
in an active interventional Y-mAbs sponsored clinical trial with naxitamab within
the indication applied for
6. Patient is unable to comply with the naxitamab treatment or has a medical condition
that would potentially increase the severity of the toxicities experienced from
naxitamab treatment at the discretion of the treating physician
7. Left ventricular ejection fraction of <50% by echocardiography OR other clinically
relevant cardiac disorders at the discretion of the investigator
8. 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
Applicable for treatment with naxitamab in combination with GM-CSF only:
9. Patient has active progression of the NB disease
10. Patient has active NB disease at primary site or soft-tissue metastasis
11. Patient has known CNS metastases when initiating naxitamab treatment
Gender:
All
Minimum age:
12 Months
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
Yi-Zhuo Zhang, MD
Phone:
87342460
Email:
zhangyzh@sysucc.org.cn
Investigator:
Last name:
Yi-Zhuo Zhang, MD
Email:
Principal Investigator
Start date:
June 19, 2023
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Collaborator:
Agency:
Hainan General Hospital
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06013618
