Description:
The purpose of the study is to find out whether N9 is a safe and effective treatment for
children with neuroblastoma. N9 includes 3 different combinations of chemotherapy drugs that
are given at different times - Cyclophosphamide, topotecan, and vincristine (CTV),
Ifosfamide, carboplatin, and etoposide (ICE), Cyclophosphamide, doxorubicin, and vincristine
(CDV).
Title
- Brief Title: A Study of N9 Chemotherapy in Children With Neuroblastoma
- Official Title: N9: Pilot Study of Novel Shortened Induction Chemotherapy for High-Risk Neuroblastoma
Clinical Trial IDs
- ORG STUDY ID:
21-228
- NCT ID:
NCT04947501
Conditions
- Neuroblastoma
- Pediatric Cancer
Interventions
Drug | Synonyms | Arms |
---|
Cyclophosphamide | Cytoxan | Participants with newly-diagnosed HR-Neuroblastoma |
Topotecan | Hycamtin | Participants with newly-diagnosed HR-Neuroblastoma |
Vincristine | Oncovin | Participants with newly-diagnosed HR-Neuroblastoma |
Doxorubicin | Adriamycin | Participants with newly-diagnosed HR-Neuroblastoma |
Ifosfamide | Isophosphamide | Participants with newly-diagnosed HR-Neuroblastoma |
Etoposide | VePesid, Etopophos | Participants with newly-diagnosed HR-Neuroblastoma |
Carboplatin | Paraplatin | Participants with newly-diagnosed HR-Neuroblastoma |
Mesna | Mesnex | Participants with newly-diagnosed HR-Neuroblastoma |
Purpose
The purpose of the study is to find out whether N9 is a safe and effective treatment for
children with neuroblastoma. N9 includes 3 different combinations of chemotherapy drugs that
are given at different times - Cyclophosphamide, topotecan, and vincristine (CTV),
Ifosfamide, carboplatin, and etoposide (ICE), Cyclophosphamide, doxorubicin, and vincristine
(CDV).
Trial Arms
Name | Type | Description | Interventions |
---|
Participants with newly-diagnosed HR-Neuroblastoma | Experimental | This pilot study of N9 as induction chemotherapy will enroll 15 patients with newly-diagnosed HR-NB. | - Cyclophosphamide
- Topotecan
- Vincristine
- Doxorubicin
- Ifosfamide
- Etoposide
- Carboplatin
- Mesna
|
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of NB as defined by histopathology (confirmed by the MSK Department of
Pathology), BM metastases plus high urine catecholamine levels, or positivity in MIBG
scan.
- HR-NB, defined as MYCN-amplified stage 2/3/4/4S at any age and MYCN-nonamplified stage
4 in patients >18 months old.
- No more than one prior cycle of chemotherapy.
- Age >1 year to <13 years old.
- Organ function requirements:
Adequate renal function defined as:
Creatinine clearance or radioisotope GFR ≥ 70 mL/min/1.73 m^2 or A serum creatinine based
on age/sex as follows:
Age: 1 to < 2 years Maximum Serum Creatinine (mg/dL): Male, 0.6; Female, 0.6 Age: 2 to < 6
years Maximum Serum Creatinine (mg/dL): Male, 0.8; Female, 0.8 Age: 6 to ≤ 10 years Maximum
Serum Creatinine (mg/dL): Male, 1; Female, 1
The threshold creatinine values in this Table were derived from the Schwartz formula for
estimating GFR utilizing child length and stature data published by the Centers for Disease
Control.
Adequate liver function defined as:
Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age, and serum alanine
aminotransferase (ALT) < 10 x ULN.
Adequate cardiac function defined as:
Shortening fraction of ≥ 27% by echocardiogram, or Ejection fraction of > 50% by
echocardiogram or radionuclide angiogram.
- Signed informed consent indicating awareness of the investigational nature of this
treatment.
Exclusion Criteria:
- Severe dysfunction of major organs, i.e., renal, cardiac, hepatic, neurologic,
pulmonary, hematologic, or gastrointestinal toxicity ≥ grade 3.
- Inability to comply with protocol requirements.
- Pregnancy is not an issue because all patients will be pre-adolescents.
Maximum Eligible Age: | 13 Years |
Minimum Eligible Age: | 1 Year |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Assess safety of the N9 regimen in participants with HR-NB through toxicity assessment |
Time Frame: | 16 weeks |
Safety Issue: | |
Description: | Adverse events will be graded using Common Toxicity Criteria Version 5.0 developed by the National Cancer Institute of the USA, events of all grades will be tabulated, for non-hematologic effects and hematologic effects on the patients in the safety set. The timing of cycles will also be described to assess any delay due to toxicity |
Details
Phase: | Early Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Memorial Sloan Kettering Cancer Center |
Trial Keywords
- HR-NB
- Neuroblastoma
- pediatric cancer
- 21-228
- Memorial Sloan Cancer Center
Last Updated
August 12, 2021