A Study of N9 Chemotherapy in Children With Neuroblastoma

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase

Active, not recruiting

Early Phase 1

Conditions

Neuroblastoma

Pediatric Cancer

Treatments

Drug: Carboplatin

Drug: Etoposide

Drug: Doxorubicin

Drug: Ifosfamide

Drug: Topotecan

Drug: Mesna

Drug: Cyclophosphamide

Drug: Vincristine

Study type

Interventional

Funder types

Other

Identifiers

NCT04947501

21-228

Details and patient eligibility

About

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).

Enrollment

26 patients

Sex

All

Ages

1 to 19 years old

Volunteers

No Healthy Volunteers

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 stage 4 in patients >18 months old.
No more than one prior cycle of chemotherapy.
Age <19 years old.
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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

26 participants in 1 patient group

Participants with newly-diagnosed HR-Neuroblastoma

Experimental group

Description:

This pilot study of N9 as induction chemotherapy will enroll 30 patients with newly-diagnosed HR-NB. A first cohort of \>1 to 12-year old, and a second cohort of extended age \<19 years old. Both cohorts will be analyzed together.

Treatment: