A Study of N9 Chemotherapy in Children With Neuroblastoma

• Status: Recruiting
• Trial end date: 2022-06-22
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Treatments: Carboplatin; Cyclophosphamide; Doxorubicin; Etoposide; Ifosfamide; Topotecan; Vincristine

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.