Pilot Study of Zoledronic Acid and Interleukin-2 for Refractory Pediatric Neuroblastoma: Assessment of Tolerability and In Vivo Expansion γδ T-Cells
- All patients must be diagnosed with treatment-refractory neuroblastoma with no known
curative treatment options. Tumor histology should be verified at diagnosis or
- Prior to enrollment, a determination of residual disease must be performed
- Patients must have a Lansky or Karnofsky performance scale score of ≥ 50%.
- Patients must have a life expectancy of ≥ 2 months (8 weeks).
- Total absolute neutrophil count (ANC) is at least 750, Hgb≥8 grams/dl, and plts ≥
75K. PRBC transfusions are allowed.
- Patients with bone marrow disease will not evaluable for hematologic toxicity. These
patients must have a peripheral absolute neutrophil count
- 750, platelet count ≥ 50K and Hgb ≥8 grams/dl. Transfusions are permitted to
meet both the platelet and hemoglobin criteria.
- Creatinine clearance or radioisotope GFR > 70mL/min/1.73 m2 or a serum creatinine
based on age/gender as follows:
- ≤ 0.8 mg/dL (for patients 2 to 5 years of age)
- ≤ 1.0 mg/dL (for patients 6 to 9 years of age)
- ≤ 1.2 mg/dL (for patients 10 to 12 years of age)
- ≤ 1.4 mg/dL (for female patients ≥ 13 years of age)
- ≤ 1.5 mg/dL (for male patients 13 to 15 years of age)
- ≤ 1.6 mg/dL (for male patients ≥ 16 years of age)
- Total bilirubin ≤ 2.5 x upper limit of normal (ULN) for age, and
- SGPT (ALT) < 2.5 x upper limit of normal (ULN) for age.
- SOS (sinusoidal obstruction syndrome, formerly known as veno-occlusive disease
[VOD]), if present, should be stable or improving.
- Shortening fraction of > 27% by echocardiogram, or ejection fraction of > 55% by
- No evidence of dyspnea at rest. If PFTs are performed, FEV1/FVC > 60% by pulmonary
- Patients with seizure disorder may be enrolled if on anticonvulsants and well
- CNS toxicity < Grade 2.
- Females of childbearing potential must have a negative pregnancy test.
- Patients of childbearing potential must agree to use an effective birth control
- Female patients who are lactating must agree to stop breast-feeding.
- All patients and/or their parents or legal guardians must sign a written informed
- All institutional requirements for human studies must be met.
- Previous treatment with anti-GD2 and interleukin2 therapy