Status:
TERMINATED
Pilot Study of Zoledronic Acid and Interleukin-2 for Refractory Pediatric Neuroblastoma
Lead Sponsor:
University of Alabama at Birmingham
Conditions:
Neuroblastoma
Eligibility:
All Genders
2-21 years
Phase:
PHASE1
Brief Summary
Neuroblastoma (NB) is the most common extracranial solid tumor in children, with an annual incidence of 10.5 per million children less than 15 years of age. NB accounts for 15% of childhood cancer dea...
Eligibility Criteria
Inclusion
- All patients must be diagnosed with treatment-refractory neuroblastoma with no known curative treatment options. Tumor histology should be verified at diagnosis or relapse.
- 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 radionuclide angiography.
- No evidence of dyspnea at rest. If PFTs are performed, FEV1/FVC \> 60% by pulmonary function test.
- Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled.
- CNS toxicity \< Grade 2.
Exclusion
- Females of childbearing potential must have a negative pregnancy test.
- Patients of childbearing potential must agree to use an effective birth control method.
- 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 consent.
- All institutional requirements for human studies must be met.
- Previous treatment with anti-GD2 and interleukin2 therapy
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT01404702
Start Date
August 1 2011
End Date
August 1 2014
Last Update
December 2 2014
Active Locations (1)
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1
University of Alabama at Birmingham-Children's of Alabama
Birmingham, Alabama, United States, 35233