Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-25 @ 4:05 AM
NCT ID:
NCT01404702
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
21 Years
Study:
NCT01404702
Study Brief:
Protocol Section:
NCT01404702