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Pilot Study of Zoledronic Acid and Interleukin-2 for Refractory Pediatric Neuroblastoma: Assessment of Tolerability and In Vivo Expansion γδ T-Cells

Phase 1
2 Years
21 Years
Open (Enrolling)

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Trial Information

Pilot Study of Zoledronic Acid and Interleukin-2 for Refractory Pediatric Neuroblastoma: Assessment of Tolerability and In Vivo Expansion γδ T-Cells

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

- 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

- 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

- 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

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Evaluate the safety and toxicity of zoledronic acid and aldesleukin

Outcome Description:

The NCI Common Terminology Criteria for AEs will be used for reporting & identification of dose limiting toxicities. DLTs will include any grade 3 non-hematologic toxicity not included here: Gr 3 nausea & vomiting & diarrhea, Gr 3 fever, Gr 3 skin toxicity that remains stable & tolerable, or improves with treatment within 24 hrs, Gr 3 neurotoxicity with subjective findings, Gr 4 hematologic toxicity, which improves to at least Gr 2 or baseline pre-therapy values within one week of completing IL2 infusion, Gr 3 performance that returns to 50 or higher before the start of the next therapy cycle.

Outcome Time Frame:

1.5 years

Safety Issue:


Principal Investigator

Joseph Pressey, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The University of Alabama at Birmingham


United States: Institutional Review Board

Study ID:

UAB 1051



Start Date:

August 2011

Completion Date:

September 2014

Related Keywords:

  • Neuroblastoma
  • Neuroblastoma
  • Pediatrics
  • Refractory
  • Immunotherapy
  • Biological therapy
  • Lymphocytes
  • Cancer
  • Bisphosphonate
  • Neuroblastoma



University of Alabama at Birmingham-Children's of AlabamaBirmingham, Alabama  35233