Monoclonal Antibody Therapy With Sargramostim and Interleukin-2 in Treating Children With Neuroblastoma

Completed · Phase 1

Conditions studied: Disseminated Neuroblastoma, Recurrent Neuroblastoma, Regional Neuroblastoma

In brief

Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood. Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. Combining monoclonal antibody therapy with sargramostim or interleukin-2 may kill more tumor cells. Phase I trial to study the effectiveness of monoclonal antibody therapy given with sargramostim and interleukin-2 in treating children with neuroblastoma who have just completed bone marrow or peripheral stem cell transplantation

Key facts

Study ID: NCT00005576
Run by: National Cancer Institute (NCI)
People needed: 6
Starts: 2001-01-01
Last updated by the study team: 2013-01-16

Who can join

Age: any, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Must have recently completed a course of myeloablative therapy followed by autologous stem cell (bone marrow or peripheral blood) rescue (ASCT)
Patients must have a diagnosis of neuroblastoma based upon tumor histology or bone marrow metastases and elevated urine catecholamine metabolites; greater than 98% of neuroblastomas are GD2-positive without intratumor heterogeneity, so these tumors will not be immunostained prior to study entry
Patients entered on CCG-3951 may become eligible following the third course of high-dose chemotherapy followed by peripheral blood stem cell (PBSC) rescue; patients treated on institutional (local) protocols of high-dose chemotherapy with PBSC rescue may also become eligible after one or more courses of PBSC rescue
Patients must enter onto study within 8 weeks after the total absolute phagocyte count [neutrophils (segs + bands) + monocytes] is > 1,000/uL; the APC criteria include counts obtained while on G-CSF therapy
Patients must have a performance status of 0, 1 or 2 and patients must have a life expectancy of >= 2 months
Serum creatinine =< 1.5 x normal, or creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 60 ml/min/1.73 m\^2
Total bilirubin =< 1.5 x normal
Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 5 x normal
Veno-occlusive disease, if present, should be stable or improving
Shortening fraction of >= 27% by echocardiogram, or ejection fraction of > 50% by gated radionuclide study
Forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) > 60% of predicted by pulmonary function test
For children who are unable to do pulmonary function tests (PFTs), no evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry > 94% on room air
Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled
Central nervous system (CNS) toxicity < grade 2
Patients must have a double lumen catheter or single lumen and peripheral IV so that interleukin (IL)-2 and ch14.18 can be given separately
Patients who remain evaluable for response on Phase II/III studies (i.e. CCG-3891) are not eligible for this study; however, patients treated on Phase I studies (i.e. CCG-3951) and patients who are no longer evaluable on Phase II/III studies (i.e. progressive disease following therapy) will be eligible
Patients who were previously treated with antibody 14.G2a or ch14.18 are ineligible for this study
Patients requiring chronic use of corticosteroids are ineligible
Corticosteroid, immunosuppressive drugs, myelosuppressive chemotherapy, and retinoic acid must not be given within 14 days prior to study entry
Radiation therapy must not be given within seven days prior to study entry or during therapy
All patients and/or their parents or legal guardians must sign a written informed consent
All institutional, FDA, and NCI requirements for human studies must be met

Where it is running

Children's Oncology Group — Arcadia, California, United States

Full record on ClinicalTrials.gov

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