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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Aldesleukin; Antibodies; Antibodies, Monoclonal; Dinutuximab; Immunoglobulins; Interleukin-2; Isotretinoin; Sargramostim

Criteria

Inclusion Criteria:

• 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