Clinical trial · Interventional
Monoclonal Antibody Therapy With Sargramostim and Interleukin-2 in Treating Children With Neuroblastoma
A PHASE I STUDY OF CHIMERIC HUMAN/MURINE ANTI-GD2 MONOCLONAL ANTIBODY (ch14.18) WITH GM-CSF AND INTERLEUKIN-2 (IL-2) IN CHILDREN WITH NEUROBLASTOMA IMMEDIATELY POST AUTOLOGOUS BMT OR PBSC RESCUE
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Disseminated Neuroblastoma | — | UNRESOLVED | — |
| Recurrent Neuroblastoma | Neuroblastoma | CURATED_BROADER | 0.78 |
| Regional Neuroblastoma | Regional Neuroblastoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| aldesleukin | Biological | Aldesleukin | ALIAS |
| isotretinoin | Drug | — | UNRESOLVED |
| monoclonal antibody Ch14.18 | Biological | — | UNRESOLVED |
| sargramostim | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (monoclonal antibody Ch14.18, aldesleukin)
- description
- Patients receive MOAB IV over 5 hours on days 7-10 during courses 2 and 4 and on days 3-6 during courses 1, 3, and 5; sargramostim (GM-CSF) IV over 2 hours or subcutaneously daily on days 0-13 during courses 1, 3, and 5; interleukin-2 IV continuously on days 0-3 and 7-10 during courses 2 and 4; and oral isotretinoin twice daily on days 14-27 during courses 2 and 4 and on days 10-23 during courses 3 and 5. Treatment repeats every 24-32 days for 5 courses in the absence of unacceptable toxicity.
- interventionNames
- Biological: monoclonal antibody Ch14.18
- Drug: isotretinoin
- Biological: aldesleukin
- Biological: sargramostim
Primary outcomes (1)
- measure
- Maximum tolerated dose of monoclonal antibody (MOAB) ch14.18 when combined with sargramostim and IL-2 after autologous bone marrow or peripheral blood stem cell rescue in children with neuroblastoma
- timeFrame
- 32 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 21 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available