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
3 other identifiers
interventional
6
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 2, 2000
CompletedStudy Start
First participant enrolled
January 1, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2002
CompletedFirst Posted
Study publicly available on registry
November 5, 2003
CompletedJanuary 16, 2013
January 1, 2013
1.2 years
May 2, 2000
January 15, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
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
32 days
Study Arms (1)
Treatment (monoclonal antibody Ch14.18, aldesleukin)
EXPERIMENTALPatients 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.
Interventions
Given IV
Given orally
Given IV
Given IV
Eligibility Criteria
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
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's Oncology Group
Arcadia, California, 91006-3776, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew Gilman
Children's Oncology Group
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 2, 2000
First Posted
November 5, 2003
Study Start
January 1, 2001
Primary Completion
March 1, 2002
Last Updated
January 16, 2013
Record last verified: 2013-01