Phase 3
N=105
Monoclonal Antibody Ch14.18, Sargramostim, Aldesleukin, and Isotretinoin After Autologous Stem Cell Transplant in Treating Patients With Neuroblastoma
High Risk Neuroblastoma
Bottom Line
View on ClinicalTrials.gov: NCT01041638 ↗Enrolled (actual)
105
Serious AEs
99.0%
Results posted
Feb 2015
Primary outcome: Primary: Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). — 17.3077; 5.0000; 6.1224; 4.4444 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Aldesleukin (Biological); Diagnostic Laboratory Biomarker Analysis (Other); Dinutuximab (Biological); Isotretinoin (Drug); Sargramostim (Biological)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). |
17.3077; 5.0000; 6.1224; 4.4444; 5.6818; 0.00000 | — |
| SECONDARY Event-free Survival (EFS) |
67.6 | — |
| SECONDARY Overall Survival (OS) |
79.1 | — |
Summary
This phase III trial is studying the side effects of giving monoclonal antibody Ch14.18 together with sargramostim, aldesleukin, and isotretinoin after autologous stem cell transplant in treating patients with neuroblastoma. Monoclonal antibodies, such as Ch14.18, may find tumor cells and help kill them. Colony-stimulating factors, such as sargramostim, may increase the number of immune cells found in bone marrow or peripheral blood. Aldesleukin may stimulate the white blood cells to kill tumor cells. Isotretinoin may help neuroblastoma cells become more like normal cells, and to grow and spread more slowly. Giving monoclonal antibody Ch14.18 with sargramostim, aldesleukin, and isotretinoin after autologous stem cell transplant may be an effective treatment for neuroblastoma.
Eligibility Criteria
Inclusion Criteria
- All patients must be diagnosed with neuroblastoma, and categorized as high-risk at the time of diagnosis
- At pre-ASCT evaluation, patients must meet the International Neuroblastoma Response Criteria (INRC) for complete response (CR), very good partial response (VGPR), or partial response (PR) for primary site, soft tissue metastases and bone metastases; patients who meet those criteria must also meet the protocol specified criteria for bone marrow response as outlined below: = 16 years of age and Lansky for patients = = 50%
- Patients must have a life expectancy of >= 2 months (8 weeks)
- Total absolute phagocyte count (APC = neutrophils + monocytes) is at least 1000/uL
- Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or a serum creatinine based on age/gender as follows:
- 1 month to = 16 years: 1.7 mg/dL (male), 1.4 mg/dL (female)
- Total bilirubin = = 27% by echocardiogram, or ejection fraction of >= 55% by radionuclide angiography
- No evidence of dyspnea at rest
- If pulmonary function tests (PFTs) are performed, forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) > 60% by pulmonary function test
- Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled
- Central nervous system (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 method
- Female patients who are lactating must agree to stop breast-feeding
- Patients must not have received prior anti-GD2 antibody therapy
- Patients must not have received prior vaccine therapy administered as treatment of neuroblastoma not routine infectious disease vaccinations
Data sourced from ClinicalTrials.gov (NCT01041638). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.