High-Dose 3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid for Consolidation of First Remission After Myeloablative Therapy and Autologous Stem-Cell Transplantation
| Status: | Completed |
|---|---|
| Conditions: | Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/3/2018 |
| Start Date: | August 2010 |
| End Date: | October 31, 2018 |
High-Dose 3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid for Consolidation of First Remission After Myeloablative Therapy and Autologous Stem-Cell Transplantation in Patients With High-Risk Neuroblastoma: A Phase II Study
The purpose of this study is to see if high-dose 3F8 combined with GM-CSF is better than
standard dose 3F8 in treating neuroblastoma. Another purpose of the study is to find out what
effects, good and/or bad, 3F8 has on cancer. The investigators also want to see if the
antibody works against a very small amount of neuroblastoma (minimal residual disease) that
is left in the bone marrow.
standard dose 3F8 in treating neuroblastoma. Another purpose of the study is to find out what
effects, good and/or bad, 3F8 has on cancer. The investigators also want to see if the
antibody works against a very small amount of neuroblastoma (minimal residual disease) that
is left in the bone marrow.
Inclusion Criteria:
- Diagnosis of NB as defined by a) histopathology (confirmed by the MSKCC Department of
Pathology), or b) BM metastases or MIBG-avid lesion(s) plus high urine catecholamine
levels.
- High-risk NB as defined by risk-related treatment guidelines1 and the International NB
Staging System,89 i.e., stage 4 with (any age) or without (> or = to 18 months of age)
MYCN amplification, MYCN-amplified stage 2 or stage 3 (any age), or MYCN-amplified
stage 4S.
- The patients are post-stem cell transplantation and in first CR/VGPR, including no
measurable MIBG-avid soft tissue tumor assessable for response.
- Signed informed consent indicating awareness of the investigational nature of this
program.
Exclusion Criteria:
- Creatinine > 3.0 mg/dL
- ALT, AST and Alkaline Phosphatase > 5.0 times the upper limit of normal
- Bilirubin > 3.0 mg/dL
- Patients with grade 3 or higher toxicities (using the CTCAE v3.0) related to cardiac,
neurological, pulmonary or gastrointestinal function as determined by physical exam.
Patients must have normal blood pressure for age.
- Progressive disease
- History of allergy to mouse proteins.
- Active life-threatening infection.
- Human anti-mouse antibody (HAMA) titer >1000 Elisa units/ml.
- Inability to comply with protocol requirements
We found this trial at
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Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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