3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid for Consolidation of First Remission After Non-Myeloablative Therapy in Patients With High-Risk Neuroblastoma
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/6/2019 |
| Start Date: | August 2010 |
| End Date: | August 2020 |
3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid for Consolidation of First Remission After Non-Myeloablative Therapy in Patients With High-Risk Neuroblastoma: A Phase II Study
The purpose of this study is to find out what effects, good and/or bad, the combination of
3F8 and GM-CSF has on the patient and the cancer.
Antibodies are made by the body to attack tumors and to fight infections. 3F8 is the name of
one kind of antibody. It is made by mice, and it can attack neuroblastoma in people. 3F8 has
been used safely in many patients, and it has killed cancer cells in some patients. One way
it can kill cancer cells is by causing the patient's own white blood cells to attack the
cancer. Granulocytes are one kind of white blood cell. GM-CSF increases the number of
granulocytes in people, and it makes the granulocytes better able to kill the cancer cells.
3F8 and GM-CSF has on the patient and the cancer.
Antibodies are made by the body to attack tumors and to fight infections. 3F8 is the name of
one kind of antibody. It is made by mice, and it can attack neuroblastoma in people. 3F8 has
been used safely in many patients, and it has killed cancer cells in some patients. One way
it can kill cancer cells is by causing the patient's own white blood cells to attack the
cancer. Granulocytes are one kind of white blood cell. GM-CSF increases the number of
granulocytes in people, and it makes the granulocytes better able to kill the cancer cells.
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 (≥18 months of age) MYCN
amplification, MYCN-amplified stage 2 or stage 3 (any age), or MYCN-amplified stage
4S.
- The patients are in first CR/VGPR after conventional therapy. They have 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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