Monoclonal Antibody 3F8 and Sargramostim in Treating Patients With Neuroblastoma
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 10/6/2018 |
| Start Date: | July 2003 |
| End Date: | December 2019 |
Phase II Study of Anti-GD2 3F8 Antibody and GM-CSF for High-Risk Neuroblastoma
RATIONALE: Monoclonal antibodies, such as monoclonal antibody 3F8, 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. Combining monoclonal antibody 3F8 with sargramostim
may cause a stronger immune response and kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining monoclonal antibody 3F8 with
sargramostim in treating patients who have neuroblastoma.
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. Combining monoclonal antibody 3F8 with sargramostim
may cause a stronger immune response and kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining monoclonal antibody 3F8 with
sargramostim in treating patients who have neuroblastoma.
OBJECTIVES:
- Determine the efficacy of sargramostim (GM-CSF) in enhancing monoclonal antibody
3F8-mediated ablation in patients with high-risk neuroblastoma.
- Determine the prognostic impact of minimal residual bone marrow disease on relapse-free
survival of patients treated with this regimen.
- Compare the effects of short-term (2-hour intravenous) vs prolonged (subcutaneous
release) daily GM-CSF on granulocyte activation, in order to establish the optimal route
for tumor-cell kill in these patients.
OUTLINE: This is an open-label study. Patients are stratified according to evaluable disease
(yes [primary refractory bone marrow disease] vs no [no evidence of disease]).
Patients receive sargramostim (GM-CSF) subcutaneously on days -5 to 4 and monoclonal antibody
3F8 IV over 0.5-1.5 hours on days 0-4. Treatment repeats every 3 weeks for 4 courses and then
every 8 weeks for up to a total of 24 months in the absence of disease progression or
unacceptable toxicity.
Beginning after 2 courses of GM-CSF and monoclonal antibody 3F8, patients also receive oral
isotretinoin twice daily on days 1-14 (when no monoclonal antibody 3F8 is administered).
Treatment with isotretinoin repeats approximately every 28 days for 6 courses.
PROJECTED ACCRUAL: A total of 340 patients will be accrued for this study.
- Determine the efficacy of sargramostim (GM-CSF) in enhancing monoclonal antibody
3F8-mediated ablation in patients with high-risk neuroblastoma.
- Determine the prognostic impact of minimal residual bone marrow disease on relapse-free
survival of patients treated with this regimen.
- Compare the effects of short-term (2-hour intravenous) vs prolonged (subcutaneous
release) daily GM-CSF on granulocyte activation, in order to establish the optimal route
for tumor-cell kill in these patients.
OUTLINE: This is an open-label study. Patients are stratified according to evaluable disease
(yes [primary refractory bone marrow disease] vs no [no evidence of disease]).
Patients receive sargramostim (GM-CSF) subcutaneously on days -5 to 4 and monoclonal antibody
3F8 IV over 0.5-1.5 hours on days 0-4. Treatment repeats every 3 weeks for 4 courses and then
every 8 weeks for up to a total of 24 months in the absence of disease progression or
unacceptable toxicity.
Beginning after 2 courses of GM-CSF and monoclonal antibody 3F8, patients also receive oral
isotretinoin twice daily on days 1-14 (when no monoclonal antibody 3F8 is administered).
Treatment with isotretinoin repeats approximately every 28 days for 6 courses.
PROJECTED ACCRUAL: A total of 340 patients will be accrued for this study.
DISEASE CHARACTERISTICS:
- Diagnosis of neuroblastoma by histopathology OR bone marrow metastases and high urine
catecholamine levels
- Disease must meet risk-related treatment guidelines and any of the following
International Neuroblastoma Staging System stages:
- Stage 4 with (any age) OR without (> 18 months of age of age) MYCN amplification
- MYCN-amplified other than stage 1
- No evidence of disease (i.e., in complete response/remission or very good partial
response/remission) OR disease resistant to standard therapy (i.e., incomplete
response in bone marrow)
- No progressive disease or MIBG-avid soft tissue tumor
PATIENT CHARACTERISTICS:
- No existing renal, cardiac, hepatic, neurologic, pulmonary, or gastrointestinal
toxicity ≥ grade 3
- No human anti-mouse antibody (HAMA) titer greater than 1,000 Elisa units/mL
- No history of allergy to mouse proteins
- No active life-threatening infection
- Not pregnant
- Negative pregnancy test
PRIOR CONCURRENT THERAPY:
- Not specified
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