Trials / Completed
CompletedNCT03033303
A Study of the Effect of Hu3F8/GM-CSF Immunotherapy Plus Isotretinoin in Patients in First Remission of High-Risk Neuroblastoma
Hu3F8/GM-CSF Immunotherapy Plus Isotretinoin for Consolidation of First Remission of Patients With High-Risk Neuroblastoma: A Phase II Study
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 59 (actual)
- Sponsor
- Memorial Sloan Kettering Cancer Center · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to test see the combined effects of the study drug called Humanized 3F8 (Hu3F8) when used with granulocyte-macrophage colony stimulating factor (GM-CSF). Hu3F8 plus GM-CSF could prevent your neuroblastoma from growing, but it could also cause side effects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Hu3F8 | Day 1: hu3F8 infused iv over \~30 to 90 minutes. Day 3: hu3F8 infused iv over \~30 to 90 minutes. Day 5: hu3F8 infused iv over \~30 to 90 minutes. |
| DRUG | GM-CSF | Days -4 to 0: GM-CSF 250 mcg/m2/day, subcutaneously. Days 1 to 5: GM-CSF 500 mcg/m2/day, subcutaneously. |
| DRUG | Isotretinoin | Isotretinoin is administered at 160 mg/m2/d, divided into two doses, x14 days. |
Timeline
- Start date
- 2017-01-23
- Primary completion
- 2025-09-29
- Completion
- 2025-09-29
- First posted
- 2017-01-26
- Last updated
- 2025-10-07
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03033303. Inclusion in this directory is not an endorsement.