Trials / Terminated
TerminatedNCT01183884
3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid for Consolidation of Second or Greater Remission of High-Risk Neuroblastoma
3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid for Consolidation of Second or Greater Remission of High-Risk Neuroblastoma: A Phase II Study
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 46 (actual)
- Sponsor
- Memorial Sloan Kettering Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Months
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | 3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid | 3F8 (80 mg/m2/day), which is used in cycles 1-2, with return to standard 3F8 dosage (20 mg/m2/day) in subsequent cycles .Clinical results will be compared to those in the predecessor trials which used only the standard 3F8 dosage. Starting with A(6), patients no longer receive high-dose 3F8 but receive only standard dose 3F8 (20 mg/m2/day) for all cycles. The patients are in \> or = to 2nd CR/VGPR and at high risk for additional relapse. Real-time quantitative RT-PCR63-65 will be used to assess MRD in BM. 13-cis-retinoic acid is started after cycle 2. |
Timeline
- Start date
- 2010-08-01
- Primary completion
- 2018-11-09
- Completion
- 2018-11-09
- First posted
- 2010-08-18
- Last updated
- 2019-11-14
- Results posted
- 2019-11-14
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01183884. Inclusion in this directory is not an endorsement.