Trials / Completed
CompletedNCT01183897
3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid for Primary Refractory Neuroblastoma in Bone Marrow
3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid for Primary Refractory Neuroblastoma in Bone Marrow: A Phase II Study
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 31 (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 see 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 | This phase II, open-label, single arm trial assesses the anti-NB activity of high-dose 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 (20mg/m2/day) for all cycles The patients have primary refractory BM disease. Protocol treatment is through 24 months. Real-time quantitative RT-PCR63-65 will be used to assess MRD in BM. 13-cis-retinoic acid is started no later than after cycle 4 (i.e., after response is scored), but sooner if CR is achieved after cycles 1, 2, or 3, or if early HAMA develops. |
Timeline
- Start date
- 2010-08-12
- Primary completion
- 2018-09-25
- Completion
- 2018-09-25
- First posted
- 2010-08-18
- Last updated
- 2019-08-13
- Results posted
- 2019-08-13
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01183897. Inclusion in this directory is not an endorsement.