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NCT01183884
3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid for Consolidation of Second or Greater Remission of High-Risk Neuroblastoma: A Phase II Study
Phase 2 trial testing 3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid in Neuroblastoma in 46 participants. Terminated before completion.
9 November 2018
Quick facts
| Lead sponsor | Memorial Sloan Kettering Cancer Center |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 46 |
| Start date | 1 August 2010 |
| Primary completion | 9 November 2018 |
| Estimated completion | 9 November 2018 |
| Sites | 1 location across United States |
Drugs / interventions tested
- 3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid — full drug profile →
Conditions studied
- Neuroblastoma — all drugs for Neuroblastoma →
Sponsor
Memorial Sloan Kettering Cancer Center — full company profile →
Who can join
18 Months and older, any sex, with Neuroblastoma. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Assess the Impact of High-dose 3F8/GM-CSF on Relapse-free Survival
Time frame: 2 years
in patients in second or greater complete or very good partial remission, but at high risk of additional relapse.
Sponsor's own description
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Neuroblastoma Origin and Therapeutic Targets for Immunotherapy.
Kholodenko IV, Kalinovsky DV, Doronin II, Deyev SM, et al · · 2018 · cited 122× · PMID 30116755 · DOI 10.1155/2018/7394268 -
PD-L1, inflammation, non-coding RNAs, and neuroblastoma: Immuno-oncology perspective.
Nallasamy P, Chava S, Verma SS, Mishra S, et al · · 2018 · cited 67× · PMID 29196189 · DOI 10.1016/j.semcancer.2017.11.009 -
GD2-targeted immunotherapy and radioimmunotherapy.
Dobrenkov K, Cheung NK. · · 2014 · cited 65× · PMID 25440605 · DOI 10.1053/j.seminoncol.2014.07.003 -
Targeting the Tumor Microenvironment in Neuroblastoma: Recent Advances and Future Directions.
Joshi S. · · 2020 · cited 58× · PMID 32722460 · DOI 10.3390/cancers12082057 -
New Strategies Using Antibody Combinations to Increase Cancer Treatment Effectiveness.
Corraliza-Gorjón I, Somovilla-Crespo B, Santamaria S, Garcia-Sanz JA, et al · · 2017 · cited 49× · PMID 29312320 · DOI 10.3389/fimmu.2017.01804 -
Novel Therapies for Relapsed and Refractory Neuroblastoma.
Zage PE. · · 2018 · cited 39× · PMID 30384486 · DOI 10.3390/children5110148 -
Posterior reversible encephalopathy syndrome in neuroblastoma patients receiving anti-GD2 3F8 monoclonal antibody.
Kushner BH, Modak S, Basu EM, Roberts SS, et al · · 2013 · cited 20× · PMID 23633099 · DOI 10.1002/cncr.28137 -
NK cell-based immunotherapies in Pediatric Oncology.
McDowell KA, Hank JA, DeSantes KB, Capitini CM, et al · · 2015 · cited 17× · PMID 25590232 · DOI 10.1097/mph.0000000000000303
Verify or expand the search:
- PubMed search for NCT01183884
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Neuroblastoma
Currently open trials in the same condition.
- NCT07399821 — An Imaging Study of Anti-GD2-800CW in Patients With Neuroblastoma · Phase 1, PHASE2 · recruiting
- NCT06995872 — Phase I Trial of rhIL-15 Plus Dinutuximab Plus Irinotecan/Temozolomide for Children and Young Adults With Relapsed/Refra · Phase 1 · recruiting
- NCT06942039 — Pilot Study of IT Topotecan and Maintenance Chemotherapy for HR-EBTs in Children < 6 Years, Post Consolidation · EARLY_PHASE1 · recruiting
- NCT07067346 — Safety & Efficacy of IR-101 in Relapsed/Refractory Neuroblastoma · EARLY_PHASE1 · recruiting
- NCT07027748 — Feasibility Study of Prolonged Administration of Naxitamab, Irinotecan, and Temozolomide for Patients With Relapsed or R · Phase 1 · recruiting
Other Memorial Sloan Kettering Cancer Center trials
Trials by the same sponsor.
- NCT07566377 — Cord Blood Transplantation in Children and Young Adults With Blood Cancer · Phase 2 · recruiting
- NCT07507643 — A Study of Methylprednisolone in People Having Liver Surgery · Phase 3 · recruiting
- NCT07483307 — A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Breast Cancer · Phase 2 · recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01183884 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center
- Last refreshed: 12 November 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01183884.
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