NCT01183429

3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid for Consolidation of First Remission After Non-Myeloablative Therapy in Patients With High-Risk Neuroblastoma

Completed Phase 2 Results posted Last updated 13 August 2019

What this trial tests

Phase 2 trial testing 3F8 and 13-cis-retinoic acid in Neuroblastoma in 39 participants. Completed in 13 September 2018.

Timeline

12 August 2010

Primary endpoint
13 September 2018

13 September 2018

Quick facts

Lead sponsor	Memorial Sloan Kettering Cancer Center
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	39
Start date	12 August 2010
Primary completion	13 September 2018
Estimated completion	13 September 2018
Sites	1 location across United States

Drugs / interventions tested

• 3F8 and 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.

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.

Antibodies are made by the body to attack tumors and to fight infections. 3F8 is the name of one kind of antibody. It is made by mice, and it can attack neuroblastoma in people. 3F8 has been used safely in many patients, and it has killed cancer cells in some patients. One way it can kill cancer cells is by causing the patient's own white blood cells to attack the cancer. Granulocytes are one kind of white blood cell. GM-CSF increases the number of granulocytes in people, and it makes the granulocytes better able to kill the cancer cells.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Advances and challenges in retinoid delivery systems in regenerative and therapeutic medicine.
   Ferreira R, Napoli J, Enver T, Bernardino L, et al · · 2020 · cited 81× · PMID 32848154 · DOI 10.1038/s41467-020-18042-2
2. 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
3. GD2-targeted immunotherapy and radioimmunotherapy.
   Dobrenkov K, Cheung NK. · · 2014 · cited 65× · PMID 25440605 · DOI 10.1053/j.seminoncol.2014.07.003
4. Retinoids as Chemo-Preventive and Molecular-Targeted Anti-Cancer Therapies.
   Hunsu VO, Facey COB, Fields JZ, Boman BM. · · 2021 · cited 62× · PMID 34299349 · DOI 10.3390/ijms22147731
5. Targeting the Tumor Microenvironment in Neuroblastoma: Recent Advances and Future Directions.
   Joshi S. · · 2020 · cited 58× · PMID 32722460 · DOI 10.3390/cancers12082057
6. Lack of survival advantage with autologous stem-cell transplantation in high-risk neuroblastoma consolidated by anti-GD2 immunotherapy and isotretinoin.
   Kushner BH, Ostrovnaya I, Cheung IY, Kuk D, et al · · 2016 · cited 50× · PMID 26623730 · DOI 10.18632/oncotarget.6393
7. 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
8. Immunotherapeutic Strategies for Neuroblastoma: Present, Past and Future.
   Morandi F, Sabatini F, Podestà M, Airoldi I. · · 2021 · cited 30× · PMID 33450862 · DOI 10.3390/vaccines9010043