NCT01662804

Humanized 3F8 Monoclonal Antibody (Hu3F8) When Combined With Interleukin-2 in Patients With High-Risk Neuroblastoma and GD2-positive Solid Tumors

Completed Phase 1 Last updated 27 May 2021

What this trial tests

Phase 1 trial testing 3F8 Monoclonal Antibody Combined with Interleukin-2 in Neuroblastoma in 14 participants. Completed in 25 May 2021.

Timeline

6 August 2012

Primary endpoint
25 May 2021

25 May 2021

Quick facts

Lead sponsor	Memorial Sloan Kettering Cancer Center
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	14
Start date	6 August 2012
Primary completion	25 May 2021
Estimated completion	25 May 2021
Sites	1 location across United States

Drugs / interventions tested

• 3F8 Monoclonal Antibody Combined with Interleukin-2 — full drug profile →

Conditions studied

• Neuroblastoma — all drugs for Neuroblastoma →

Sponsor

Memorial Sloan Kettering Cancer Center — full company profile →

Who can join

13 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 if "humanized 3F8" (Hu3F8) when combined with interleukin-2 (rIL2) is safe for treating neuroblastoma and other cancers. A phase 1 study means the investigators are trying to find out what side effects happen when higher and higher doses of a drug are used.

The investigators want to find out what effects, good and/or bad, Hu3F8 combined with rIL2 has on cancer. The amount of Hu3F8 that patients gets will depend on when they start treatment on this study. The amount of rIL2 will be the same for all patients. The investigators also want to find out more about how Hu3F8 works and how effective it is in attacking the disease when combined with rIL2.

Publications & conference data

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

1. NK Cell-Mediated Antibody-Dependent Cellular Cytotoxicity in Cancer Immunotherapy.
   Wang W, Erbe AK, Hank JA, Morris ZS, et al · · 2015 · cited 421× · PMID 26284063 · DOI 10.3389/fimmu.2015.00368
2. Anti-GD2 immunotherapy for neuroblastoma.
   Sait S, Modak S. · · 2017 · cited 155× · PMID 28780888 · DOI 10.1080/14737140.2017.1364995
3. 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
4. Pediatric Cancer Immunotherapy: Opportunities and Challenges.
   Wedekind MF, Denton NL, Chen CY, Cripe TP. · · 2018 · cited 78× · PMID 29948928 · DOI 10.1007/s40272-018-0297-x
5. GD2-targeted immunotherapy and radioimmunotherapy.
   Dobrenkov K, Cheung NK. · · 2014 · cited 65× · PMID 25440605 · DOI 10.1053/j.seminoncol.2014.07.003
6. Immunotherapy of Pediatric Solid Tumors: Treatments at a Crossroads, with an Emphasis on Antibodies.
   Casey DL, Cheung NV. · · 2020 · cited 64× · PMID 32015013 · DOI 10.1158/2326-6066.cir-19-0692
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. Immunotherapy of Childhood Sarcomas.
   Roberts SS, Chou AJ, Cheung NK. · · 2015 · cited 49× · PMID 26301204 · DOI 10.3389/fonc.2015.00181