NCT00002634

N7: EVALUATION OF MAXIMAL CHEMOTHERAPY DOSE INTENSITY PLUS MONOCLONAL ANTIBODY 3F8 IN THE TREATMENT OF NEUROBLASTOMA

Completed Phase 2 Last updated 1 July 2013

What this trial tests

Phase 2 trial testing filgrastim in Neuroblastoma in 45 participants. Completed in 1 September 2004.

Timeline

1 February 1995

Primary endpoint
1 September 2004

1 September 2004

Quick facts

Lead sponsor	Memorial Sloan Kettering Cancer Center
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Primary purpose	treatment
Enrollment	45
Start date	1 February 1995
Primary completion	1 September 2004
Estimated completion	1 September 2004
Sites	1 location across United States

Drugs / interventions tested

• filgrastim
• monoclonal antibody 3F8
• cisplatin (cisplatin) — full drug profile →
• cyclophosphamide (cyclophosphamide) — full drug profile →
• doxorubicin hydrochloride — full drug profile →
• etoposide
• mesna
• perfosfamide (PERFOSFAMIDE) — full drug profile →
• vincristine sulfate (Vincristine Sulfate) — full drug profile →
• autologous bone marrow transplantation
• in vitro-treated bone marrow transplantation
• low-LET cobalt-60 gamma ray therapy
• low-LET photon therapy
• radioisotope therapy

Conditions studied

• Neuroblastoma — all drugs for Neuroblastoma →

Sponsor

Memorial Sloan Kettering Cancer Center — full company profile →

Who can join

1 and older, any sex, with Neuroblastoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Radiation therapy uses high-energy x-rays to damage tumor cells. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy, radiation therapy, immunotherapy, and bone marrow transplantation in treating patients with neuroblastoma.

Publications & conference data

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

1. Murine anti-GD2 monoclonal antibody 3F8 combined with granulocyte-macrophage colony-stimulating factor and 13-cis-retinoic acid in high-risk patients with stage 4 neuroblastoma in first remission.
   Cheung NK, Cheung IY, Kushner BH, Ostrovnaya I, et al · · 2012 · cited 204× · PMID 22869886 · DOI 10.1200/jco.2011.41.3807
2. KIR and HLA genotypes are associated with disease progression and survival following autologous hematopoietic stem cell transplantation for high-risk neuroblastoma.
   Venstrom JM, Zheng J, Noor N, Danis KE, et al · · 2009 · cited 104× · PMID 19934297 · DOI 10.1158/1078-0432.ccr-09-1720
3. Spotlight on dinutuximab in the treatment of high-risk neuroblastoma: development and place in therapy.
   Keyel ME, Reynolds CP. · · 2019 · cited 62× · PMID 30613134 · DOI 10.2147/btt.s114530
4. Neuroblastoma Patients' KIR and KIR-Ligand Genotypes Influence Clinical Outcome for Dinutuximab-based Immunotherapy: A Report from the Children's Oncology Group.
   Erbe AK, Wang W, Carmichael L, Kim K, et al · · 2018 · cited 50× · PMID 28972044 · DOI 10.1158/1078-0432.ccr-17-1767
5. Bone marrow minimal residual disease was an early response marker and a consistent independent predictor of survival after anti-GD2 immunotherapy.
   Cheung NK, Ostrovnaya I, Kuk D, Cheung IY. · · 2015 · cited 42× · PMID 25559819 · DOI 10.1200/jco.2014.57.6777
6. The anti-GD2 monoclonal antibody naxitamab plus GM-CSF for relapsed or refractory high-risk neuroblastoma: a phase 2 clinical trial.
   Mora J, Chan GCF, Morgenstern DA, Amoroso L, et al · · 2025 · cited 15× · PMID 39952926 · DOI 10.1038/s41467-025-56619-x
7. Immunotherapy with anti-G_D2 monoclonal antibody in infants with high-risk neuroblastoma.
   Kushner BH, Modak S, Kramer K, Basu EM, et al · · 2023 · cited 8× · PMID 35913764 · DOI 10.1002/ijc.34233