NCT00072358

Brief Summary

RATIONALE: Monoclonal antibodies, such as monoclonal antibody 3F8, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Colony-stimulating factors, such as sargramostim, may increase the number of immune cells found in bone marrow or peripheral blood. Combining monoclonal antibody 3F8 with sargramostim may cause a stronger immune response and kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining monoclonal antibody 3F8 with sargramostim in treating patients who have neuroblastoma.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
291

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2003

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 4, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 6, 2003

Completed
17.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2021

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

May 16, 2022

Completed
Last Updated

May 16, 2022

Status Verified

April 1, 2022

Enrollment Period

17.6 years

First QC Date

November 4, 2003

Results QC Date

January 14, 2022

Last Update Submit

April 21, 2022

Conditions

Neuroblastoma

Keywords

disseminated neuroblastomalocalized unresectable neuroblastomarecurrent neuroblastomaregional neuroblastomastage 4S neuroblastoma

Outcome Measures

Primary Outcomes (2)

  • Efficacy at Completion of Treatment

    3 years

  • Relapse-free Survival Every 3 Months

    3 years

Secondary Outcomes (2)

  • Compare Granulocyte Activation in Patients Treated With Short-term vs Prolonged Daily Exposure to Sargramostim (GM-CSF) After 4 Courses

    3 years

  • Simplify Treatment With Consequent Reduction in Cost

    3 years

Study Arms (2)

patients have refractory bone marrow disease

EXPERIMENTAL

This phase II trial of the anti-GD2 murine IgG3 monoclonal antibody 3F8 combined with granulocyte-macrophage colony stimulating factor (GM-CSF) will assess response of minimal residual disease (MRD) in patients with high-risk neuroblastoma (NB) and help establish the optimal way to use GM-CSF.

Biological: anti-GD2 murine IgG3 monoclonal antibody 3F8

patients have no evidence of disease

EXPERIMENTAL

This phase II trial of the anti-GD2 murine IgG3 monoclonal antibody 3F8 combined with granulocyte-macrophage colony stimulating factor (GM-CSF) will assess response of minimal residual disease (MRD) in patients with high-risk neuroblastoma (NB) and help establish the optimal way to use GM-CSF.

Biological: anti-GD2 murine IgG3 monoclonal antibody 3F8

Interventions

anti-GD2 murine IgG3 monoclonal antibody 3F8BIOLOGICAL

The total dosage of 3F8 per cycle is the same as in prior trials (100 mg/m2), administered at 20 mg/m2/day and infused over \~1.5 hr or less (0.5 hr is customary), with analgesics and antihistamines used as needed for expected side-effects. 3F8 is started \~1 hr after completion of GM-CSF administration. GM-CSF is dosed at 250 mcg/m2/day from day -5 to day +1 (Wednesday to Tuesday is customary) , and is 500 mcg/m2/day thereafter (i.e., on days +2 to +4; Wednesday to Friday), as in the predecessor protocol.18,74 Patients come off study if progressive disease occurs or if there is life-threatening grade 4 toxicity from 3F8; otherwise, patients will receive a minimum of 4 cycles of treatment and will continue treatment through 24 months. It is expected that patients will receive \~10 cycles.

Also known as: patients (enrolled on study for treatment of primary refractory disease), the, break between end of a cycle of 3F8/GM-CSF and start of next cycle is 2-to-4-weeks through 4, cycles after achievement of CR in BM; subsequent breaks are ~8 weeks. In this, group, isotretinoin is started after documentation of response to, and after, >2 cycles of, 3F8/GM-CSF.
patients have refractory bone marrow disease

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of neuroblastoma by histopathology OR bone marrow metastases and high urine catecholamine levels * Disease must meet risk-related treatment guidelines and any of the following International Neuroblastoma Staging System stages: * Stage 4 with (any age) OR without (\> 18 months of age of age) MYCN amplification * MYCN-amplified other than stage 1 * No evidence of disease (i.e., in complete response/remission or very good partial response/remission) OR disease resistant to standard therapy (i.e., incomplete response in bone marrow) * No progressive disease or MIBG-avid soft tissue tumor PATIENT CHARACTERISTICS: * No existing renal, cardiac, hepatic, neurologic, pulmonary, or gastrointestinal toxicity ≥ grade 3 * No human anti-mouse antibody (HAMA) titer greater than 1,000 Elisa units/mL * No history of allergy to mouse proteins * No active life-threatening infection * Not pregnant * Negative pregnancy test PRIOR CONCURRENT THERAPY: * Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Publications (2)

  • Kushner BH, Modak S, Basu EM, Roberts SS, Kramer K, Cheung NK. Posterior reversible encephalopathy syndrome in neuroblastoma patients receiving anti-GD2 3F8 monoclonal antibody. Cancer. 2013 Aug 1;119(15):2789-95. doi: 10.1002/cncr.28137. Epub 2013 Apr 30.

    PMID: 23633099DERIVED

  • Cheung IY, Hsu K, Cheung NK. Activation of peripheral-blood granulocytes is strongly correlated with patient outcome after immunotherapy with anti-GD2 monoclonal antibody and granulocyte-macrophage colony-stimulating factor. J Clin Oncol. 2012 Feb 1;30(4):426-32. doi: 10.1200/JCO.2011.37.6236. Epub 2011 Dec 27.

    PMID: 22203761DERIVED

MeSH Terms

Conditions

Neuroblastoma

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

DemographyPopulation Characteristics

Results Point of Contact

Title
Dr. Brian Kushner, MD
Organization
Memorial Sloan Kettering Cancer Center
kushnerb@MSKCC.ORG
1-833-MSK KIDS

Study Officials

  • Brian H. Kushner, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2003

First Posted

November 6, 2003

Study Start

July 1, 2003

Primary Completion

January 15, 2021

Study Completion

January 15, 2021

Last Updated

May 16, 2022

Results First Posted

May 16, 2022

Record last verified: 2022-04

Locations

US(1)