NCT00450307

Brief Summary

RATIONALE: Monoclonal antibodies, such as 3F8, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood. Giving monoclonal antibody therapy together with GM-CSF may be an effective treatment for neuroblastoma. PURPOSE: This phase I trial is studying the side effects and best dose of monoclonal antibody 3F8 when given together with GM-CSF in treating young patients with high-risk, refractory or relapsed neuroblastoma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jun 2005

Longer than P75 for phase_1

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

June 1, 2005

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

March 20, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 22, 2007

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

October 16, 2013

Status Verified

October 1, 2013

Enrollment Period

7.8 years

First QC Date

March 20, 2007

Last Update Submit

October 14, 2013

Conditions

Neuroblastoma

Keywords

recurrent neuroblastomastage 4S neuroblastomadisseminated neuroblastomalocalized unresectable neuroblastomaregional neuroblastoma

Outcome Measures

Primary Outcomes (2)

  • Maximum tolerated dose of monoclonal antibody 3F8

    2 years

  • Anti-neuroblastoma effects of monoclonal antibody 3F8 and sargramostim (GM-CSF)

    2 years

Study Arms (1)

3F8 and GM-CSF

EXPERIMENTAL

One cycle has 5 days of 3F8 treatment. Each day, patients receive GM-CSF subcutaneously \~1.5 hr before the start 3F8 infusion. To limit side-effects, patients receive analgesics, antihistamines, and a small dose (IV, over \~5 minutes) of heat-modified 3F8. Cycles can be repeated after a 2-4 week interval, up to a total of two cycles.

Biological: monoclonal antibody 3F8Biological: sargramostim

Interventions

monoclonal antibody 3F8BIOLOGICAL
3F8 and GM-CSF
sargramostimBIOLOGICAL
3F8 and GM-CSF

Eligibility Criteria

AgeUp to 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients must have a diagnosis of NB as defined by international criteria,45 i.e., histopathology (confirmed by the MSKCC Department of Pathology) or BM metastases plus high urine catecholamine levels.
  • Patients must have refractory or relapsed high-risk NB (including MYCNamplified stage 3/4/4S and MYCN-nonamplified stage 4 \>18 months old) resistant to standard therapy.
  • Prior treatment with 3F8 is allowed.
  • Age \<21 years.
  • Signed informed consent indicating awareness of the investigational nature of this program.

You may not qualify if:

  • Existing major organ dysfunction should be grade 2 or less, with the exception of myelosuppression (neutrophil count \>500/ul and platelet count \>10,000/ul are acceptable), alopecia, hearing loss. Patient cannot be taking antihypertensive medication.
  • History of allergy to mouse proteins.
  • Active life-threatening infection.
  • Human anti-mouse antibody (HAMA) titer \>1000 ELISA units/ml.
  • Inability to comply with protocol requirements.
  • Pregnant women are excluded for fear of danger to the fetus. Therefore negative pregnancy test is required for all women of child-bearing age, and appropriate contraception is used during the study period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Publications (1)

  • Kushner BH, Kramer K, Modak S, Cheung NK. Successful multifold dose escalation of anti-GD2 monoclonal antibody 3F8 in patients with neuroblastoma: a phase I study. J Clin Oncol. 2011 Mar 20;29(9):1168-74. doi: 10.1200/JCO.2010.28.3317. Epub 2011 Feb 22.

    PMID: 21343563RESULT

MeSH Terms

Conditions

Neuroblastoma

Interventions

humanized 3F8 anti-GD2 monoclonal antibodysargramostim

Condition Hierarchy (Ancestors)

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

Study Officials

  • Brian H. Kushner, MD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2007

First Posted

March 22, 2007

Study Start

June 1, 2005

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

October 16, 2013

Record last verified: 2013-10

Locations

US(1)