NCT00002458

Brief Summary

RATIONALE: 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 monoclonal antibody in treating children with metastatic neuroblastoma in second remission.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Nov 1987

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 1987

Completed
12 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2001

Completed
3 years until next milestone

First Posted

Study publicly available on registry

August 30, 2004

Completed
Last Updated

June 5, 2013

Status Verified

June 1, 2013

Enrollment Period

13.8 years

First QC Date

November 1, 1999

Last Update Submit

June 4, 2013

Conditions

Neuroblastoma

Keywords

disseminated neuroblastomarecurrent neuroblastoma

Interventions

monoclonal antibody 3F8BIOLOGICAL

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
DISEASE CHARACTERISTICS: Histologically confirmed, Stage IV neuroblastoma in second or subsequent complete remission, defined by the complete disappearance of all evidence of tumor on the following: Physical examination Second-look surgery Bone scan Bone marrow aspiration and biopsy Chest x-ray CT MIBG Urinary catecholamines If marrow is infiltrated by tumor, complete elimination of tumor cells from the marrow compartment must be demonstrated by histology and immunofluorescence (based on simultaneous bone marrow aspiration and biopsy samples from at least 4 separate sites) PATIENT CHARACTERISTICS: Age: Under 18 Performance status: Not specified Life expectancy: Greater than 12 weeks Hematopoietic: Grade 4 cytopenias allowed Grade 3 marrow hypoplasia allowed Hepatic: Not specified Renal: No renal dysfunction worse than grade 3 Cardiovascular: No cardiac dysfunction worse than grade 2 Pulmonary: No pulmonary dysfunction worse than grade 2 Other: No neurologic dysfunction worse than grade 2 Hearing deficit allowed PRIOR CONCURRENT THERAPY: Prior murine antibody therapy allowed provided circulating HAMA titer is less than 1,000 U/mL serum by ELISA

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, 10021, United States

Location

MeSH Terms

Conditions

Neuroblastoma

Interventions

humanized 3F8 anti-GD2 monoclonal antibody

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

  • Nai-Kong V. Cheung, MD, PhD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

August 30, 2004

Study Start

November 1, 1987

Primary Completion

September 1, 2001

Study Completion

September 1, 2001

Last Updated

June 5, 2013

Record last verified: 2013-06

Locations

US(1)