NCT00004110

Brief Summary

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody therapy plus etoposide in treating patients who have neuroblastoma.

Trial Health

80
On Track

Trial Health Score

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

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

August 1, 1999

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 10, 1999

Completed
3.1 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2004

Completed
Last Updated

October 31, 2013

Status Verified

October 1, 2013

Enrollment Period

5.1 years

First QC Date

December 10, 1999

Last Update Submit

October 30, 2013

Conditions

Neuroblastoma

Keywords

regional neuroblastomadisseminated neuroblastomarecurrent neuroblastomalocalized unresectable neuroblastoma

Interventions

monoclonal antibody 3F8BIOLOGICAL
etoposideDRUG
isotretinoinDRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * High-risk neuroblastoma by: * Histopathology OR * Bone marrow involvement plus elevated urinary catecholamines * Prior tumor progression on standard chemotherapy and poor long-term prognosis as indicated by 1 or more of the following: * N-myc amplification in tumor cells * Diploid chromosomal content plus lp loss of heterozygosity in tumor cells * Distant skeletal metastases * Unresectable primary tumor infiltrating across the midline * More than 10% tumor cells in bone marrow * Less than 30% chance of long-term progression-free survival * Evaluable (microscopic marrow metastasis, elevated tumor markers, abnormal bone scan or MIBG or PET scan) but not measurable (CT scan, MRI) disease documented at least 4 weeks after completion of prior systemic therapy * No rapidly progressive disease as defined by 1 or more of the following: * Serum lactic dehydrogenase greater than 1.5 times upper limit of normal due to tumor * An opiate requirement for pain from tumor * Greater than 25% increase in tumor by successive imaging studies * Life expectancy less than 8 weeks * Second or subsequent remission after chemotherapy and/or radiotherapy allowed provided there is less than 30% chance of survival * No prior myelodysplastic syndromes or leukemia PATIENT CHARACTERISTICS: Age: * Not specified Performance status: * Not specified Life expectancy: * See Disease Characteristics * At least 8 weeks Hematopoietic: * Not specified Hepatic: * No grade 3 or worse liver toxicity Renal: * No grade 3 or worse renal toxicity * Creatinine clearance at least 60 mL/min Cardiovascular: * No grade 3 or worse cardiac toxicity Pulmonary: * No grade 3 or worse pulmonary toxicity Other: * Not pregnant * No grade 3 or worse gastrointestinal toxicity * No grade 3 or worse neurologic system toxicity * No grade 4 hearing deficit * No active life-threatening infection * No prior exposure to mouse antibodies and human anti-mouse antibody greater than 1,000 ELISA units/mL * No allergy to mouse proteins PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * See Disease Characteristics Endocrine therapy: * Not specified Radiotherapy: * See Disease Characteristics Surgery: * See Disease Characteristics

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 antibodyEtoposideIsotretinoin

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)

PodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsGlucosidesGlycosidesCarbohydratesRetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicTerpenesPigments, BiologicalBiological Factors

Study Officials

  • Nai-Kong V. Cheung, MD, PhD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 10, 1999

First Posted

January 27, 2003

Study Start

August 1, 1999

Primary Completion

September 1, 2004

Last Updated

October 31, 2013

Record last verified: 2013-10

Locations

US(1)