NCT00089258

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. Beta-glucan, isotretinoin, and sargramostim may increase the effectiveness of monoclonal antibody 3F8 by making tumor cells more sensitive to the monoclonal antibody. Combining different types of biological therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving beta-glucan, isotretinoin, and sargramostim together with monoclonal antibody 3F8 works in treating patients with neuroblastoma that has not responded to previous treatment.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at P50-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

July 1, 2004

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 4, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 5, 2004

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
Last Updated

January 17, 2013

Status Verified

January 1, 2013

Enrollment Period

2.3 years

First QC Date

August 4, 2004

Last Update Submit

January 15, 2013

Conditions

Neuroblastoma

Keywords

localized unresectable neuroblastomadisseminated neuroblastomaregional neuroblastomastage 4S neuroblastomarecurrent neuroblastoma

Outcome Measures

Primary Outcomes (1)

  • Disease response as assessed by PT-PC at the end of 4 courses

Interventions

beta-glucanBIOLOGICAL
monoclonal antibody 3F8BIOLOGICAL
sargramostimBIOLOGICAL
isotretinoinDRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of neuroblastoma, as defined by 1 of the following: * Histologically confirmed disease * Bone marrow metastases plus high urine catecholamines * High-risk disease meeting 1 of the following stage criteria: * Stage IV, with 1 of the following: * Any age with MYCN amplification * \> 18 months of age without MYCN amplification * Stage III, with both of the following: * Any age with MYCN amplification * Unresectable disease * Stage 4S with MYCN amplification * Measurable or evaluable soft tissue disease * Relapsed disease resistant to standard induction chemotherapy and salvage therapy PATIENT CHARACTERISTICS: Age * Any age Performance status * Not specified Life expectancy * Not specified Hematopoietic * Not specified Hepatic * No severe hepatic toxicity ≥ grade 3 Renal * No severe renal toxicity ≥ grade 3 Cardiovascular * No severe cardiac toxicity ≥ grade 3 Pulmonary * No severe pulmonary toxicity ≥ grade 3 Other * Not pregnant * Negative pregnancy test * No severe neurologic toxicity ≥ grade 3 * No severe gastrointestinal toxicity ≥ grade 3 * No other severe major organ dysfunction except ototoxicity * No history of allergy to mouse proteins * No active life-threatening infection * No human anti-mouse antibody titer \> 1,000 ELISA units/mL PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * See Disease Characteristics Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * 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, 10021, United States

Location

MeSH Terms

Conditions

Neuroblastoma

Interventions

beta-Glucanshumanized 3F8 anti-GD2 monoclonal antibodysargramostimIsotretinoin

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)

GlucansPolysaccharidesCarbohydratesRetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesPigments, 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

August 4, 2004

First Posted

August 5, 2004

Study Start

July 1, 2004

Primary Completion

November 1, 2006

Last Updated

January 17, 2013

Record last verified: 2013-01

Locations

US(1)