Completed

Phase II Study of Adjuvant Therapy With Antiganglioside GD2-Specific Mouse Monoclonal Antibody 3F8 for Metastatic Neuroblastoma in Second Remission

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What is being tested

monoclonal antibody 3F8

Biological
Who is being recruted

Neoplasms+7

+ Neoplasms by Histologic Type

+ Neoplasms, Germ Cell and Embryonal

Until 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: November 1987
See protocol details

Summary

Principal SponsorMemorial Sloan Kettering Cancer Center
Last updated: June 5, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 1987

Actual date on which the first participant was enrolled.

OBJECTIVES: I. Evaluate the efficacy of ganglioside GD2-specific monoclonal antibody 3F8 as adjuvant therapy in patients with Stage IV neuroblastoma in second remission. OUTLINE: Biological Response Modifier Therapy. Antiganglioside GD2-specific Monoclonal Antibody 3F8, MOAB 3F8. PROJECTED ACCRUAL: A maximum of 20 patients will be entered.

NCT00002458
Principal SponsorMemorial Sloan Kettering Cancer Center
Last updated: June 5, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Until 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

NeoplasmsNeoplasms by Histologic TypeNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueNeuroectodermal TumorsNeuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroblastoma

Criteria

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Memorial Sloan-Kettering Cancer Center

New York, United StatesOpen Memorial Sloan-Kettering Cancer Center in Google Maps
CompletedOne Study Center