Monoclonal Antibody Therapy Plus Sargramostin in Treating Patients With Advanced Neuroblastoma

NCT00002560 | Completed Phase 2

• 3 other identifiers: 94-018CDR0000063466NCI-V94-0416
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining colony-stimulating factors, such as sargramostim, with monoclonal antibodies may be an effective treatment for advanced neuroblastoma. PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody 3F8 plus sargramostim in treating patients who have advanced neuroblastoma.

Conditions

Neuroblastoma

Keywords

recurrent neuroblastoma

Interventions

monoclonal antibody 3F8 BIOLOGICAL

sargramostim BIOLOGICAL

Eligibility Criteria

• Age: 2 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

DISEASE CHARACTERISTICS: * Neuroblastoma diagnosed by INSS criteria, i.e., either: * Histologic proof of disease OR * Tumor clumps in bone marrow plus elevated catecholamine levels * Relapsed disease with poor long-term prognosis as indicated by at least one of the following: * N-myc amplification in tumor cells * Diploid chromosomal content in tumor cells * Distant skeletal metastases * Unresectable primary tumor crossing the midline * Bone marrow with greater than 10% tumor cells * Documentation of measurable progressive disease or biopsy- proven stable disease at least 4 weeks after prior systemic therapy required * No rapidly progressive disease * Poor risk neuroblastoma (but without measurable disease) not eligible for other neuroblastoma protocols PATIENT CHARACTERISTICS: Age: * 2 to 21 Performance status: * Not specified Life expectancy: * Greater than 8 weeks Hematologic: * Not specified Hepatic: * No grade 3/4 toxicity * LDH no greater than 1.5 times upper limit of normal Renal: * Creatinine clearance at least 60 mL/min * No grade 3/4 toxicity Cardiovascular: * No grade 3/4 toxicity Pulmonary: * No grade 3/4 toxicity Other: * No grade 3/4 neurologic, gastrointestinal, or other organ toxicity except grade 3 hearing deficit * No active life threatening infections * No human antimouse antibody (HAMA) greater than 1,000 ELISA units/mL * No allergy to mouse proteins * No pain requiring opiates PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Standard chemotherapy to which disease is resistant or myeloablative therapy followed by disease recurrence required 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

• Memorial Sloan Kettering Cancer Center: lead

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; sargramostim

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Brian H. Kushner, MD

  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: January 27, 2003
• Study Start: February 1, 1994
• Primary Completion: April 1, 2005
• Study Completion: April 1, 2005
• Last Updated: June 28, 2013

Record last verified: 2013-06

Locations

US (1)