PHASE II TRIAL OF MONOCLONAL ANTIBODY 3F8 AND GRANULOCYTE-MACROPHAGE COLONY-STIMULATING FACTOR (GM-CSF) FOR NEUROBLASTOMA
monoclonal antibody 3F8
+ sargramostim
Neoplasms+7
+ Neoplasms by Histologic Type
+ Neoplasms, Germ Cell and Embryonal
Treatment Study
Summary
Study start date: February 1, 1994
Actual date on which the first participant was enrolled.OBJECTIVES: Define the antitumor effects of monoclonal antibody 3F8/sargramostim (3F8/GM-CSF) in patients with advanced neuroblastoma. Assess the biological effects of 3F8/GM-CSF in these patients. OUTLINE: Patients receive monoclonal antibody 3F8 IV over 1.5 hours on days 0-4 and 7-11 and sargramostim (GM-CSF) IV over 2 hours on days -5 to 11. Treatment is repeated every 4 weeks for up to 4 courses in the absence of progressive disease, HAMA response, or unacceptable toxicity. PROJECTED ACCRUAL: A total of 11-40 patients will be accrued for this study over 4 years.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.40 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 2 to 21 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
Criteria
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
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