Monoclonal Antibody 3F8 and Oral Etoposide for the Treatment of Neuroblastoma
monoclonal antibody 3F8
+ etoposide
+ isotretinoin
Neoplasms+7
+ Neoplasms by Histologic Type
+ Neoplasms, Germ Cell and Embryonal
Treatment Study
Summary
Study start date: August 1, 1999
Actual date on which the first participant was enrolled.OBJECTIVES: Determine the antitumor effects of monoclonal antibody 3F8, etoposide, and isotretinoin using standard imaging methods and tumor marker studies in patients with high-risk neuroblastoma. Assess progression-free survival in these patients after this treatment. Assess the effects of oral etoposide on human anti-mouse antibody and anti-idiotype response in these patients. OUTLINE: Patients are stratified according to disease status (evaluable but not measurable vs second or subsequent remission with no measurable or evaluable disease). Patients receive monoclonal antibody 3F8 (MOAB 3F8) IV over 1.5 hours once daily on days 1-10 and oral etoposide once daily on days 29-49. Treatment repeats every 8 weeks for 4 courses in the absence of disease progression, human anti-mouse antibody (HAMA) response, or unacceptable toxicity. If HAMA fails to develop after completion of 4 courses of MOAB 3F8, patients continue treatment with MOAB 3F8 on days 1-5 every 8 weeks until HAMA reaches greater than 1,000 U/mL or until month 24, whichever occurs first. Beginning after completion of 4 courses of etoposide and MOAB 3F8 or if HAMA develops, patients receive oral isotretinoin twice daily for 14 days followed by at least a 14-day rest. Treatment repeats for a total of 6 courses. PROJECTED ACCRUAL: A total of 50 patients (25 per stratum) will be accrued for this study within 5 years.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.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.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
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