Phase II Study of Anti-GD2 3F8 Antibody and Biologic Response Modifiers for High-risk Neuroblastoma
Data Collection
Neoplasms+7
+ Neoplasms by Histologic Type
+ Neoplasms, Germ Cell and Embryonal
Treatment Study
Summary
Study start date: July 1, 2004
Actual date on which the first participant was enrolled.OBJECTIVES: * Determine the efficacy of beta-glucan, isotretinoin, and sargramostim (GM-CSF) in enhancing monoclonal antibody 3F8-mediated ablation in patients with high-risk refractory neuroblastoma. * Determine the antitumor activity of this regimen, in terms of assessing disease status in the bone marrow by real-time quantitative reverse transcription polymerase chain reaction, in these patients. * Determine the toxicity of this regimen in these patients. OUTLINE: This is an open-label study. Patients are stratified according to refractory disease (primary refractory \[never had disease progression or disease recurrence\] vs secondary refractory \[recurrent disease that did not respond completely to reinduction therapy\]). * Courses 1 and 2: Patients receive sargramostim (GM-CSF) subcutaneously once daily on days -5 to 11. Patients also receive oral beta-glucan once daily on days -2 to 11 and monoclonal antibody (MOAB) 3F8 IV over 30-90 minutes on days 0-4 and 7-11. * Courses 3 and 4: Patients receive GM-CSF, beta-glucan, and MOAB 3F8 as above. Patients also receive oral isotretinoin twice daily on days -2 to 11. Treatment repeats every 2-4 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years. PROJECTED ACCRUAL: A total of 27-74 patients (10-33 for stratum 1 and 17-41 for stratum 2) will be accrued for this study.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.74 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.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
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