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Monoclonal Antibody Therapy Plus Etoposide in Treating Patients With Neuroblastoma Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Monoclonal Antibody Therapy Plus Etoposide in Treating Patients With Neuroblastoma conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Monoclonal Antibody Therapy Plus Etoposide in Treating Patients With Neuroblastoma Clinical research trials and Monoclonal Antibody Therapy Plus Etoposide in Treating Patients With Neuroblastoma health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Monoclonal Antibody Therapy Plus Etoposide in Treating Patients With Neuroblastoma. Monoclonal Antibody Therapy Plus Etoposide in Treating Patients With Neuroblastoma Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Monoclonal Antibody Therapy Plus Etoposide in Treating Patients With Neuroblastoma clinical trial. Participants oftentimes recieve the most expert healthcare available for their Monoclonal Antibody Therapy Plus Etoposide in Treating Patients With Neuroblastoma condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "M" Clinical Trials Conditions > Monoclonal Antibody Therapy Plus Etoposide in Treating Patients With Neuroblastoma  Monoclonal Antibody Therapy Plus Etoposide in Treating Patients With Neuroblastoma
Monoclonal Antibody Therapy Plus Etoposide in Treating Patients With Neuroblastoma
For Condition: disseminated neuroblastoma,regional neuroblastoma,localized unresectable neuroblastoma,recurrent neuroblastoma
Status: No longer recruiting
Sponsor(s): Memorial Sloan-Kettering Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody therapy plus etoposide in treating patients who have neuroblastoma.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
Nai-KongCheung, Study Chair, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Additional Information:
Study ID Numbers: CDR0000067333; MSKCC-IRB-99033,NCI-G99-1599
Study Start Date:
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004110
Other Recurrent Neuroblastoma Studies:
1. Monoclonal Antibody Therapy Plus Etoposide in Treating Patients With Neuroblastoma
2. Isotretinoin With or Without Monoclonal Antibody, Interleukin 2, and Sargramostim Following Stem Cell Transplantation in Treating Patients With Neuroblastoma
3. Multiple Therapies in Treating Patients With Advanced Neuroblastoma
4. Therapy Based on Stage of Disease and Risk Assessment in Treating Children With Neuroblastoma
5. Antineoplaston Therapy in Treating Patients With Metastatic, Recurrent, or Refractory Neuroblastoma
Related Studies:
Other recurrent neuroblastoma Clinical Trials
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Monoclonal Antibody Therapy Plus Etoposide in Treating Patients With Neuroblastoma
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