Monoclonal Antibody Therapy Plus Etoposide in Treating Patients With Neuroblastoma
|ClinicalTrials.gov Identifier: NCT00004110|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : October 31, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Neuroblastoma||Biological: monoclonal antibody 3F8 Drug: etoposide Drug: isotretinoin||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Masking:||None (Open Label)|
|Official Title:||Monoclonal Antibody 3F8 and Oral Etoposide for the Treatment of Neuroblastoma|
|Study Start Date :||August 1999|
|Primary Completion Date :||September 2004|
U.S. FDA Resources
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004110
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Nai-Kong V. Cheung, MD, PhD||Memorial Sloan Kettering Cancer Center|