Beta-Glucan and Monoclonal Antibody 3F8 in Treating Patients With Metastatic Neuroblastoma
Recruitment status was Active, not recruiting
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First Received Date ICMJE | June 25, 2007 | ||||||||
Last Updated Date | July 22, 2009 | ||||||||
Start Date ICMJE | August 2005 | ||||||||
Estimated Primary Completion Date | August 2010 (final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Toxicity [ Designated as safety issue: Yes ] | ||||||||
Original Primary Outcome Measures ICMJE |
Toxicity | ||||||||
Change History | Complete list of historical versions of study NCT00492167 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures ICMJE | |||||||||
Original Secondary Outcome Measures ICMJE | |||||||||
Current Other Outcome Measures ICMJE | |||||||||
Original Other Outcome Measures ICMJE | |||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Beta-Glucan and Monoclonal Antibody 3F8 in Treating Patients With Metastatic Neuroblastoma | ||||||||
Official Title ICMJE | Phase I Study of Oral Yeast β-Glucan and Intravenous Anti-GD2 Monoclonal Antibody 3F8 Among Patients With Metastatic Neuroblastoma | ||||||||
Brief Summary | RATIONALE: Beta-glucan may stimulate the immune system and stop tumor cells from growing. Monoclonal antibodies, such as 3F8, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving beta-glucan together with monoclonal antibody 3F8 may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of beta-glucan when given together with monoclonal antibody 3F8 in treating patients with metastatic neuroblastoma. |
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Detailed Description | OBJECTIVES: Primary
OUTLINE: This is a dose-escalation study of beta-glucan. Patients receive oral beta-glucan once daily on days -4 to 12 and monoclonal antibody 3F8 IV over 30-90 minutes on days 1-5 and 8-12. Treatment repeats every 4 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity and with a human antimouse antibody (HAMA) titer < 1,000 U/mL. Cohorts of 3-6 patients receive escalating doses of beta-glucan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients undergo urine, bone marrow, and blood sample collection periodically for biological studies. Samples are analyzed for antibody-dependent cellular cytotoxicity, complement-mediated cytotoxicity, and serum HAMA response via immunohistochemistry. After completion of study treatment, patients are followed periodically. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase | Phase 1 | ||||||||
Study Design ICMJE | Primary Purpose: Treatment | ||||||||
Condition ICMJE | Neuroblastoma | ||||||||
Intervention ICMJE |
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Study Arm (s) | |||||||||
Publications * | |||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Active, not recruiting | ||||||||
Estimated Enrollment ICMJE | 42 | ||||||||
Completion Date | |||||||||
Estimated Primary Completion Date | August 2010 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Gender | Both | ||||||||
Ages | |||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
Location Countries ICMJE | United States | ||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT00492167 | ||||||||
Other Study ID Numbers ICMJE | CDR0000554434, MSKCC-05073 | ||||||||
Has Data Monitoring Committee | |||||||||
Responsible Party | |||||||||
Study Sponsor ICMJE | Memorial Sloan-Kettering Cancer Center | ||||||||
Collaborators ICMJE | National Cancer Institute (NCI) | ||||||||
Investigators ICMJE |
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Information Provided By | National Cancer Institute (NCI) | ||||||||
Verification Date | July 2009 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |