A Phase 1 interventional study of beta-glucan and rituximab in Leukemia, Lymphoma and Lymphoproliferative Disorder, sponsored by Memorial Sloan Kettering Cancer Center. Terminated at 1 site in United States. Open to participants aged Up to 21 Years. Per ClinicalTrials.gov, last updated 2013-03-19.
Sponsored by Memorial Sloan Kettering Cancer Center · Phase 1, Interventional, and Treatment
RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Beta-glucan may increase the effectiveness of rituximab by making cancer cells more sensitive to the monoclonal antibody.
PURPOSE: This phase I trial is studying the side effects and best dose of beta-glucan when given together with rituximab in treating young patients with relapsed or progressive lymphoma or leukemia or with lymphoproliferative disorder related to donor stem cell transplantation.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose-escalation study of beta-glucan. Patients are assigned to 1 of 2 treatment groups according to diagnosis.
Cohorts of 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 6 patients experience dose-limiting toxicity.
Patients are followed every 3 months for 2 years.
PROJECTED ACCRUAL: A total of 6-24 patients will be accrued for this study within 2 years.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 3 is below the median of 40 across 4,509 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,930 studies on the registry; 328 are open to participants now.
Of its 129 completed or terminated interventional studies of FDA-regulated products, 66 (51%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically confirmed diagnosis of 1 of the following:
Refractory to conventional therapy, defined as 1 of the following:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Immunologic
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Patients receive rituximab IV on days 1, 8, 15, and 22 and oral beta-glucan once daily on days 1-28 (days 8-28 of course 1). Treatment repeats every 42 days for 4 courses.
Biological: beta-glucan · Biological: rituximab
Patients receive rituximab IV on days 1, 4, 8, 15, and 22 and oral beta-glucan once daily on days 8-28. Beginning on day 42, patients with responding disease may receive monthly rituximab prophylaxis.
Biological: beta-glucan · Biological: rituximab
Given orally
Given IV
maximum tolerated dose
Time frame: 2 years
safety
Time frame: 2 years
This study is terminated, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.
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Memorial Sloan Kettering Cancer Center