Expired Study
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New York, New York 10021


Purpose:

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.


Study summary:

OBJECTIVES: Primary - Determine the maximum tolerated dose of beta-glucan when given in combination with rituximab in pediatric patients with relapsed or progressive CD20-positive lymphoma or leukemia or post-allogeneic stem cell transplant-related lymphoproliferative disorder. - Determine the toxicity of this regimen, with special emphasis on the degree of B-cell depletion and immune suppression, in these patients. - Determine the effects of beta-glucan on leukocyte-mediated cytotoxic effects in patients treated with this regimen. Secondary - Determine the antitumor effect of this regimen in these patients. OUTLINE: This is a dose-escalation study of beta-glucan. Patients are assigned to 1 of 2 treatment groups according to diagnosis. - Group I (lymphoma or leukemia): 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 in the absence of disease progression or unacceptable toxicity. - Group II (post-allogeneic stem cell transplant-related lymphoproliferative disorder): 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 until their CD4 cell count is > 200/mm^3. 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.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed diagnosis of 1 of the following: - B-cell non-Hodgkin's lymphoma (NHL) - Hodgkin's lymphoma - Post-transplant lymphoproliferative disorder (PTLD) - Lymphoblastic leukemia - CD20-positive disease verified by immunophenotyping at original diagnosis, disease relapse, or disease progression - Refractory to conventional therapy, defined as 1 of the following: - Medically refractory HIV-associated NHL - Refractory or recurrent lymphoblastic leukemia - PTLD - In > first relapse or progression of B-cell NHL or Hodgkin's lymphoma - Measurable (CT scan or MRI) or evaluable (marrow metastases or circulating lymphoblasts) disease within 4 weeks after completion of prior systemic (including systemic steroids) therapy PATIENT CHARACTERISTICS: Age - Under 22 Performance status - Not specified Life expectancy - Not specified Hematopoietic - Absolute neutrophil count > 500/mm^3* - Platelet count > 10,000/mm^3* NOTE: *Excluding patients with PTLD or CD20-positive lymphoblastic leukemia Hepatic - Hepatic toxicity ≤ grade 2 Renal - Creatinine clearance ≥ 60 mL/min - Renal toxicity ≤ grade 2 Cardiovascular - Cardiac toxicity ≤ grade 2 Pulmonary - Pulmonary toxicity ≤ grade 2 Immunologic - Human anti-mouse antibody (HAMA) ≤ 1,000 units/mL - Human anti-chimeric antibody titer negative - No active, life-threatening infections except Epstein-Barr virus-associated lymphoproliferative disorder - No history of allergy to mouse proteins - No history of allergy to rituximab or other chimeric monoclonal antibodies - No history of allergy to beta-glucan or oats, barley, mushrooms, or yeast Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - Grade 3 hearing deficit allowed - Gastrointestinal toxicity ≤ grade 2 - Neurologic toxicity ≤ grade 2 - No severe major organ toxicity PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics - More than 4 weeks since prior rituximab - No prior mouse antibodies - No prior chimeric antibodies Chemotherapy - Not specified Endocrine therapy - See Disease Characteristics Radiotherapy - Not specified Surgery - Not specified


NCT ID:

NCT00087009


Primary Contact:

Principal Investigator
Shakeel Modak, MD
Memorial Sloan-Kettering Cancer Center


Backup Contact:

N/A


Location Contact:

New York, New York 10021
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 17, 2017

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