beta-glucan and rituximab in treating young patients with relapsed or progressive lymphoma or leukemia, or lymphoproliferative disorder related to donor stem cell transplantation

Conditions: Leukemia; Lymphoma; Lymphoproliferative Disorder

Summary: 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 * 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.

Eligibility 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

Keywords: post-transplant lymphoproliferative disorder recurrent childhood acute lymphoblastic leukemia recurrent childhood large cell lymphoma recurrent childhood lymphoblastic lymphoma recurrent childhood small noncleaved cell lymphoma recurrent/refractory childhood hodgkin lymphoma aids-related peripheral/systemic lymphoma aids-related primary cns lymphoma