Beta-Glucan and Rituximab in Treating Young Patients With Relapsed or Progressive Lymphoma or Leu… (NCT00087009) | Clinical Trial Compass
TerminatedPhase 1
Beta-Glucan and Rituximab in Treating Young Patients With Relapsed or Progressive Lymphoma or Leukemia, or Lymphoproliferative Disorder Related to Donor Stem Cell Transplantation
Stopped: Lack of Accrual
United States3 participantsStarted 2004-05
Plain-language 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.
Who can participate
Age range21 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…