Phase I Study of Oral ß-Glucan and Intravenous Rituximab Among Children and Adolescents With Relapsed CD20-Positive Lymphoma or Leukemia, or Post-Transplant Lymphoproliferative Disease
- 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.
- 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
- 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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
maximum tolerated dose
Shakeel Modak, MD
Memorial Sloan-Kettering Cancer Center
United States: Food and Drug Administration
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|