Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00087009
Status:
TERMINATED
Last Update Posted:
2013-03-19
First Post:
2004-07-08
Brief Title:
Beta-Glucan and Rituximab in Treating Young Patients With Relapsed or Progressive Lymphoma or Leukemia or Lymphoproliferative Disorder Related to Donor Stem Cell Transplantation
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
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
Status:
TERMINATED
Status Verified Date:
2013-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of Accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
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 200mm3
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
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 200mm3
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MSKCC-03095 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA008748 |
| P30CA008748 | NIH | None | None |