Beta-Glucan and Rituximab in Treating Young Patients With Relapsed or Progressive Lymphoma or Leukemia, or Lymphoproliferative Disorder Related to Donor Stem Cell Transplantation
This study has been terminated.
(Lack of Accrual)
Sponsor:
Memorial Sloan-Kettering Cancer Center
Collaborator:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00087009
First received: July 8, 2004
Last updated: March 18, 2013
Last verified: March 2013
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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.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia Lymphoma Lymphoproliferative Disorder |
Biological: beta-glucan Biological: rituximab |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Memorial Sloan-Kettering Cancer Center:
Primary Outcome Measures:
- maximum tolerated dose [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- safety [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
| Enrollment: | 3 |
| Study Start Date: | May 2004 |
| Study Completion Date: | August 2008 |
| Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group I
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.
|
Biological: beta-glucan
Given orally
Biological: rituximab
Given IV
|
|
Experimental: Group II
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.
|
Biological: beta-glucan
Given orally
Biological: rituximab
Given IV
|
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 > 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| Ages Eligible for Study: | up to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00087009
Locations
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
| Principal Investigator: | Shakeel Modak, MD | Memorial Sloan-Kettering Cancer Center |
| Principal Investigator: | Nai-Kong V. Cheung, MD, PhD | Memorial Sloan-Kettering Cancer Center |
| Principal Investigator: | Trudy N. Small, MD | Memorial Sloan-Kettering Cancer Center |
| Principal Investigator: | Tanya Trippett, MD | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00087009 History of Changes |
| Other Study ID Numbers: | 03-095, P30CA008748, MSKCC-03095 |
| Study First Received: | July 8, 2004 |
| Last Updated: | March 18, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Memorial Sloan-Kettering Cancer Center:
|
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 |
Additional relevant MeSH terms:
|
Leukemia Lymphoma Lymphoproliferative Disorders Neoplasms by Histologic Type Neoplasms Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
Rituximab Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 23, 2013