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Beta-Glucan and Rituximab in Treating Young Patients With Relapsed or Progressive Lymphoma or Leukemia, or Lymphoproliferative Disorder Related to Donor Stem Cell Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00087009
Recruitment Status : Terminated (Lack of Accrual)
First Posted : July 12, 2004
Last Update Posted : March 19, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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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.


Condition or disease Intervention/treatment Phase
Leukemia Lymphoma Lymphoproliferative Disorder Biological: beta-glucan Biological: rituximab Phase 1

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : May 2004
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia Lymphoma
Drug Information available for: Rituximab

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. maximum tolerated dose [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. safety [ Time Frame: 2 years ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00087009


Locations
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United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Investigators
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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
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00087009    
Other Study ID Numbers: 03-095
P30CA008748 ( U.S. NIH Grant/Contract )
MSKCC-03095
First Posted: July 12, 2004    Key Record Dates
Last Update Posted: March 19, 2013
Last Verified: March 2013
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:
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Lymphoma
Leukemia
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Neoplasms
Lymphatic Diseases
Immunoproliferative Disorders
 Immune System Diseases
Rituximab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents