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

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Primary Purpose

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

beta-glucan

rituximab

About this trial

This is an interventional treatment trial for Leukemia focused on measuring 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

Eligibility Criteria

undefined - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Memorial Sloan-Kettering Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Group I

Group II

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

maximum tolerated dose

Secondary Outcome Measures

safety

Full Information

NCT ID

NCT00087009

First Posted

July 8, 2004

Last Updated

March 18, 2013

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00087009

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

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 Type

Interventional

2. Study Status

Record Verification Date

March 2013

Overall Recruitment Status

Terminated

Why Stopped

Lack of Accrual

Study Start Date

May 2004 (undefined)

Primary Completion Date

August 2008 (Actual)

Study Completion Date

August 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Leukemia, Lymphoma, Lymphoproliferative Disorder

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group I

Arm Type

Experimental

Arm Description

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.

Arm Title

Group II

Arm Type

Experimental

Arm Description

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.

Intervention Type

Biological

Intervention Name(s)

beta-glucan

Intervention Description

Given orally

Intervention Type

Biological

Intervention Name(s)

rituximab

Intervention Description

Given IV

Primary Outcome Measure Information:

Title

maximum tolerated dose

Time Frame

2 years

Secondary Outcome Measure Information:

Title

safety

Time Frame

2 years

10. Eligibility

Sex

All

Maximum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

No

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shakeel Modak, MD

Organizational Affiliation

Memorial Sloan Kettering Cancer Center

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Nai-Kong V. Cheung, MD, PhD

Organizational Affiliation

Memorial Sloan Kettering Cancer Center

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Trudy N. Small, MD

Organizational Affiliation

Memorial Sloan Kettering Cancer Center

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Tanya Trippett, MD

Organizational Affiliation

Memorial Sloan Kettering Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Memorial Sloan-Kettering Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

Leukemia, Lymphoma, Lymphoproliferative Disorder

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial