NCT00087009

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for phase_1 leukemia

Timeline
Completed

Started May 2004

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2004

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 12, 2004

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

March 19, 2013

Status Verified

March 1, 2013

Enrollment Period

4.3 years

First QC Date

July 8, 2004

Last Update Submit

March 18, 2013

Conditions

LeukemiaLymphomaLymphoproliferative Disorder

Keywords

post-transplant lymphoproliferative disorderrecurrent childhood acute lymphoblastic leukemiarecurrent childhood large cell lymphomarecurrent childhood lymphoblastic lymphomarecurrent childhood small noncleaved cell lymphomarecurrent/refractory childhood Hodgkin lymphomaAIDS-related peripheral/systemic lymphomaAIDS-related primary CNS lymphoma

Outcome Measures

Primary Outcomes (1)

  • maximum tolerated dose

    2 years

Secondary Outcomes (1)

  • safety

    2 years

Study Arms (2)

Group I

EXPERIMENTAL

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-glucanBiological: rituximab

Group II

EXPERIMENTAL

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-glucanBiological: rituximab

Interventions

beta-glucanBIOLOGICAL

Given orally

Group IGroup II
rituximabBIOLOGICAL

Given IV

Group IGroup II

Eligibility Criteria

AgeUp to 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

LeukemiaLymphomaLymphoproliferative DisordersPrecursor Cell Lymphoblastic Leukemia-LymphomaDendritic Cell Sarcoma, InterdigitatingBurkitt LymphomaRecurrence

Interventions

beta-GlucansRituximab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, LymphoidHistiocytic Disorders, MalignantHistiocytosisEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellLymphoma, Non-HodgkinDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

GlucansPolysaccharidesCarbohydratesAntibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2004

First Posted

July 12, 2004

Study Start

May 1, 2004

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

March 19, 2013

Record last verified: 2013-03

Locations

US(1)