Agatolimod Sodium, Rituximab, and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Recurrent or Refractory Non-Hodgkin Lymphoma

Summary

RATIONALE: Biological therapies, such as agatolimod sodium, may stimulate the immune system in different ways and stop cancer cells from growing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Radiolabeled monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan, can find cancer cells and carry cancer-killing substances to them without harming normal cells. Giving agatolimod sodium together with rituximab and yttrium Y 90 ibritumomab tiuxetan may kill more cancer cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of agatolimod sodium when given together with rituximab and yttrium Y 90 ibritumomab tiuxetan and to see how well it works in treating patients with recurrent or refractory non-Hodgkin lymphoma.

Conditions

• Adult Non-Hodgkin Lymphoma
• Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue
• Nodal Marginal Zone Lymphoma
• Recurrent Adult Diffuse Large Cell Lymphoma
• Recurrent Grade 1 Follicular Lymphoma
• Recurrent Grade 2 Follicular Lymphoma
• Recurrent Grade 3 Follicular Lymphoma
• Recurrent Mantle Cell Lymphoma
• Recurrent Marginal Zone Lymphoma
• Recurrent Small Lymphocytic Lymphoma
• Splenic Marginal Zone Lymphoma
• Waldenstrom Macroglobulinemia

Interventions

DRUG

Agatolimod Sodium

Given IV

RADIATION

Indium In-111 Ibritumomab Tiuxetan

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative study

PROCEDURE

Radionuclide Imaging

Undergo imaging scans

BIOLOGICAL

Rituximab

Given IV

PROCEDURE

Single Photon Emission Computed Tomography

Undergo imaging scans

RADIATION

Yttrium Y-90 Ibritumomab Tiuxetan

Given IV

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Mayo Clinic

  lead OTHER

Principal Investigators

• Thomas Witzig · Mayo Clinic

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2004-10-31

Primary Completion

2010-10-31

Completion

2014-11-30

Countries

• United States

Study Locations