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

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
Mayo Clinic
Study ID
NCT00438880
Phase
PHASE1/PHASE2
Status
Completed

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Agatolimod Sodium — DRUG
    Given IV
  • Indium In-111 Ibritumomab Tiuxetan — RADIATION
    Given IV
  • Laboratory Biomarker Analysis — OTHER
    Correlative study
  • Radionuclide Imaging — PROCEDURE
    Undergo imaging scans
  • Rituximab — BIOLOGICAL
    Given IV
  • Single Photon Emission Computed Tomography — PROCEDURE
    Undergo imaging scans
  • Yttrium Y-90 Ibritumomab Tiuxetan — RADIATION
    Given IV

Study Details

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.

Key Dates

Start date
Oct 31, 2004
Status verified
Sep 2015
Primary completion
Oct 31, 2010
Completion
Nov 30, 2014

Study Design

Enrollment
38 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I
    See Detailed Description

Primary Outcome Measure

Maximum Tolerated Dose of CpG 7909 as Determined Using the Number of Participants With a DLT at Each Dose Level [ Time Frame: at least 10 weeks post treatment up to 3 months. ]

Locations (2)

FacilityCityStateZIPSite coordinators
University of Iowa/Holden Comprehensive Cancer CenterIowa CityIowa52242-
Mayo ClinicRochesterMinnesota55905-

Find similar trials in Iowa City, IA

By research site
University of Iowa/Holden Comprehensive Cancer Center· Iowa City, IAMayo Clinic· Rochester, MN

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