CpG 7909, Rituximab, and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Non-Hodgkin's Lymphoma That is Recurrent or Did Not Respond to Previous Treatment

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Thomas E. Witzig, M.D., Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00438880
First received: February 20, 2007
Last updated: April 2, 2013
Last verified: April 2013
  Purpose

RATIONALE: Biological therapies, such as CpG 7909, may stimulate the immune system in different ways and stop cancer cells from growing. Monoclonal antibodies, such as rituximab and yttrium Y 90 ibritumomab tiuxetan, 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. Giving CpG 7909 together with monoclonal antibodies may kill more cancer cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of CpG 7909 when given together with rituximab and yttrium Y 90 ibritumomab tiuxetan and to see how well it works in treating patients with non-Hodgkin's lymphoma that is recurrent or did not respond to previous treatment.


Condition Intervention Phase
Lymphoma
Biological: rituximab
Drug: agatolimod sodium
Other: biomarker analysis
Other: flow cytometry
Other: immunologic technique
Other: laboratory biomarker analysis
Procedure: radionuclide imaging
Procedure: single photon emission computed tomography
Radiation: indium In 111 ibritumomab tiuxetan
Radiation: yttrium Y 90 ibritumomab tiuxetan
Phase 1
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase I/II Trial of CpG 7909, Rituximab Immunotherapy, and Y-90 Zevalin Radioimmunotherapy for Patients With Previously Treated CD20+ Non-Hodgkin Lymphoma

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Toxicity [ Designated as safety issue: Yes ]
  • Immunostimulation (optimal immunological dose) [ Designated as safety issue: No ]
  • Change in fraction of injected activity [ Designated as safety issue: No ]
  • Tumor response [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response rate (complete response [CR], CR unconfirmed, partial response) [ Designated as safety issue: No ]
  • Human antimouse antibodies and human antichimeric antibodies [ Designated as safety issue: No ]
  • Event-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Duration of response [ Designated as safety issue: No ]

Estimated Enrollment: 63
Study Start Date: October 2004
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed non-Hodgkin's lymphoma, including the following subtypes:

    • Small lymphocytic lymphoma*
    • Lymphoplasmacytoid lymphoma*
    • Grade 1, 2, or 3 follicular lymphoma*
    • Extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue*
    • Nodal marginal zone B-cell lymphoma*
    • Splenic marginal zone B-cell lymphoma*
    • Mantle cell lymphoma*
    • Diffuse large cell lymphoma
    • Transformed lymphoma NOTE: *Closed to accrual as of 10/29/07
  • Recurrent, refractory, or residual disease
  • CD20-positive disease
  • Bidimensionally measurable disease (≥ 1 lesion that has a single diameter of ≥ 2 cm)
  • Must have < 25% bone marrow involvement of cellular marrow with lymphoma, as determined by bilateral bone marrow aspirate and biopsy
  • No marrow cellularity ≤ 15% (as determined on all bone marrow samples)
  • No prior failed stem cell collection
  • No CNS lymphoma
  • No lymphoma related to HIV or AIDS
  • No myelodysplastic syndromes or marrow chromosomal changes suggesting myelodysplasia

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Life expectancy ≥ 3 months
  • Absolute neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 150,000/mm³
  • Lymphocyte count < 5,000/mm³ (only for patients with small lymphocytic lymphoma)
  • Hemoglobin ≥ 8 g/dL
  • Total bilirubin ≤ 2 times upper limit of normal (ULN) OR direct bilirubin ≤ 1.5 times ULN
  • Creatinine ≤ 2 mg/dL
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No serious nonmalignant disease (e.g., active infection) or other condition that would preclude study participation
  • No other active primary malignancy
  • No known human antimouse antibodies or human antichimeric antibodies
  • No skin rash (e.g., Stevens-Johnson's syndrome or toxic epidermal necrolysis) after receiving rituximab
  • No pre-existing clinical autoimmune or antibody-mediated diseases*, including any of the following:

    • Systemic lupus erythematosus
    • Rheumatoid arthritis
    • Multiple sclerosis
    • Sjögren's syndrome
    • Autoimmune thrombocytopenia
  • NOTE: *If no clinical symptoms, but only previously detected antibodies, then not excluded.

PRIOR CONCURRENT THERAPY:

  • More than 1 week since prior filgrastim (G-CSF) or sargramostim (GM-CSF) (3 weeks for pegfilgrastim)
  • More than 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas or mitomycin C)
  • More than 4 weeks since prior major surgery, except for diagnostic surgery
  • More than 6 weeks since prior rituximab
  • No prior external-beam radiotherapy to > 25% of active bone marrow
  • No prior myeloablative therapies with autologous or allogeneic bone marrow transplantation or peripheral blood stem cell support
  • No prior radioimmunotherapy, including yttrium Y 90 ibritumomab tiuxetan, tositumomab, or iodine I 131 monoclonal antibody Lym-1
  • No concurrent myelosuppressive chemotherapy
  • No concurrent corticosteroid therapy, except prednisone (< 20 mg) for benign causes
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00438880

Locations
United States, Iowa
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States, 52242-1002
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Study Chair: Thomas E. Witzig, MD Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Thomas E. Witzig, M.D., Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00438880     History of Changes
Other Study ID Numbers: LS0382, LS0382, 703-04, LS0382
Study First Received: February 20, 2007
Last Updated: April 2, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Mayo Clinic:
recurrent adult diffuse large cell lymphoma
Waldenström macroglobulinemia
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
recurrent small lymphocytic lymphoma
recurrent mantle cell lymphoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
nodal marginal zone B-cell lymphoma
recurrent marginal zone lymphoma
splenic marginal zone lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 26, 2014