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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 currently recruiting participants.
Verified by National Cancer Institute (NCI), September 2009
First Received: February 20, 2007   Last Updated: October 6, 2009   History of Changes
Sponsor: Mayo Clinic
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00438880
  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 I
Phase II

Study Type: Interventional
Study Design: 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 National Cancer Institute (NCI):

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
Estimated Primary Completion Date: November 2007 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00438880

Locations
United States, Iowa
Holden Comprehensive Cancer Center at University of Iowa Recruiting
Iowa City, Iowa, United States, 52242-1002
Contact: Cancer Information Service     800-237-1225        
United States, Minnesota
Mayo Clinic Cancer Center Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Office - All Mayo Clinic Locations     507-538-7623        
Sponsors and Collaborators
Mayo Clinic
Investigators
Study Chair: Thomas E. Witzig, MD Mayo Clinic
Investigator: Gregory Wiseman, MD Mayo Clinic
Investigator: George J. Weiner, MD Holden Comprehensive Cancer Center
Investigator: Stephen M. Ansell, MD, PhD Mayo Clinic
Investigator: Joseph P. Colgan, MD Mayo Clinic
Investigator: Thomas M. Habermann, MD Mayo Clinic
Investigator: David J. Inwards, MD Mayo Clinic
Investigator: Patrick Johnston, MD, PhD Mayo Clinic
Investigator: Paul Kurtin, MD Mayo Clinic
Investigator: Svetomir Markovic, MD, PhD Mayo Clinic
Investigator: Luis F. Porrata, MD Mayo Clinic
Investigator: William L. White, MD Mayo Clinic
Investigator: Ivana Micallef, MD Mayo Clinic
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000530062, MAYO-LS0382, MAYO-IRB-703-04
Study First Received: February 20, 2007
Last Updated: October 6, 2009
ClinicalTrials.gov Identifier: NCT00438880     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
recurrent adult diffuse large cell lymphoma
Waldenstrom 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:
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Immunologic Factors
Antineoplastic Agents
Rituximab
Physiological Effects of Drugs
Pharmacologic Actions
Antibodies, Monoclonal
Lymphatic Diseases
Neoplasms
Therapeutic Uses
Antirheumatic Agents
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma

ClinicalTrials.gov processed this record on February 08, 2010