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
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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 |
- 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 ]
- 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 |
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| 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 | |
| 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 June 17, 2013