Status:
TERMINATED
MDX-010 in Treating Patients With Recurrent or Refractory Lymphoma
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Adult Grade III Lymphomatoid Granulomatosis
B-cell Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Biological therapies, such as MDX-010, work in different ways to stimulate the immune system and stop cancer cells from growing. This phase I/II trial is studying the side effects and best dose of MDX...
Detailed Description
PRIMARY OBJECTIVES: I. To characterize the safety profile of MDX-010 (ipilimumab) monoclonal antibody and identify a tolerable immunologically active dose level in B cell lymphoma patients. II. To e...
Eligibility Criteria
Inclusion
- Histologic proof of recurring or residual follicular B-cell non-Hodgkin's lymphoma (grade I or II), by Revised European American Lymphoma Classification (REAL) or World Health Organization (WHO) classifications which has relapsed or persisted after 3 or fewer conventional therapies, including chemotherapy or monoclonal antibody therapy; note: all patients with previously treated B-cell lymphomas of any histology with the exception of small lymphocytic lymphoma/chronic lymphocytic leukemia (CLL) are eligible
- Tumor measurable by computed tomography (CT) scans (at least one pathologic node measuring 2.0 x 2.0 cm, or 2 nodes measuring \> 1.5 x 1.5 cm after collection of tumor for immunologic analyses)
- At least one prior treatment regimen but no more than 3 prior chemotherapy regimens; patients previously treated with monoclonal antibodies or radiotherapy to a single site will be eligible; these therapies will be considered prior treatment regimens but will not be considered as prior chemotherapy; tumor vaccines will not be counted as prior therapies, as all such agents are investigational
- Absolute neutrophil count (ANC) \>= 1000/uL
- Platelets (PLT) \>= 75,000/uL
- Total bilirubin =\< 1.5 x upper limit of normal (ULN)
- Aspartate aminotransferase (AST) =\< 3 x upper limit or normal (ULN)
- Creatinine =\< 1.5 x ULN
- Hemoglobin \>= 8 g/dL
- Ability to provide informed consent
- Willingness to return to the Mayo Clinic Rochester or the University of California, Los Angeles for follow up
- Life expectancy \>= 24 weeks
- Willingness to provide all biologic specimens as required by the protocol
Exclusion
- Known standard therapy for the patient's disease that is potentially curative or definitely capable of extending life expectancy
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 2, 3, or 4
- Any uncontrolled infection, hepatitis C virus (HCV)+ (unless HCV ribonucleic acid \[RNA\]-negative by polymerase chain reaction \[PCR\]) or hepatitis B surface antigen (HBsAg)+, or human immunodeficiency virus (HIV) positive patients or patients with known immune deficiency states
- Previous MDX-010 therapy regardless of interval since last treatment
- Prior treatment with fludarabine or 2-chlorodeoxyadenosine =\< 12 months prior to registration
- Failure to fully recover from acute, reversible effects of prior chemotherapy regardless of interval since last treatment
- New York Heart Association classification III or IV or a history of angina pectoris requiring active treatment
- Clinical evidence of central nervous system involvement by lymphoma
- Any of the following:
- Pregnant women
- Nursing women
- Men or women of childbearing potential who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device \[IUD\], or abstinence, etc.)
- Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (utilized for a non-Food and Drug Administration \[FDA\]-approved indication and in the context of a research investigation)
- Diagnosis of small lymphocytic lymphoma/chronic lymphocytic leukemia (CLL)
- Any requirement for concurrent steroid therapy, including use of inhaled steroids for asthma
- History of autoimmune disease requiring systemic therapy with immunosuppressive drugs, including but not limited to rheumatoid arthritis, inflammatory bowel disease, systemic lupus erythematosus, multiple sclerosis, or psoriasis
- Antinuclear antibody (ANA) titer or rheumatoid factor titer \> 3x institutional ULN
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00089076
Start Date
June 1 2004
End Date
October 1 2009
Last Update
May 30 2014
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905