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NCT00089076 · REGISTRY CONDITION SEARCH

MDX-010 in Treating Patients With Recurrent or Refractory Lymphoma

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE1, PHASE2
Status at capture
TERMINATED
Registry last update
2014-05-30

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-010 and to see how well it works in treating patients with recurrent or refractory B-cell non-Hodgkin's lymphoma.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Overall Confirmed Responses(Complete Response or Partial Response)

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outcome · POSTED

Time to Progression (Phase 2)

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outcome · POSTED

Overall Survival (Phase 2)

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outcome · POSTED

Duration of Response (Phase 2)

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outcome · POSTED

Mean Change in % of CD3+CD4+ for Marker HLA-DR+

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outcome · POSTED

Mean Change in % of CD3+CD4- for Marker HLA-DR+

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outcome · POSTED

Mean Change in % of CD3+CD4+ for Marker CD45RO+

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outcome · POSTED

Mean Change in % of CD3+CD4- for the Marker CD45RO+

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    PHASE I: Patients receive MDX-010 IV over 90 minutes on day 1. Treatment repeats every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 6 patients from each group receive escalating doses of MDX-010 until the MTD is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. PHASE II: Patients receive MDX-010 as in phase I at the MTD.
    intervention Names
    1. Biological: ipilimumab
    2. Other: laboratory biomarker analysis
    label
    Treatment (ipilimumab)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Treatment (ipilimumab)
    description
    Given IV
    name
    ipilimumab
    other Names
    1. anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody
    2. MDX-010
    3. MDX-CTLA-4
    4. monoclonal antibody CTLA-4
    type
    BIOLOGICAL
  2. arm Group Labels
    1. Treatment (ipilimumab)
    description
    Correlative studies
    name
    laboratory biomarker analysis
    type
    OTHER
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
18
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Confirmed response is at least a 50% decrease in the sum of the products of the greatest diameters (SPD) of the six largest dominant nodes or nodal masses and no increase in the size of other nodes, liver, or spleen and splenic and hepatic nodules must regress by at least 50% in the SPD and no new sites of disease.
    measure
    Number of Overall Confirmed Responses(Complete Response or Partial Response)
    time Frame
    From registration to month 7
secondary Outcomes
  1. description
    The time to progression is defined as the time from registration to the time of progression. Those who die will be considered to have had disease progression unless documented evidence clearly indicates no progression has occurred. The distribution of time to progression will be estimated using the method of Kaplan-Meier.
    measure
    Time to Progression (Phase 2)
    time Frame
    From registration to progression (up to 2 years)
  2. description
    The overall survival or survival time is defined as the time from registration to death due to any cause. The distribution of overall survival will be estimated using the method of Kaplan-Meier.
    measure
    Overall Survival (Phase 2)
    time Frame
    From registration to death (up to 2 years)
  3. description
    Duration of response will be calculated from the documentation of confirmed response until the date of progression in the subset of patients who respond.
    measure
    Duration of Response (Phase 2)
    time Frame
    From response to progression (up to 2 years)
  4. description
    Flow cytometric analysis of T-cell surface markers before and 1 month after initiation therapy
    measure
    Mean Change in % of CD3+CD4+ for Marker HLA-DR+
    time Frame
    Before treatment to 1 month after therapy initiation
  5. description
    Flow cytometric analysis of T-cell surface markers before and 1 month after initiation therapy
    measure
    Mean Change in % of CD3+CD4- for Marker HLA-DR+
    time Frame
    Before treatment to 1 month after therapy initiation
  6. description
    Flow cytometric analysis of T-cell surface markers before and 1 month after initiation therapy
    measure
    Mean Change in % of CD3+CD4+ for Marker CD45RO+
    time Frame
    Before treatment to 1 month after therapy initiation
  7. description
    Flow cytometric analysis of T-cell surface markers before and 1 month after initiation therapy
    measure
    Mean Change in % of CD3+CD4- for the Marker CD45RO+
    time Frame
    Before treatment to 1 month after therapy initiation
Full study description
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-010 and to see how well it works in treating patients with recurrent or refractory B-cell non-Hodgkin's lymphoma.
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 evaluate the clinical response rate in B cell lymphoma patients treated with MDX-010. SECONDARY OBJECTIVES: I. To evaluate the phenotype and function of memory T cells before and after treatment with MDX-010 by: * Quantitation and phenotypic characterization of peripheral blood and tumor infiltrating T-cells, including cluster of differentiation (CD)4+CD25+ regulatory T cells. * Measurement of tumor-specific T cells in peripheral blood lymphocytes. * Measuring proliferation of memory T cells in response to recall antigens (tetanus toxoid and keyhole limpet hemocyanin \[KLH\]). II. Measurement of anti-tumor antibodies in serum pre- and post-therapy. III. To evaluate the time to progression. IV. To evaluate the duration of response to treatment with MDX-010. OUTLINE: This is a multicenter, open-label, phase I, dose-escalation study followed by a phase II study. Patients are grouped according to prior treatment with a vaccine therapy for lymphoma (yes vs no). PHASE I: Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on day 1. Treatment repeats every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 6 patients from each group receive escalating doses of MDX-010 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. PHASE II: Patients receive MDX-010 as in phase I at the MTD. Patients are followed at 1 and 4 months and then every 6 months for up to 2 years.
Source references
Source notices and limitations
    Discovery and provenance
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    Preserved source evidence · Not medical advice