NCT00047164

Brief Summary

RATIONALE: Monoclonal antibodies such as anti-cytotoxic T-lymphocyte-associated antigen-4 can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. PURPOSE: This phase II trial is studying anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody to see how well it works in treating patients with lymphoma or colon cancer that has not responded to vaccine therapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P75+ for phase_1 lymphoma

Timeline
Completed

Started Sep 2002

Longer than P75 for phase_1 lymphoma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2002

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 3, 2002

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

September 26, 2016

Status Verified

March 1, 2012

Enrollment Period

8 years

First QC Date

October 3, 2002

Last Update Submit

September 23, 2016

Conditions

Lymphoma

Keywords

recurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomacontiguous stage II adult lymphoblastic lymphomanoncontiguous stage II adult lymphoblastic lymphomarecurrent adult lymphoblastic lymphomastage I adult lymphoblastic lymphomastage III adult lymphoblastic lymphomastage IV adult lymphoblastic lymphomanoncontiguous stage II grade 3 follicular lymphomarecurrent grade 3 follicular lymphomastage I grade 3 follicular lymphomastage III grade 3 follicular lymphomastage IV grade 3 follicular lymphomacontiguous stage II grade 3 follicular lymphomacontiguous stage II grade 2 follicular lymphomacontiguous stage II grade 1 follicular lymphomacontiguous stage II adult diffuse mixed cell lymphomanoncontiguous stage II adult diffuse mixed cell lymphomarecurrent adult diffuse mixed cell lymphomastage I adult diffuse mixed cell lymphomastage III adult diffuse mixed cell lymphomastage IV adult diffuse mixed cell lymphomacontiguous stage II adult diffuse large cell lymphomanoncontiguous stage II adult diffuse large cell lymphomarecurrent adult diffuse large cell lymphomastage I adult diffuse large cell lymphomastage III adult diffuse large cell lymphomastage IV adult diffuse large cell lymphomacontiguous stage II adult immunoblastic large cell lymphomanoncontiguous stage II adult immunoblastic large cell lymphomarecurrent adult immunoblastic large cell lymphomastage I adult immunoblastic large cell lymphomastage III adult immunoblastic large cell lymphomastage IV adult immunoblastic large cell lymphomacontiguous stage II adult Burkitt lymphomanoncontiguous stage II adult Burkitt lymphomarecurrent adult Burkitt lymphomastage I adult Burkitt lymphomastage III adult Burkitt lymphomastage IV adult Burkitt lymphomacontiguous stage II mantle cell lymphomanoncontiguous stage II mantle cell lymphomarecurrent mantle cell lymphomastage I mantle cell lymphomastage III mantle cell lymphomastage IV mantle cell lymphomarecurrent adult Hodgkin lymphomastage I adult Hodgkin lymphomastage II adult Hodgkin lymphomastage III adult Hodgkin lymphomastage IV adult Hodgkin lymphomarecurrent adult diffuse small cleaved cell lymphomastage I adult diffuse small cleaved cell lymphomastage II adult diffuse small cleaved cell lymphomastage III adult diffuse small cleaved cell lymphomastage IV adult diffuse small cleaved cell lymphomacontiguous stage II marginal zone lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomanoncontiguous stage II marginal zone lymphomarecurrent marginal zone lymphomasplenic marginal zone lymphomastage I marginal zone lymphomastage III marginal zone lymphomastage IV marginal zone lymphomacontiguous stage II small lymphocytic lymphomanoncontiguous stage II small lymphocytic lymphomarecurrent small lymphocytic lymphomastage I small lymphocytic lymphomastage III small lymphocytic lymphomastage IV small lymphocytic lymphomarecurrent adult T-cell leukemia/lymphomarecurrent cutaneous T-cell non-Hodgkin lymphomastage I adult T-cell leukemia/lymphomastage I cutaneous T-cell non-Hodgkin lymphomastage II adult T-cell leukemia/lymphomastage II cutaneous T-cell non-Hodgkin lymphomastage III adult T-cell leukemia/lymphomastage III cutaneous T-cell non-Hodgkin lymphomastage IV adult T-cell leukemia/lymphomastage IV cutaneous T-cell non-Hodgkin lymphoma

Outcome Measures

Primary Outcomes (1)

  • Toxicity after every 3 courses of treatment and every month for up to a year after completion of study treatment

Secondary Outcomes (1)

  • T-cell response after every 3 courses of treatment and every month for up to a year after completion of study treatment

Interventions

ipilimumabBIOLOGICAL

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed prostate cancer (closed to accrual as of 3/9/2005) * Prior therapy on protocol NCI-00-C-0137 or NCI-00-C-0154 * Progressive disease (2 consecutively rising PSA levels, new bone scan lesion, or progression of soft tissue) * PSA at least 5 ng/mL * Progressive androgen-independent disease * Disease progression at least 4 weeks after flutamide withdrawal OR * Disease progression at least 6 weeks after bicalutamide or nilutamide withdrawal OR * Histologically confirmed follicular or mantle cell non-Hodgkin's lymphoma (mantle cell lymphoma closed to accrual as of 3/9/2005) * Prior therapy on protocol NCI-00-C-0133, NCI-01-C-0169, or NCI-00-C-0050 * Progressive disease after standard treatment * Relapsed disease OR * Histologically confirmed colon cancer (colon cancer closed to accrual as of 9/28/05) * Prior therapy on protocol NCI-99-C-0023 * Progressive disease OR * Histologically confirmed non-Hodgkin's lymphoma or Hodgkin's lymphoma * Progressive disease after standard treatment * No curative therapy exists * Prior allogeneic stem cell transplantation from a matched sibling or matched unrelated donor for an aggressive lymphoma allowed * Last infusion of allogeneic cells (either hematopoietic stem cells or donor lymphocytes) must have occurred \> 90 days prior to study enrollment * No other standard therapy available or refused such therapy * No symptomatic or rapidly progressive malignancy requiring therapy * No symptomatic CNS metastases PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Karnofsky 80-100% Life expectancy * More than 2 months Hematopoietic * WBC at least 2,500/mm\^3 * Granulocyte count at least 1,500/mm\^3 * Platelet count at least 50,000/mm\^3 * Hemoglobin at least 10 g/dL * Hematocrit at least 30% Hepatic * Bilirubin no greater than 3.0 mg/dL (unless due to Gilbert's disease) * SGOT and SGPT no greater than 3 times upper limit of normal * Hepatitis B surface antigen negative * Hepatitis C antibody negative Renal * Creatinine no greater than 2.0 mg/dL Immunologic * HIV negative * Rheumatoid factor negative if history or evidence of arthritis * Anti-nuclear antibody (ANA) titer no greater than 1:80 if history or clinical signs or symptoms of connective tissue disease * No prior or active autoimmune disease (e.g., uveitis, rheumatoid arthritis, lupus erythematosus, autoimmune hemolytic anemia, ulcerative and hemorrhagic colitis, endocrine disorders \[e.g., thyroiditis, hyperthyroidism, hypothyroidism, autoimmune hypophysitis/hypopituitarism, or adrenal insufficiency\], sarcoid granuloma, myasthenia gravis, polymyositis,or Guillain-Barre syndrome) * No positive antibody titers to autoimmune diseases * Rheumatoid factor positive allowed unless ANA titer is greater than 1:80 and there is a history of or clinical signs or symptoms of connective tissue disease * No active infection Other * No other active malignancy within the past 5 years except adequately treated squamous cell or basal cell skin cancer, carcinoma in situ of the cervix, or superficial bladder cancer * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 4 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics * Recovered from prior vaccine therapy * No prior anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-CTLA4) for patients in part I of study * Patients in part II of study may have had up to 4 prior treatments with MDX-CTLA4 * No concurrent vaccine therapy * No concurrent infliximab Chemotherapy * At least 4 weeks since prior cytotoxic chemotherapy * No concurrent mercaptopurine, methotrexate, or cyclophosphamide Endocrine therapy * See Disease Characteristics * At least 4 weeks since prior steroids * No concurrent systemic, inhaled, or topical steroids Radiotherapy * At least 4 weeks since prior radiotherapy Surgery * At least 4 weeks since prior major surgery Other * Prior intervening therapy for prostate cancer, non-Hodgkin's lymphoma or colon cancer allowed * No other concurrent investigational therapy * No other concurrent immunosuppressants (e.g., cyclosporine or its analog)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

Bethesda, Maryland, 20892-1182, United States

Location

MeSH Terms

Conditions

LymphomaLymphoma, FollicularPrecursor Cell Lymphoblastic Leukemia-LymphomaLymphoma, Non-HodgkinLymphoma, Large B-Cell, DiffuseLymphoma, Large-Cell, ImmunoblasticBurkitt LymphomaLymphoma, Mantle-CellHodgkin DiseaseLymphoma, B-Cell, Marginal ZoneLeukemia, Lymphocytic, Chronic, B-CellPrecursor T-Cell Lymphoblastic Leukemia-LymphomaLymphoma, T-Cell, Cutaneous

Interventions

Ipilimumab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, LymphoidLeukemiaHematologic DiseasesLymphoma, B-CellEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLymphoma, T-Cell

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • John E. Janik, MD

    NCI - Metabolism Branch;MET

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

October 3, 2002

First Posted

January 27, 2003

Study Start

September 1, 2002

Primary Completion

September 1, 2010

Study Completion

November 1, 2010

Last Updated

September 26, 2016

Record last verified: 2012-03

Locations

US(1)