<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02210104</url>
  </required_header>
  <id_info>
    <org_study_id>2013-0669</org_study_id>
    <secondary_id>R01CA104711-09</secondary_id>
    <nct_id>NCT02210104</nct_id>
  </id_info>
  <brief_title>Adoptive Therapy Using Antigen-Specific CD4 T-Cells</brief_title>
  <official_title>Phase I Study of Cellular Adoptive Immunotherapy Using Autologous CD4+ NY-ESO-1-Specific T Cells and Anti-CTLA4 For Patients With NY-ESO-1-Expressing Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>M.D. Anderson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>M.D. Anderson Cancer Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this clinical research study is to learn about the safety of giving CD4+T cells&#xD;
      with ipilimumab and cyclophosphamide.&#xD;
&#xD;
      CD4+T cells are a type of white blood cell. Researchers grow the T cells in the laboratory,&#xD;
      and they are designed to find cancer cells and may kill them.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study Groups:&#xD;
&#xD;
      If you are found to be eligible to take part in this study, you will be assigned to a study&#xD;
      group based on when you join this study. The first 3 or 6 participants will receive a lower&#xD;
      dose of ipilimumab. If there are no intolerable side effects, then the second group of 6&#xD;
      participants will receive a higher dose of ipilimumab.&#xD;
&#xD;
      All study participants will receive the same dose level of cyclophosphamide and the CD4+T&#xD;
      cells.&#xD;
&#xD;
      Study Drug Administration:&#xD;
&#xD;
      You will receive cyclophosphamide by vein over about 30-60 minutes on Day -2 (2 days before&#xD;
      you receive the CD4+T cells). If the doctor thinks it is needed, you will be given standard&#xD;
      drugs to help decrease the risk of side effects. You may ask the study staff for information&#xD;
      about how the drugs are given and their risks.&#xD;
&#xD;
      On Day 0, you will receive the CD4+T cells by vein over about 30-60 minutes. You will stay in&#xD;
      the hospital overnight after the dose.&#xD;
&#xD;
      On Days 1, 22, 43, and 64, you will receive ipilimumab by vein over about 90 minutes.&#xD;
&#xD;
      Study Visits:&#xD;
&#xD;
      Within 2-4 weeks before you receive the CD4+T cells:&#xD;
&#xD;
        -  You will have a physical exam.&#xD;
&#xD;
        -  Blood (about 5½ tablespoons) will be drawn for routine tests, immune system tests, and&#xD;
           tests on how long the T-cells survive in your body.&#xD;
&#xD;
        -  You will have a computed tomography (CT) scan or x-rays to check the status of the&#xD;
           disease.&#xD;
&#xD;
      On Day -2:&#xD;
&#xD;
        -  You will have a physical exam.&#xD;
&#xD;
        -  Blood (about 1 tablespoon) will be drawn for routine tests. This routine blood draw will&#xD;
           include a pregnancy test if you can become pregnant.&#xD;
&#xD;
      On Day 1:&#xD;
&#xD;
        -  You will have a physical exam.&#xD;
&#xD;
        -  Blood (about 1 tablespoon) will be drawn for routine tests.&#xD;
&#xD;
      On Days 0, 7, 14, 22, 28, 35, 43, 49, and 56:&#xD;
&#xD;
        -  You will have a physical exam.&#xD;
&#xD;
        -  Blood (about 5½ tablespoons) will be drawn for routine tests, immune system tests, and&#xD;
           tests on how long the T-cells survive in your body.&#xD;
&#xD;
      On Day 3, blood (about 5½ tablespoons) will be drawn for routine tests, immune system tests,&#xD;
      and tests on how long the T-cells survive in your body.&#xD;
&#xD;
      Between Day 35 and 42 and again between Day 77 and 84, you will have a CT scan or x-rays to&#xD;
      check the status of the disease.&#xD;
&#xD;
      The study tests may be repeated or you may have additional tests performed anytime the doctor&#xD;
      thinks it is needed.&#xD;
&#xD;
      Some of the study tests may be done at your local clinic if you cannot return to MD Anderson.&#xD;
      The study staff will discuss this with you.&#xD;
&#xD;
      Length of Study Drug Dosing:&#xD;
&#xD;
      Your last study drug dose will be on Day 64. You will no longer be able to take the study&#xD;
      drugs if the disease gets worse, if intolerable side effects occur, or if you are unable to&#xD;
      follow study directions.&#xD;
&#xD;
      Your participation on the study will be over after the follow-up.&#xD;
&#xD;
      End-of-Study-Drug-Dosing Visit:&#xD;
&#xD;
      On Day 64:&#xD;
&#xD;
        -  You will have a physical exam.&#xD;
&#xD;
        -  Blood (about 5½ tablespoons) will be drawn for routine tests, immune system tests, and&#xD;
           tests on how long the T-cells survive in your body.&#xD;
&#xD;
      Follow-Up:&#xD;
&#xD;
      On Days 70, 77, 84, 105, 126, 147, and 168:&#xD;
&#xD;
        -  You will have a physical exam.&#xD;
&#xD;
        -  Blood (about 5½ tablespoons) will be drawn for routine tests, immune system tests, and&#xD;
           tests on how long the T-cells survive in your body.&#xD;
&#xD;
      Every 3 months after Day 84, unless the disease gets worse or you start another cancer&#xD;
      therapy, you will have a CT scan or x-rays to check the status of the disease. Every 3 months&#xD;
      for up to 5 years, the study staff will call you or ask your doctor how you are doing. If you&#xD;
      are called, the calls should last about 10-15 minutes.&#xD;
&#xD;
      If the doctor thinks it is needed to confirm the status of the disease, blood (about 1½&#xD;
      tablespoons) will be drawn every 3 months for up to 1 year.&#xD;
&#xD;
      If the doctor thinks it is needed, you will return to the clinic every 4-6 weeks starting&#xD;
      after Day 168 or as often as the doctor thinks is needed. These visits will stop if the&#xD;
      T-cells disappear or if the disease gets worse. Blood (about 5½ tablespoons) will be drawn&#xD;
      for routine tests, immune system tests, and tests on how long the T-cells survive in your&#xD;
      body.&#xD;
&#xD;
      This is an investigational study. CD4+T cells are not FDA approved or commercially available.&#xD;
      They are currently being used for research purposes only. Cyclophosphamide is FDA approved&#xD;
      and commercially available for the way it is being used in this study. Ipilimumab is FDA&#xD;
      approved and commercially available for the treatment of melanoma, but not for sarcoma. The&#xD;
      study doctor can explain how the study drugs are designed to work.&#xD;
&#xD;
      Up to 12 participants will be enrolled in this study. All will take part at MD Anderson.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Issues with tetramer staining&#xD;
  </why_stopped>
  <start_date>December 2016</start_date>
  <primary_completion_date type="Anticipated">December 2019</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum Tolerated Dose (MTD) of Adoptively Transferred CD4 T Cells</measure>
    <time_frame>12 weeks after T cell infusion</time_frame>
    <description>(MTD) defined as dose level below that at which excessive toxicity was observed. Dose limiting toxicity: Any ≥ Grade 2 eye pain or reduction of visual acuity that does not respond to topical therapy and does not improve to ≤ Grade 1 severity within 2 weeks of starting therapy requires systemic treatment; Any ≥ Grade 3 bronchospasm or other hypersensitivity reaction; Any adverse event, laboratory abnormality or intercurrent illness which, in the judgment of the Investigator, presents a substantial clinical risk to the patient with continued dosing; Any other ≥ Grade 3 non-skin related adverse event.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical Response</measure>
    <time_frame>6 weeks after T cell infusion</time_frame>
    <description>Complete response (CR) defined as total regression of all tumors, a partial response (PR) as 30% or greater decrease in the sum of the longest diameter of target lesions and progressive disease (PD) as 20% increase in the sum of the longest diameter of target lesions (modified world health organization criteria or mWHO. Radiographic imaging (as clinically indicated) and clinical assessment of residual disease compared with pre-infusion assessment.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Melanoma</condition>
  <condition>Sarcoma</condition>
  <arm_group>
    <arm_group_label>Ipilimumab + Cyclophosphamide + CD4+T Cells</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Starting Dose of Ipilimumab 1.0 mg /kg by vein on Days 1, 22, 43, and 64. Cyclophosphamide 300 mg/m2 administered intravenously 2 days prior to T cell infusion as an outpatient procedure. Antigen-specific CD4+ T cells administered at a dose 10^10 cells/m^2.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ipilimumab</intervention_name>
    <description>Starting Dose of Ipilimumab: 1.0 mg /kg by vein on Days 1, 22, 43, and 64.</description>
    <arm_group_label>Ipilimumab + Cyclophosphamide + CD4+T Cells</arm_group_label>
    <other_name>Yervoy</other_name>
    <other_name>BMS-734016</other_name>
    <other_name>MDX010</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cyclophosphamide</intervention_name>
    <description>300 mg/m2 administered intravenously 2 days prior to T cell infusion.</description>
    <arm_group_label>Ipilimumab + Cyclophosphamide + CD4+T Cells</arm_group_label>
    <other_name>Cytoxan</other_name>
    <other_name>Neosar</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>CD4+ T cells</intervention_name>
    <description>Antigen-specific CD4+ T cells administered at a dose of 10^10 cells/m^2 on Day 0.</description>
    <arm_group_label>Ipilimumab + Cyclophosphamide + CD4+T Cells</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Histopathologic documentation of melanoma, synovial sarcoma or mixed round cell&#xD;
             liposarcoma concurrent with the diagnosis of metastatic disease.&#xD;
&#xD;
          2. Tumor expression of NY-ESO-1 (2+ staining or &gt; 25%) by IHC.&#xD;
&#xD;
          3. Male or female subjects ≥18 years of age.&#xD;
&#xD;
          4. Expression of HLA-DPB1*0401&#xD;
&#xD;
          5. Eastern Cooperative Oncology Group (ECOG)/ Zubrod performance status of '0-1' .&#xD;
&#xD;
          6. Women of childbearing potential (WOCBP) must be using an adequate method of&#xD;
             contraception to avoid pregnancy throughout the study in such a manner that the risk&#xD;
             of pregnancy is minimized. Suggested precautions should be used to minimize the risk&#xD;
             or pregnancy for at least 1 month before start of therapy, and while women are on&#xD;
             study for up to 3 months after T cell infusion, and at least 8 weeks after the study&#xD;
             drug is stopped. WOCBP include any female who has experienced menarche and who has not&#xD;
             undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or&#xD;
             bilateral oophorectomy) or is not postmenopausal&#xD;
&#xD;
          7. Men must be willing and able to use an acceptable method of birth control, for at&#xD;
             least 3 months after completion of the study, if their sexual partners are WOCBP.&#xD;
&#xD;
          8. Willing and able to give informed consent.&#xD;
&#xD;
          9. Adequate venous access - consider peripherally inserted central venous catheter (PICC)&#xD;
             or central line&#xD;
&#xD;
         10. Bi-dimensionally measurable disease by palpation on clinical exam, or radiographic&#xD;
             imaging (X-ray or CT scan)&#xD;
&#xD;
         11. At least 4 weeks must have elapsed since the last chemotherapy, immunotherapy,&#xD;
             radiotherapy, or major surgery.&#xD;
&#xD;
         12. At least 6 weeks must have elapsed since the last nitrosoureas, mitomycin C and&#xD;
             liposomal doxorubicin&#xD;
&#xD;
         13. Toxicity related to prior therapy must either have returned to &lt; or equal to grade 1,&#xD;
             baseline, or been deemed irreversible&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with active infections or oral temperature &gt; 38.2 C within 71 hours of&#xD;
             Leukapheresis. The procedure may be deferred.&#xD;
&#xD;
          2. Patients with Hct &lt;30%, white blood count (WBC) &lt;2500/uL and platelets &lt;50,000&#xD;
             immediately prior to Leukapheresis. The procedure may be deferred.&#xD;
&#xD;
          3. Any other malignancy from which the patient has been disease-free for less than 5&#xD;
             years, with the exception of adequately treated and cured basal or squamous cell skin&#xD;
             cancer, superficial bladder cancer, carcinoma in situ of the cervix.&#xD;
&#xD;
          4. Complete blood count (CBC) and Chemistry profile prior to cyclophosphamide and T cell&#xD;
             infusions: WBC &lt; 2000/uL Hct &lt; 24% or Hb &lt; 8 g/dL absolute neutrophil count (ANC) &lt;&#xD;
             1000 Platelets &lt; 50,000 Creatinine &gt; 3.0 x ULN AST/ALT &gt; 2.5 x ULN Bilirubin &gt; 3 x ULN&#xD;
&#xD;
          5. Pregnant women, nursing mothers, men or women of reproductive ability who are&#xD;
             unwilling to use effective contraception. Women of childbearing potential with a&#xD;
             positive pregnancy test within 3 days prior to entry.&#xD;
&#xD;
          6. Clinically significant pulmonary dysfunction, as determined by medical history and&#xD;
             physical exam. Patients so identified will undergo pulmonary functions testing and&#xD;
             those with FEV1 &lt; 2.0 L or DLco (corr for Hgb) &lt; 75% will be excluded.&#xD;
&#xD;
          7. Significant cardiovascular abnormalities as defined by any one of the following:&#xD;
             Congestive heart failure, Clinically significant hypotension, Symptoms of coronary&#xD;
             artery disease, Presence of cardiac arrhythmias on EKG requiring drug therapy,Ejection&#xD;
             fraction &lt; 50 % (echocardiogram or MUGA).&#xD;
&#xD;
          8. Active and untreated central nervous system (CNS) metastasis (including metastasis&#xD;
             identified during screening MRI or contrast CT).&#xD;
&#xD;
          9. Autoimmune disease: Patients with a history of Inflammatory Bowel Disease are excluded&#xD;
             from this study, as are patients with a history of autoimmune disease (e.g. Systemic&#xD;
             Lupus Erythematosus, vasculitis, infiltrating lung disease) whose possible progression&#xD;
             during treatment would be considered by the Investigator to be unacceptable.&#xD;
&#xD;
         10. Any underlying medical or psychiatric condition, which in the opinion of the&#xD;
             Investigator, will make the administration of study drug hazardous or obscure the&#xD;
             interpretation of adverse events, such as a condition associated with frequent&#xD;
             diarrhea.&#xD;
&#xD;
         11. Positive screening tests for HIV, Hep B, and Hep C. If positive results are not&#xD;
             indicative of true active or chronic infection, the patient can be treated.&#xD;
&#xD;
         12. Steroids are not permitted 3 days prior to T cell infusion and concurrently during&#xD;
             therapy.&#xD;
&#xD;
         13. Any non-oncology vaccine therapy used for the prevention of infectious disease within&#xD;
             1 month before or after any ipilimumab dose.&#xD;
&#xD;
         14. No prisoners or children will be enrolled on this study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cassian Yee, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>M.D. Anderson Cancer Center</affiliation>
  </overall_official>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <link>
    <url>http://www.mdanderson.org</url>
    <description>University of Texas MD Anderson Cancer Center Website</description>
  </link>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>August 4, 2014</study_first_submitted>
  <study_first_submitted_qc>August 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 6, 2014</study_first_posted>
  <last_update_submitted>July 17, 2017</last_update_submitted>
  <last_update_submitted_qc>July 17, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Melanoma</keyword>
  <keyword>Sarcoma</keyword>
  <keyword>Mixed round cell liposarcoma</keyword>
  <keyword>Advanced</keyword>
  <keyword>Metastatic</keyword>
  <keyword>Immunotherapy</keyword>
  <keyword>Ipilimumab</keyword>
  <keyword>Yervoy</keyword>
  <keyword>BMS-734016</keyword>
  <keyword>MDX010</keyword>
  <keyword>Cyclophosphamide</keyword>
  <keyword>Cytoxan</keyword>
  <keyword>Neosar</keyword>
  <keyword>CD4+T Cells</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Melanoma</mesh_term>
    <mesh_term>Sarcoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cyclophosphamide</mesh_term>
    <mesh_term>Ipilimumab</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02210104
org study id: 2013-0669
secondary id: R01CA104711-09
nct id: NCT02210104
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The goal of this clinical research study is to learn about the safety of giving CD4+T cells
      with ipilimumab and cyclophosphamide.

      CD4+T cells are a type of white blood cell. Researchers grow the T cells in the laboratory,
      and they are designed to find cancer cells and may kill them.
Study Groups:

      If you are found to be eligible to take part in this study, you will be assigned to a study
      group based on when you join this study. The first 3 or 6 participants will receive a lower
      dose of ipilimumab. If there are no intolerable side effects, then the second group of 6
      participants will receive a higher dose of ipilimumab.

      All study participants will receive the same dose level of cyclophosphamide and the CD4+T
      cells.

      Study Drug Administration:

      You will receive cyclophosphamide by vein over about 30-60 minutes on Day -2 (2 days before
      you receive the CD4+T cells). If the doctor thinks it is needed, you will be given standard
      drugs to help decrease the risk of side effects. You may ask the study staff for information
      about how the drugs are given and their risks.

      On Day 0, you will receive the CD4+T cells by vein over about 30-60 minutes. You will stay in
      the hospital overnight after the dose.

      On Days 1, 22, 43, and 64, you will receive ipilimumab by vein over about 90 minutes.

      Study Visits:

      Within 2-4 weeks before you receive the CD4+T cells:

        -  You will have a physical exam.

        -  Blood (about 5½ tablespoons) will be drawn for routine tests, immune system tests, and
           tests on how long the T-cells survive in your body.

        -  You will have a computed tomography (CT) scan or x-rays to check the status of the
           disease.

      On Day -2:

        -  You will have a physical exam.

        -  Blood (about 1 tablespoon) will be drawn for routine tests. This routine blood draw will
           include a pregnancy test if you can become pregnant.

      On Day 1:

        -  You will have a physical exam.

        -  Blood (about 1 tablespoon) will be drawn for routine tests.

      On Days 0, 7, 14, 22, 28, 35, 43, 49, and 56:

        -  You will have a physical exam.

        -  Blood (about 5½ tablespoons) will be drawn for routine tests, immune system tests, and
           tests on how long the T-cells survive in your body.

      On Day 3, blood (about 5½ tablespoons) will be drawn for routine tests, immune system tests,
      and tests on how long the T-cells survive in your body.

      Between Day 35 and 42 and again between Day 77 and 84, you will have a CT scan or x-rays to
      check the status of the disease.

      The study tests may be repeated or you may have additional tests performed anytime the doctor
      thinks it is needed.

      Some of the study tests may be done at your local clinic if you cannot return to MD Anderson.
      The study staff will discuss this with you.

      Length of Study Drug Dosing:

      Your last study drug dose will be on Day 64. You will no longer be able to take the study
      drugs if the disease gets worse, if intolerable side effects occur, or if you are unable to
      follow study directions.

      Your participation on the study will be over after the follow-up.

      End-of-Study-Drug-Dosing Visit:

      On Day 64:

        -  You will have a physical exam.

        -  Blood (about 5½ tablespoons) will be drawn for routine tests, immune system tests, and
           tests on how long the T-cells survive in your body.

      Follow-Up:

      On Days 70, 77, 84, 105, 126, 147, and 168:

        -  You will have a physical exam.

        -  Blood (about 5½ tablespoons) will be drawn for routine tests, immune system tests, and
           tests on how long the T-cells survive in your body.

      Every 3 months after Day 84, unless the disease gets worse or you start another cancer
      therapy, you will have a CT scan or x-rays to check the status of the disease. Every 3 months
      for up to 5 years, the study staff will call you or ask your doctor how you are doing. If you
      are called, the calls should last about 10-15 minutes.

      If the doctor thinks it is needed to confirm the status of the disease, blood (about 1½
      tablespoons) will be drawn every 3 months for up to 1 year.

      If the doctor thinks it is needed, you will return to the clinic every 4-6 weeks starting
      after Day 168 or as often as the doctor thinks is needed. These visits will stop if the
      T-cells disappear or if the disease gets worse. Blood (about 5½ tablespoons) will be drawn
      for routine tests, immune system tests, and tests on how long the T-cells survive in your
      body.

      This is an investigational study. CD4+T cells are not FDA approved or commercially available.
      They are currently being used for research purposes only. Cyclophosphamide is FDA approved
      and commercially available for the way it is being used in this study. Ipilimumab is FDA
      approved and commercially available for the treatment of melanoma, but not for sarcoma. The
      study doctor can explain how the study drugs are designed to work.

      Up to 12 participants will be enrolled in this study. All will take part at MD Anderson.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum Tolerated Dose (MTD) of Adoptively Transferred CD4 T Cells
time frame: 12 weeks after T cell infusion
description: (MTD) defined as dose level below that at which excessive toxicity was observed. Dose limiting toxicity: Any ≥ Grade 2 eye pain or reduction of visual acuity that does not respond to topical therapy and does not improve to ≤ Grade 1 severity within 2 weeks of starting therapy requires systemic treatment; Any ≥ Grade 3 bronchospasm or other hypersensitivity reaction; Any adverse event, laboratory abnormality or intercurrent illness which, in the judgment of the Investigator, presents a substantial clinical risk to the patient with continued dosing; Any other ≥ Grade 3 non-skin related adverse event.
measure: Clinical Response
time frame: 6 weeks after T cell infusion
description: Complete response (CR) defined as total regression of all tumors, a partial response (PR) as 30% or greater decrease in the sum of the longest diameter of target lesions and progressive disease (PD) as 20% increase in the sum of the longest diameter of target lesions (modified world health organization criteria or mWHO. Radiographic imaging (as clinically indicated) and clinical assessment of residual disease compared with pre-infusion assessment.
arm group label: Ipilimumab + Cyclophosphamide + CD4+T Cells
arm group type: Experimental
description: Starting Dose of Ipilimumab 1.0 mg /kg by vein on Days 1, 22, 43, and 64. Cyclophosphamide 300 mg/m2 administered intravenously 2 days prior to T cell infusion as an outpatient procedure. Antigen-specific CD4+ T cells administered at a dose 10^10 cells/m^2.
intervention type: Drug
intervention name: Ipilimumab
description: Starting Dose of Ipilimumab: 1.0 mg /kg by vein on Days 1, 22, 43, and 64.
arm group label: Ipilimumab + Cyclophosphamide + CD4+T Cells
other name: Yervoy
other name: BMS-734016
other name: MDX010
intervention type: Drug
intervention name: Cyclophosphamide
description: 300 mg/m2 administered intravenously 2 days prior to T cell infusion.
arm group label: Ipilimumab + Cyclophosphamide + CD4+T Cells
other name: Cytoxan
other name: Neosar
intervention type: Biological
intervention name: CD4+ T cells
description: Antigen-specific CD4+ T cells administered at a dose of 10^10 cells/m^2 on Day 0.
arm group label: Ipilimumab + Cyclophosphamide + CD4+T Cells
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Cassian Yee, MD
role: Principal Investigator
affiliation: M.D. Anderson Cancer Center
country: United States
url: http://www.mdanderson.org
description: University of Texas MD Anderson Cancer Center Website
responsible party type: Sponsor
mesh term: Melanoma
mesh term: Sarcoma
mesh term: Cyclophosphamide
mesh term: Ipilimumab