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Melanoma

Phase I/II CD8+ NY-ESO-1 (FHCRC 2225)
Phase I/II Study of Cellular Adoptive Immunotherapy Using Autologous CD8+ NY-ESO-1-Specific T Cell Clones and Anti-CTLA4 for Patients With Metastatic Melanoma
Status Conditions Phase Study ID
Closed Melanoma (Skin) Phase I/II FHCRC 2225
NCT00871481
Summary

RATIONALE: Treating a patient's T cells in the laboratory may help the T cells kill more tumor cells when they are put back in the body. Monoclonal antibodies, such as ipilimumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving laboratory-treated T cells together with ipilimumab may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects of laboratory-treated T cells when given with or without ipilimumab and to see how well they work in treating patients with metastatic melanoma.


Investigator
Aude Chapuis, MD
Location    
FHCRC T-Cell Program 206-667-1539  
Eligibility Criteria (must meet the following to participate in this study)
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed melanoma

    • Metastatic disease
  • Tumor expression of NY-ESO-1 antigen (2+ staining or > 25%) by IHC
  • Bidimensionally measurable disease by palpation on clinical exam or by radiographic imaging (i.e., x-ray or CT scan)
  • Expression of HLA-A2
  • No active or untreated CNS metastasis (including metastasis identified during screening MRI or contrast CT scan)

PATIENT CHARACTERISTICS:

  • ECOG or Zubrod performance status 0-1
  • WBC ≥ 2,500/mm³ (immediately prior to leukapheresis)
  • WBC ≥ 2,000/mm³ (prior to initiation of study therapy)
  • ANC ≥ 1,000/mm³
  • Platelet count ≥ 50,000/mm³
  • Hematocrit ≥ 30% (immediately prior to leukapheresis)
  • Hematocrit ≥ 24% OR hemoglobin ≥ 8 g/dL (prior to initiation of study therapy)
  • Creatinine ≤ 3.0 times upper limit of normal (ULN)
  • AST and ALT ≤ 2.5 times ULN
  • Bilirubin ≤ 3 times ULN
  • Must have adequate venous access
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile female patients must use effective contraception for ≥ 1 month before, during, and for ≥ 8 weeks after the completion of study therapy
  • Fertile male patients must use effective contraception during and for ≥ 3 months after completion of study therapy
  • FEV_1 ≥ 2.0 L or DLCO (corrected for hemoglobin) ≥ 75%
  • No clinically significant pulmonary dysfunction, as determined by medical history and physical exam
  • No active infections or oral temperature > 38.2 C within 72 hours of leukapheresis
  • No significant cardiovascular abnormalities, as defined by any of the following:

    • Congestive heart failure
    • Clinically significant hypotension
    • Symptoms of coronary artery disease
    • Presence of cardiac arrhythmias on EKG requiring drug therapy
    • Ejection fraction < 50% by echocardiogram or MUGA
  • No other malignancy within the past 5 years except adequately treated and cured basal cell or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix
  • No history of inflammatory bowel disease
  • No history of autoimmune disease (e.g., systemic lupus erythematosus, vasculitis, or infiltrating lung disease)
  • No underlying medical condition (e.g., a condition associated with frequent diarrhea) that, in the opinion of the Investigator, would make the administration of study drug hazardous or obscure the interpretation of adverse events
  • No prisoners
  • HIV negative*
  • Hepatitis B and hepatitis C negative* NOTE: *Positive results allowed provided they are not indicative of true active or chronic infection

PRIOR CONCURRENT THERAPY:

  • Recovered from prior therapy
  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas, mitomycin C, or liposomal doxorubicin), radiotherapy, or major surgery
  • At least 4 weeks since prior and no other concurrent immunotherapy (e.g., interleukins, interferons, melanoma vaccines, IV immunoglobulin, expanded polyclonal tumor-infiltrating lymphocytes, or lymphokine-activated killer cell therapy)
  • More than 3 days since prior and no concurrent systemic steroids
  • No concurrent pentoxifylline
  • No other concurrent investigational agents
Last Updated
September 10, 2014
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.