Clinical trial NCT02062359 (phase 2, status: terminated)
Conditions: metastatic cancer, metastatic melanoma
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2, C43.0, C43.31, D03.9, C43.51, C43.9, D03.0, C43.4
Drugs: aldesleukin, cyclophosphamide, fludarabine
SMILES: ClCCN(CCCl)P1(=O)NCCCO1, ClCCN(CCCl)P1(=O)NCCCO1
Reason stopped: 
    study was closed due to poor accrual.
  
Eligibility criteria:

        -INCLUSION CRITERIA:

          1. Measurable metastatic melanoma that expresses ESO as assessed by one of the following
             methods: reverse transcription-polymerase chain reaction (RT-PCR) on tumor tissue, or
             by immunohistochemistry of resected tissue, or serum antibody reactive with ESO.

          2. Confirmation of diagnosis of metastatic melanoma by the Laboratory of Pathology of the
             National Cancer Institute (NCI).

          3. Patients with 3 or fewer brain metastases that are less than 1 cm in diameter and
             asymptomatic are eligible. Lesions that have been treated with stereotactic
             radiosurgery must be clinically stable for 1 month after treatment for the patient to
             be eligible. Patients with surgically resected brain metastases are eligible.

          4. Greater than or equal to 18 years of age and less than or equal to 70 years of age.

          5. Willing to sign a durable power of attorney

          6. Able to understand and sign the Informed Consent Document

          7. Clinical performance status of Eastern Cooperative Oncology Group (ECOG) 0 or 1

          8. Life expectancy of greater than three months

          9. Patients must be human leukocyte antigen (HLA)-A*0201 positive

         10. Patients of both genders must be willing to practice birth control from the time of
             enrollment on this study and for up to four months after treatment

         11. Serology:

               -  Seronegative for human immunodeficiency virus (HIV) antibody. (The experimental
                  treatment being evaluated in this protocol depends on an intact immune system.
                  Patients who are HIV seropositive can have decreased immune-competence and thus
                  be less responsive to the experimental treatment and more susceptible to its
                  toxicities.)

               -  Seronegative for hepatitis B antigen, and seronegative for hepatitis C antibody.
                  If hepatitis C antibody test is positive, then patient must be tested for the
                  presence of antigen by RT-PCR and be hepatitis C virus (HCV) ribonucleic acid
                  (RNA) negative.

         12. Women of child-bearing potential must have a negative pregnancy test because of the
             potentially dangerous effects of the treatment on the fetus.

         13. Hematology

               -  Absolute neutrophil count greater than 1000/mm(3) without the support of
                  filgrastim

               -  White blood cell (WBC) greater than or equal to 3000/mm(3)

               -  Platelet count greater than or equal 100,000/mm(3)

               -  Hemoglobin > 8.0 g/dl

         14. Chemistry:

               -  Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) less than
                  or equal to 2.5 times the upper limit of normal

               -  Serum creatinine less than or equal to 1.6 mg/dl

               -  Total bilirubin less than or equal to 1.5 mg/dl, except in patients with Gilberts
                  Syndrome who must have a total bilirubin less than 3.0 mg/dl.

         15. More than four weeks must have elapsed since any prior systemic therapy at the time
             the patient receives the preparative regimen, and patients toxicities must have
             recovered to a grade 1 or less (except for toxicities such as alopecia or vitiligo).

             Note: Patients may have undergone minor surgical procedures within the past 3 weeks,
             as long as all toxicities have recovered to grade 1 or less or as specified in the
             eligibility criteria in Section 2.1.

         16. Six weeks must have elapsed from the time of any antibody therapy that could affect an
             anti cancer immune response, including anti-cytotoxic T-lymphocyte antigen 4 (CTLA4)
             antibody therapy, toat the time the patient receives the preparative regimen to allow
             antibody levels to decline.

        Note: Patients who have previously received ipilimumab and have documented gastrointestinal
        (GI) toxicity must have a normal colonoscopy with normal colonic biopsies.

        EXCLUSION CRITERIA:

          1. Women of child-bearing potential who are pregnant or breastfeeding because of the
             potentially dangerous effects of the treatment on the fetus or infant.

          2. Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency
             Disease).

          3. Active systemic infections, coagulation disorders or other major medical illnesses of
             the cardiovascular, respiratory or immune system, myocardial infarction, cardiac
             arrhythmias, obstructive or restrictive pulmonary disease.

          4. Concurrent opportunistic infections (The experimental treatment being evaluated in
             this protocol depends on an intact immune system. Patients who have decreased immune
             competence may be less responsive to the experimental treatment and more susceptible
             to its toxicities).

          5. Concurrent systemic steroid therapy.

          6. History of severe immediate hypersensitivity reaction to any of the agents used in
             this study.

          7. History of coronary revascularization or ischemic symptoms

          8. Documented left ventricular ejection fraction (LVEF) of less than or equal to 45%.
             Testing is required in patients with:

               -  Clinically significant atrial and/or ventricular arrhythmias including but not
                  limited to: atrial fibrillation, ventricular tachycardia, second or third degree
                  heart block

               -  Age greater than or equal to 60 years old