Clinical trial NCT00509496 (phase 2, status: terminated)
Conditions: skin cancer, melanoma
ICD codes: C79.2, C44.500, C44.90, D23.9, D48.5, C44.00, C44.301, C43.0, C43.31, D03.9, C43.51, C43.9, D03.0, C43.4
Drugs: fludarabine phosphate, cyclophosphamide
SMILES: NC1=NC(F)=NC2=C1N=CN2[C@@H]1O[C@H](CO)[C@@H](O)[C@@H]1O, ClCCN(CCCl)P1(=O)NCCCO1
Reason stopped: 
    low accrual
  
Eligibility criteria:

        -  INCLUSION CRITERIA:

               1. Metastatic melanoma with measurable disease.

               2. Previously received high dose aldesleukin (IL-2) and have been either
                  non-responders (progressive disease) or have recurred.

               3. Positive for gp100 by immunohistochemistry (IHC).

               4. Greater than or equal to 18 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.

                  h Life expectancy of greater than three months.

             i. Patients of both genders must be willing to practice birth control for four months
             after receiving the preparative regimen.

             j. Must be human leukocyte antigen (HLA-A 0201) positive

             k. Serology:

               1. 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.)

               2. Seronegative for hepatitis B antigen and hepatitis C antibody unless antigen
                  negative.

             l. Hematology:

               1. Absolute neutrophil count greater than 1000/mm^3.

               2. White blood cell (WBC) (greater than 3000/ mm^3).

               3. Platelet count greater than 100,000/ mm^3.

               4. Hemoglobin greater than 8.0 g/dl.

             m. Chemistry:

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

               2. Serum creatinine less than or equal to 1.6 mg/dl.

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

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

             o. 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).

             p. Six weeks must have elapsed since prior cytotoxic T-lymphocyte antigen 4
             (anti-CTLA4) antibody therapy to allow antibody levels to decline, and patients who
             have previously received must have a normal colonoscopy with normal colonic biopsies.

        EXCLUSION CRITERIA:

          1. Patients with reactive TIL (interferon (IFN)- gamma release greater than 200 pg/mL)
             available based on overnight co-culture assay with autologous tumor or MHC-matched
             tumor cells.

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

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

          5. 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.)

          6. Systemic steroid therapy.

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

          8. History of coronary revascularization.

          9. Documented left ventricular ejection faction (LVEF) of less than 45 percent in
             patients with:

        a. Clinically significant atrial and/or ventricular arrhythmias including but not limited
        to: atrial fibrillation, ventricular tachycardia, 2 degree or 3 degree heart block.

        b. Age greater than or equal to 60 years old.

        j. Documented forced expiratory volume 1 (FEV1) greater than or equal to 60 percent
        predicted for patients with:

          1. A prolonged history of cigarette smoking (greater than 20 pack/year within the past 2
             years).

          2. Symptoms of respiratory distress.