Clinical trial NCT00924001 (phase 1/phase 2, status: terminated)
Conditions: melanoma, malignant melanoma, melanoma, experimental
ICD codes: C43.0, C43.31, D03.9, C43.51, C43.9, D03.0, C43.4, C43.0, C43.31, C43.51, C43.9, C43.4, C43.52, C43.10, C43.0, C43.31, D03.9, C43.51, C43.9, D03.0, C43.4
Drugs: dmf5 melanoma reactive til, cyclophosphamide, fludarabine, aldesleukin
SMILES: ClCCN(CCCl)P1(=O)NCCCO1, ClCCN(CCCl)P1(=O)NCCCO1
Reason stopped: 
    study was stopped due to low accrual
  
Eligibility criteria:

        -INCLUSION CRITERIA:

          1. Measurable metastatic melanoma that is refractory to standard treatment including high
             dose aldesleukin.

          2. Unsuitable autologous cells for Institutional Review Board (IRB) approved Surgery
             Branch adoptive cell therapy studies.

          3. Greater than or equal to 18 years of age.

          4. Life expectancy of greater than three months.

          5. Willing to sign a durable power of attorney.

          6. Able to understand and sign the Informed Consent Document.

          7. Human leukocyte antigen A (HLA-A) 0201 positive.

          8. Willing to practice birth control during treatment and for four months after receiving
             the preparative regimen.

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

         10. Hematology:

               -  Absolute neutrophil count greater than 1000/mm^3 without support of filgrastim.

               -  WBC greater than 3000/mm^3.

               -  Hemoglobin greater than 8.0 g/dl.

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

         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 hepatitis C antibody unless antigen
                  negative.

         12. Chemistry:

               -  Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) less than
                  three times the upper limit of normal.

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

               -  Total bilirubin less than or equal to 2.0 mg/dl, except in patients with
                  Gilbert's Syndrome who must have a total bilirubin less than 3.0 mg/dl.

         13. 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).

         14. Six weeks must have elapsed since prior Ipilimumab (MDX-010) therapy to allow antibody
             levels to decline.

         15. Patients who have previously received MDX-010 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 preparative chemotherapy on the fetus or infant.

          2. 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.

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

          4. Opportunistic infections (The experimental treatment being evaluated in his 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. Symptomatic central nervous system (CNS) lesions (Patients maybe eligible after
             treatment of their symptomatic lesions.)

          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 or ischemic symptoms.

          9. Patients with a prolonged (greater than 20 pk/yrs) history of cigarette smoking or
             symptoms of respiratory dysfunction with pulmonary function tests (PFT's) indicating
             an forced expiratory volume (FEV1) less than 60 percent predicted for age.

         10. Patients with a history of clinically significant atrial and/or ventricular
             arrhythmias including but not limited to: atrial fibrillation, ventricular
             tachycardia, heart block or greater than or equal to age 60 with an left ventricular
             ejection fraction (LVEF) of less than 45 percent on cardiac evaluation
             (echocardiogram, multi-gated acquisition scan (MUGA), etc.) will be excluded.

         11. Positive allo-specific reactivity of the DMF5 cells to the patient's peripheral blood
             mononuclear cells (PBMC).

         12. Documented penicillin allergy.