Clinical trial NCT02224599 (phase 1/phase 2, status: terminated)
Conditions: progressive solid malignancies, refractory solid malignancies, cancer
ICD codes: A81.2, G12.22, G60.3, I67.3, M34.0, Q78.3, G12.25, D46.4, D46.1, D46.A, D46.0, D46.20, D46.21, D46.22, C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: cyclophosphamide pill, imiquimod topical cream
SMILES: ClCCN(CCCl)P1(=O)NCCCO1, CC(C)CN1C=NC2=C1C1=CC=CC=C1N=C2N
Reason stopped: 
    sponsor decision to terminate study due to poor accrual
  
Eligibility criteria:

        Inclusion Criteria:

          1. Ability to provide informed consent.

          2. Patients with histologically proven progressive and/or refractory SM, s/p conventional
             salvage therapy, completed at least 3 weeks prior to study vaccination, will be
             eligible for enrollment.

          3. Expression of one (1) or more of the following TAPAs: Sp17, AKAP-4, Ropporin, PTTG-1,
             Span-xb, Her-2/neu, HM1.24, NY-ESO-1 and MAGE-1, by either RT-PCR and/or
             immunocytochemistry, Western blotting or ELISA, in neoplastic cells and/or blood. For
             HER-2/neu expression, positive FISH results are acceptable.

          4. Presence of measurable or evaluable disease.

          5. Patients must not have any active infectious process.

          6. Patients must not have a history of HIV, or active Hepatitis A, B, and C.

          7. Patients must not be receiving active immunosuppressive therapy.

          8. Patients must have discontinued systemic cytotoxic or radiation therapy at least three
             (3) weeks prior to vaccination and toxicities from previous therapies must be grade 1
             or less. all other FDA approved forms of antineoplastic therapy are allowed such as
             immunotherapy, targeted therapies, or hormonal therapies (67, 68)

          9. Patients may not have any known allergy to CYP and/or Imiquimod.

         10. Patients must be willing to provide at least 250 mL, and up to 500 mL, of whole blood
             obtained by phlebotomy and/or consent to leukapheresis for DC generation.

         11. Adequate renal and hepatic function (creatinine ≤ 2.0 mg/dl, bilirubin ≤ 2.0 mg/dl,
             AST and ALT ≤ 4X upper limit of normal range).

         12. Adequate hematologic function (Platelets ≥ 60,000/mm3, lymphocytes ≥ 1,000 mm3,
             neutrophils ≥ 750/mm3, hemoglobin ≥ 9.0 g/dl).

         13. Karnofsky performance status ≥ 70%.

         14. Expected survival ≥ 6 months.

         15. Either a female or male of reproductive capacity wishing to participate in this study
             must be using, or agree to use, one or more types of birth control during the entire
             study and for 3 months after completing the study. Birth control methods may include
             condoms, diaphragms, birth control pills, spermicidal gels or foams, anti-gonadotropin
             injections, intrauterine devices (IUD), surgical sterilization, or subcutaneous
             implants. Another choice is for a subject's sexual partner to use one of these birth
             control methods. Women of reproductive capacity will be required to undergo a urine
             pregnancy test before completion of the post-screening informed consent process.

        Exclusion Criteria:

          1. Patients without confirmed progressive and/or refractory SM using standard RECIST
             criteria.

          2. Patients without measurable or evaluable disease.

          3. Patients receiving cytotoxic therapy or radiation therapy, within three (3) weeks of
             vaccination.

          4. Active immunosuppressive therapy, including non-physiologic systemic steroids
             (excluding topical, intraocular, inhaled, and intranasal steroids) for any other
             condition.

          5. Persistent fever (>24 hours) documented by repeated measurement or active,
             uncontrolled infection within 4 weeks of enrollment.

          6. Active ischemic heart disease or history of myocardial infarction within six months.

          7. Active autoimmune disease, including, but not limited to, Systemic Lupus Erythematosus
             (SLE), Multiple Sclerosis (MS), Ankylosing Spondylitis (AS), Inflammatory Bowel
             Disease (IBD) and Rheumatoid Arthritis (RA).

          8. Pregnancy or breast feeding.

          9. Active second invasive malignancy, other than basal cell carcinoma of the skin.

         10. Life expectancy of less than 6 months.

         11. Patients with contraindications to CYP and/or Imiquimod.

         12. Patients who have received organ transplants.

         13. Patients with psychological or geographic conditions that prevent adequate follow- up
             or compliance with the study protocol.