Statement: the primary trial studies the effects of CTX/IMQ/RT and Epothilone on Central Nervous System (CNS) Progression-free Survival(PFS), 9 weeks after the start of treatment.
Primary_evidence: Outcome Measurement:    Systemic Tumor Response Rates (Complete Response+Partial Response)   The systemic tumor response refers to the response at the time of best overall response. The response criteria are specially adapted from Response Evaluation Criteria in Solid Tumor for Immunotherapies (Wolchok, et al., 2009).   Time frame: 9 weeks from the start of the treatment of RT Results 1:    Arm/Group Title: IMQ+RT   Arm/Group Description: This arm has been closed as of 6/4/2014.   Weeks 1-2: RT given to one metastatic skin site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W)   Weeks 1-8: day 1-5 of each week: imiquimod 5% cream applied to all skin sites overnight, starting on day 1 after RT, day 6-7 of each week: rest period.   Week 9: response assessment   Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator.   Radiation   Imiquimod   Overall Number of Participants Analyzed: 12   Measure Type: Number   Unit of Measure: proportion of tumors  .25        (.06 to .57) Results 2:    Arm/Group Title: CTX/IMQ/RT   Arm/Group Description: Week -1 (day-7): cyclophosphamide 200mg/m2 IV as single infusion   Weeks 1-2: RT given to one metastatic skin site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W)   Weeks 1-8: day 1-5 of each week: imiquimod 5% cream applied all sites overnight, starting on day 1 after RT, day 6-7 of each week: rest period.   Week 9: response assessment   Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator.   Radiation   Imiquimod   Cyclophosphamide   Overall Number of Participants Analyzed: 12   Measure Type: Number   Unit of Measure: proportion of tumors  .083        (.002 to .38)