8
Participants
Start Date
November 30, 2013
Primary Completion Date
August 31, 2014
Study Completion Date
August 31, 2014
Poly-ICLC
"Cycle 1-Weeks 1 and 2: 1mg Poly-ICLC intratumoral (IT) injections (t=6) into same lesion over 2 weeks.~Weeks 3-9: 1mg Poly-ICLC 2x/week intramuscularly (IM) into thighs or upper arms.~Week 10: No treatment. CT scan of chest, abdomen, pelvis and extremities or neck; possible MRI brain scan.~Cycle 2-Weeks 11 and 12: 1mg Poly-ICLC IT injections (t=6) into same lesion over 2 weeks.~Weeks 13-19 - 1mg Poly-ICLC 2x/weekly IM in thighs or upper arms.~Weeks 20-26: no treatment. Week 26, evaluate response in absence of inflammation.~Maintenance - Weeks 27-36: For patients with stable disease or response; IM poly-ICLC injections; evaluation of clinical and immune response. Week 38 repeat tumor assessment, optional biopsy~Follow Up via phone every 3 months for 30months, after completion of treatments."
Icahn School of Medicine at Mount Sinai, New York
Collaborators (1)
Oncovir, Inc.
INDUSTRY
Nina Bhardwaj
OTHER