Treatment of Solid Tumors With Intratumoral Hiltonol® (Poly-ICLC)

PHASE2TerminatedINTERVENTIONAL
Enrollment

8

Participants

Timeline

Start Date

November 30, 2013

Primary Completion Date

August 31, 2014

Study Completion Date

August 31, 2014

Conditions
MelanomaSquamous Cell Carcinoma of the Head and NeckSquamous Cell Carcinoma of the SkinSarcoma of the SkinBasal Cell Cancer of the SkinBreast Cancer
Interventions
DRUG

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."

Trial Locations (1)

10029

Icahn School of Medicine at Mount Sinai, New York

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Oncovir, Inc.

INDUSTRY

lead

Nina Bhardwaj

OTHER

NCT01984892 - Treatment of Solid Tumors With Intratumoral Hiltonol® (Poly-ICLC) | Biotech Hunter | Biotech Hunter