Treatment of Solid Tumors With Intratumoral Hiltonol® (Poly-ICLC)
Condition: Melanoma; Squamous Cell Carcinoma of the Head and Neck; Squamous Cell Carcinoma of the Skin; Sarcoma of the Skin; Basal Cell Cancer of the Skin; Breast Cancer
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Neoplasms, Basal Cell; Carcinoma, Basal Cell; Skin Neoplasms
Intervention: Poly-ICLC
Intervention description: 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.
Intervention MeSH terms: Poly ICLC
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 14 Years
Healthy volunteers: No
Keywords: Autologous Vaccination; Intratumoral Injections; Intramuscular Injections; Advanced Accessible Solid Tumors; Poly-ICLC; Phase II Clinical Trial; Safety; Efficacy; Autovaccination; In Situ; Host Targeted Strategy; Overall Survival; Immunotherapy; Adjuvant

Summary:

      The purpose of this study is to test the safety of a course of injections containing
      Poly-ICLC in patients with advanced solid tumors that can be easily and safely reached with a
      needle.

      Poly-ICLC is a compound that has been used to help the body in its fight against cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed diagnosis of melanoma, squamous head and neck cancer,
             sarcoma, squamous cell carcinoma of the skin, basal cell skin cancer, or breast cancer

          -  Sarcoma Patients must be @ least14 yrs of age; all others 18 yrs of age or older.

          -  Un-resectable disease. Patients with resectable disease may be enrolled after having
             refused surgery and documented consultation with a surgeon.

          -  Disease progressed through @ least 1 systemic therapy or through local irradiation
             within the preceding 6 mos.

          -  Radiologically or visually measurable recurrent or metastatic disease and @ least 10mm
             in longest dimension.

          -  At least 1 accessible primary or metastatic tumor site that can be readily injected IT
             with poly-ICLC with or without ultrasound guidance. Lesion can be superficial
             cutaneous, subcutaneous or within a readily accessible lymph node & must measure @
             least 10mm in longest dimension.

          -  Tumor site injection cannot have been irradiated within 8 wks of C1D1

          -  ECOG performance status ≤ 2.

          -  Normal hematologic, renal & liver function. INR<2 if off of anticoagulation. Patients
             on anticoagulation therapy with an INR>2 may be enrolled at the discretion of the
             investigator.

          -  Patients able to provide informed consent.

          -  Must agree to follow acceptable birth control methods and continue for @ least 2 mos.
             after last poly-ICLC dose. Women of childbearing potential must have a (-) pregnancy
             test.

        Exclusion Criteria:

          -  Serious concurrent infection or medical illness.

          -  Bulky intracranial metastatic disease with shift of midline structures or progressive
             brain metastasis. Administration of immunotherapy or conventional chemotherapy
             treatments for metastatic cancer within 4 wks of C1D1

          -  Radiation treatments within 4 wks of C1D1

          -  AIDS defined as a CD4 count < then 200 in the context of HIV sero-positivity or
             chronically is taking immunosuppressive medication such as steroids or transplant
             related medications.

          -  Life expectancy of < than 6 mos.