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

• Status: Terminated
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nina Bhardwaj
• Collaborator: Oncovir, Inc.
• Treatments: Carboxymethylcellulose Sodium; Poly I-C; Poly ICLC

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.