Clinical Trial Details
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NCT01984892 : Treatment of Solid Tumors With Intratumoral Hiltonol® (Poly-ICLC)
PhasePhase 2
AgesMin: 14 Years Max: N/A
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

- 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

- 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

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.
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