Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:34 PM
Ignite Modification Date:
2025-12-24 @ 3:34 PM
NCT ID:
NCT01984892
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
14 Years
Study:
NCT01984892
Study Brief:
Protocol Section:
NCT01984892