Breast Cancer Clinical Trial
— HiltonolOfficial title:
Treatment of Solid Tumors With Intratumoral Hiltonol® (Poly-ICLC): A Phase II Clinical Study
Verified date | December 2017 |
Source | Icahn School of Medicine at Mount Sinai |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 8 |
Est. completion date | August 2014 |
Est. primary completion date | August 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 14 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Icahn School of Medicine at Mount Sinai | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Nina Bhardwaj | Oncovir, Inc. |
United States,
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* Note: There are 33 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Overall Survival in Treated Patients | Patients who are alive on the date of closing follow-up, or 30 months after completing all study treatments, will be censored on that date | up to 30 months | |
Primary | Progression-free Survival | Progression-free survival defined as the time in weeks from study entry until tumor progression defined using the Wolchok criteria or death. Patients who are alive and free from progression on the date of closing follow-up will be censored on that date. In order to minimize the potential for misdiagnosis of pseudoprogression, related to early inflammation, tumor measurement for determination of progression will be made at the earliest at 26 weeks. |
average 52 weeks | |
Secondary | Therapeutic Effect in Treated Patients | Induction of innate and/or an adaptive, specific anti-tumor T cell immune response in the injected tumor lesion and also systemically. | 24 months |
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