Clinical trial NCT01984892: Treatment of Solid Tumors With Intratumoral Hiltonol® (Poly-ICLC)
Official title: Treatment of Solid Tumors With Intratumoral Hiltonol® (Poly-ICLC): A Phase II Clinical Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: 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
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
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Oncovir, Inc.
First posted: 2013-11-15
Enrollment: 8
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: We hypothesize that this therapeutic in-situ autovaccination strategy is comprised of three immunomodulatory steps. The first is the innate immune local tumor killing induced by intratumoral Hiltonol (via NK, TNF, etc). A very close second step is optimal Th1-weighted priming through the in-situ combination of the poly-ICLC danger signal with the tumor antigens released in step 1 and further processed and cross-presented by poly-ICLC activated mDC, etc. The repeated administration of the Hiltonol danger signal IT in the context of the patient's own tumor antigens and in a way that mimics a natural viral infection may be critical to this step. Once the system is optimally primed, the third step is targeting and maintenance of the immune response and its facilitation at remote tumor sites with IM poly-ICLC through chemokine release, inflammasome activation and other costimulatory factors.

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.

Primary outcomes:
measure: Progression-free Survival
timeFrame: average 52 weeks
Secondary outcomes:
measure: Therapeutic Effect in Treated Patients
timeFrame: 24 months
Other outcomes:
measure: Overall Survival in Treated Patients
timeFrame: up to 30 months
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Nina Bhardwaj, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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