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

Primary Purpose

Melanoma, Squamous Cell Carcinoma of the Head and Neck, Squamous Cell Carcinoma of the Skin

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Poly-ICLC
Sponsored by
Nina Bhardwaj
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma focused on measuring 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

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Icahn School of Medicine at Mount Sinai

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IT and IM injections Poly-ICLC

Arm Description

Enrolled patients will receive two cycles of Poly-ICLC treatment. Each priming (intratumoral injections - IT) and boosting (intramuscular injections - IM) treatment course will constitute one cycle.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
November 5, 2013
Last Updated
December 21, 2017
Sponsor
Nina Bhardwaj
Collaborators
Oncovir, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01984892
Brief Title
Treatment of Solid Tumors With Intratumoral Hiltonol® (Poly-ICLC)
Acronym
Hiltonol
Official Title
Treatment of Solid Tumors With Intratumoral Hiltonol® (Poly-ICLC): A Phase II Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Terminated
Why Stopped
PI discretion, low enrollment
Study Start Date
November 2013 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nina Bhardwaj
Collaborators
Oncovir, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IT and IM injections Poly-ICLC
Arm Type
Experimental
Arm Description
Enrolled patients will receive two cycles of Poly-ICLC treatment. Each priming (intratumoral injections - IT) and boosting (intramuscular injections - IM) treatment course will constitute one cycle.
Intervention Type
Drug
Intervention Name(s)
Poly-ICLC
Other Intervention Name(s)
Hiltonol®
Intervention Description
Cycle 1-Weeks 1 and 2: 1mg Poly-ICLC intratumoral (IT) injections (t=6) into same lesion over 2 weeks. Weeks 3-9: 1mg Poly-ICLC 2x/week intramuscularly (IM) into thighs or upper arms. Week 10: No treatment. CT scan of chest, abdomen, pelvis and extremities or neck; possible MRI brain scan. Cycle 2-Weeks 11 and 12: 1mg Poly-ICLC IT injections (t=6) into same lesion over 2 weeks. Weeks 13-19 - 1mg Poly-ICLC 2x/weekly IM in thighs or upper arms. Weeks 20-26: no treatment. Week 26, evaluate response in absence of inflammation. Maintenance - Weeks 27-36: For patients with stable disease or response; IM poly-ICLC injections; evaluation of clinical and immune response. Week 38 repeat tumor assessment, optional biopsy Follow Up via phone every 3 months for 30months, after completion of treatments.
Primary Outcome Measure Information:
Title
Progression-free Survival
Description
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.
Time Frame
average 52 weeks
Secondary Outcome Measure Information:
Title
Therapeutic Effect in Treated Patients
Description
Induction of innate and/or an adaptive, specific anti-tumor T cell immune response in the injected tumor lesion and also systemically.
Time Frame
24 months
Other Pre-specified Outcome Measures:
Title
Overall Survival in Treated Patients
Description
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
Time Frame
up to 30 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nina Bhardwaj, MD, PhD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States

12. IPD Sharing Statement

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

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