Treatment of Solid Tumors With Intratumoral Hiltonol® (Poly-ICLC) (Hiltonol)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01984892|
Recruitment Status : Terminated (PI discretion, low enrollment)
First Posted : November 15, 2013
Results First Posted : January 23, 2018
Last Update Posted : January 23, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|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||Drug: Poly-ICLC||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treatment of Solid Tumors With Intratumoral Hiltonol® (Poly-ICLC): A Phase II Clinical Study|
|Study Start Date :||November 2013|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||August 2014|
Experimental: IT and IM injections Poly-ICLC
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.
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.
Other Name: Hiltonol®
- Progression-free Survival [ Time Frame: average 52 weeks ]
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.
- Therapeutic Effect in Treated Patients [ Time Frame: 24 months ]Induction of innate and/or an adaptive, specific anti-tumor T cell immune response in the injected tumor lesion and also systemically.
- Overall Survival in Treated Patients [ Time Frame: up to 30 months ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01984892
|United States, New York|
|Icahn School of Medicine at Mount Sinai|
|New York, New York, United States, 10029|
|Principal Investigator:||Nina Bhardwaj, MD, PhD||Icahn School of Medicine at Mount Sinai|