NCT01984892|TerminatedPhase 2ResultsDMC
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PI discretion, low enrollment
Hiltonol
Sponsor study identifier
Secondary identifiers
OTHER_GRANT · Mount Sinai School of Medicine - Departmental Funds
interventional
8
1 country
1
Study Start
November 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2014
Actual (reported)Study Completion
August 2014
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2014
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2013
Date type not reportedThis date has not been verified as actual or estimated.
November 5, 2013
Actual (reported)November 15, 2013
Actual (reported)August 2014
Actual (reported)August 2014
Actual (reported)January 23, 2018
Actual (reported)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
Therapeutic Effect in Treated Patients
24 months
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.
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
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Nina Bhardwaj, MD, PhD
Icahn School of Medicine at Mount Sinai
8 participants (actual enrollment reported by the registry).
First Submitted
November 5, 2013
First Posted
November 15, 2013
Study Start
November 2013
Date type not reportedThis date has not been verified as actual or estimated.
T Cell Receptor Immunotherapy Targeting NY-ESO-1 for Patients With NY-ESO-1 Expressing Cancer
Overall Survival in Treated Patients
up to 30 months
Contact the study team to confirm eligibility.
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Primary Completion
August 2014
Actual (reported)Study Completion
August 2014
Actual (reported)Last Updated
January 23, 2018
Results First Posted
January 23, 2018
Record last verified: 2017-12
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