Treatment of Solid Tumors With Intratumoral Hiltonol® (Poly-ICLC)
NCT ID: NCT01984892
Last Updated: 2018-01-23
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
8 participants
INTERVENTIONAL
2013-11-30
2014-08-31
Brief Summary
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Poly-ICLC is a compound that has been used to help the body in its fight against cancer.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Poly-ICLC
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.
Interventions
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Poly-ICLC
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
14 Years
ALL
No
Sponsors
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Oncovir, Inc.
INDUSTRY
Nina Bhardwaj
OTHER
Responsible Party
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Nina Bhardwaj
Director, Immunotherapy Program
Principal Investigators
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Nina Bhardwaj, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Locations
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Icahn School of Medicine at Mount Sinai
New York, New York, United States
Countries
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References
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Other Identifiers
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BB-43984
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
GCO 13-1687
Identifier Type: -
Identifier Source: org_study_id
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