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

NCT01984892 | Terminated Phase 2 Results DMC

• 2 other identifiers: GCO 13-1687BB-43984
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Therapeutic Effect in Treated Patients

  24 months

Other Outcomes (1)

• Overall Survival in Treated Patients

  up to 30 months

Study Arms (1)

IT and IM injections Poly-ICLC

EXPERIMENTAL

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.

Drug: Poly-ICLC

Interventions

Poly-ICLC DRUG

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.

Also known as: Hiltonol®

IT and IM injections Poly-ICLC

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nina Bhardwaj: lead
• Oncovir, Inc.: collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

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MeSH Terms

Conditions

Melanoma; Squamous Cell Carcinoma of Head and Neck; Breast Neoplasms

Interventions

poly ICLC

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Head and Neck Neoplasms; Breast Diseases

Results Point of Contact

• Title: Dr. Nina Bhardwaj
• Organization: Icahn School of Medicine at Mount Sinai

nina.bhardwaj@mssm.edu

212-824-8427

Study Officials

• Nina Bhardwaj, MD, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Immunotherapy Program

Study Record Dates

• First Submitted: November 5, 2013
• First Posted: November 15, 2013
• Study Start: November 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: January 23, 2018
• Results First Posted: January 23, 2018

Record last verified: 2017-12

Locations

US (1)