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A Proof-of-Concept Trial of GLA-SE in Patients With Merkel Cell Carcinoma

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ClinicalTrials.gov Identifier: NCT02035657
Recruitment Status : Completed
First Posted : January 14, 2014
Last Update Posted : June 13, 2018
Sponsor:
Information provided by (Responsible Party):
Immune Design

Brief Summary:
This is a single arm, open-label, single center study evaluating the safety, feasibility, clinical efficacy and immunogenicity of GLA-SE administration to patients with Merkel cell carcinoma. Ten patients will be treated. The goal is for GLA-SE to assist the patient's own immune system in attacking the cancer cells.

Condition or disease Intervention/treatment Phase
Merkel Cell Carcinoma Biological: GLA-SE Phase 1

Detailed Description:
This is a single arm, open-label, single center study evaluating the safety, feasibility, clinical efficacy and immunogenicity of GLA-SE administration to patients with Merkel cell carcinoma. Ten patients with metastatic or locoregional disease will be treated. The goal is for GLA-SE to assist the patient's own immune system in attacking the cancer cells.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Proof-of-Concept Clinical Trial of Intratumoral Injection of GLA-SE, a Toll-like Receptor-4 Agonist, in Patients With Merkel Cell Carcinoma
Actual Study Start Date : January 2014
Actual Primary Completion Date : March 2018
Actual Study Completion Date : March 2018


Arm Intervention/treatment
Experimental: GLA-SE
Glucopyranosyl Lipid A in Stable Emulsion
Biological: GLA-SE
Glucopyranosyl Lipid A in Stable Emulsion
Other Name: Glucopyranosyl Lipid A in Stable Emulsion




Primary Outcome Measures :
  1. Safety and feasibility [ Time Frame: 1 year ]
    The number of treatment-related adverse events


Secondary Outcome Measures :
  1. Clinical efficacy and Immunogenicity [ Time Frame: 1 Year ]
    The secondary objectives are to assess the clinical efficacy of as well as the immunological effects of GLA-SE in patients with MCC

  2. Clinical efficacy and Immunogenicity [ Time Frame: 1 Year ]
    Objective tumor response rate, time to progression or relapse, survival, and cellular immune activation



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Biopsy-confirmed Merkel cell carcinoma with metastatic or loco-regional disease.
  • Patients must have at least one injectable lesion, defined as an easily palpable superficial lesion (cutaneous, subcutaneous or lymph nodal metastasis) that can be accurately localized, stabilized by palpation, and is superficial enough to enable IT injection.
  • ECOG performance status score 0, 1 or 2
  • ≥ 18 years of age
  • Life expectancy of ≥ three months.
  • Adequate neutrophil and platelet counts
  • Adequate renal and hepatic function
  • Willing to undergo pre-treatment lesion biopsy and post-treatment lesion biopsy
  • Use of effective contraception
  • Signed informed consent document
  • Members of all genders, races and ethnic groups are eligible for this trial

Exclusion Criteria:

  • Prior chemotherapy or a major surgical procedure within 3 weeks, or radiotherapy within 2 weeks prior to first study treatment
  • No concurrent anti-cancer treatment (including topical agents such as imiquimod) or investigational agents
  • Active, untreated brain metastases
  • Pregnant or nursing
  • Use of any systemic immunosuppressive agents
  • Immunosuppressed patients
  • Uncontrolled depression or other major psychiatric disorder

Information from the National Library of Medicine

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): NCT02035657


Locations
United States, Washington
University of Washington Medical Center, Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Immune Design
Investigators
Study Director: Frank Hsu, MD Immune Design

Responsible Party: Immune Design
ClinicalTrials.gov Identifier: NCT02035657     History of Changes
Other Study ID Numbers: IDC-G100-2013-001
First Posted: January 14, 2014    Key Record Dates
Last Update Posted: June 13, 2018
Last Verified: June 2018

Keywords provided by Immune Design:
Merkel cell carcinoma
MCC

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Merkel Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Polyomavirus Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Carcinoma, Neuroendocrine
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Adenocarcinoma
Neoplasms, Nerve Tissue