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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Immune Design
Sponsor:
Information provided by (Responsible Party):
Immune Design
ClinicalTrials.gov Identifier:
NCT02035657
First received: January 10, 2014
Last updated: April 22, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Merkel Cell Carcinoma
Biological: GLA-SE
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Immune Design:

Primary Outcome Measures:
  • Safety and feasibility [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    The number of treatment-related adverse events


Secondary Outcome Measures:
  • Clinical efficacy and Immunogenicity [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    The secondary objectives are to assess the clinical efficacy of as well as the immunological effects of GLA-SE in patients with MCC

  • Clinical efficacy and Immunogenicity [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    Objective tumor response rate, time to progression or relapse, survival, and cellular immune activation


Estimated Enrollment: 10
Study Start Date: January 2014
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02035657

Contacts
Contact: Frank Hsu, MD 650-887-6703 frank.hsu@immunedesign.com
Contact: Scott Houston 650-887-6703 scott.houston@immunedesign.com

Locations
United States, Washington
University of Washington Medical Center, Seattle Cancer Care Alliance Recruiting
Seattle, Washington, United States, 98109
Contact: Mike Donahue, BS    206-288-7058    mgd@uw.edu   
Principal Investigator: Shailender Bhatia, MD         
Sponsors and Collaborators
Immune Design
  More Information

No publications provided

Responsible Party: Immune Design
ClinicalTrials.gov Identifier: NCT02035657     History of Changes
Other Study ID Numbers: IDC-G100-2013-001
Study First Received: January 10, 2014
Last Updated: April 22, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 16, 2014