A Proof-of-Concept Trial of GLA-SE in Patients With Merkel Cell Carcinoma
Primary Purpose
Merkel Cell Carcinoma
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
GLA-SE
Sponsored by
About this trial
This is an interventional treatment trial for Merkel Cell Carcinoma focused on measuring Merkel cell carcinoma, MCC
Eligibility 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
Sites / Locations
- University of Washington Medical Center, Seattle Cancer Care Alliance
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
GLA-SE
Arm Description
Glucopyranosyl Lipid A in Stable Emulsion
Outcomes
Primary Outcome Measures
Safety and feasibility
The number of treatment-related adverse events
Secondary Outcome Measures
Clinical efficacy and Immunogenicity
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
Objective tumor response rate, time to progression or relapse, survival, and cellular immune activation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02035657
Brief Title
A Proof-of-Concept Trial of GLA-SE in Patients With Merkel Cell Carcinoma
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
January 2014 (Actual)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
March 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Immune Design
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Merkel Cell Carcinoma
Keywords
Merkel cell carcinoma, MCC
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GLA-SE
Arm Type
Experimental
Arm Description
Glucopyranosyl Lipid A in Stable Emulsion
Intervention Type
Biological
Intervention Name(s)
GLA-SE
Other Intervention Name(s)
Glucopyranosyl Lipid A in Stable Emulsion
Intervention Description
Glucopyranosyl Lipid A in Stable Emulsion
Primary Outcome Measure Information:
Title
Safety and feasibility
Description
The number of treatment-related adverse events
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Clinical efficacy and Immunogenicity
Description
The secondary objectives are to assess the clinical efficacy of as well as the immunological effects of GLA-SE in patients with MCC
Time Frame
1 Year
Title
Clinical efficacy and Immunogenicity
Description
Objective tumor response rate, time to progression or relapse, survival, and cellular immune activation
Time Frame
1 Year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank Hsu, MD
Organizational Affiliation
Immune Design
Official's Role
Study Director
Facility Information:
Facility Name
University of Washington Medical Center, Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Proof-of-Concept Trial of GLA-SE in Patients With Merkel Cell Carcinoma
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