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Merkel Cell Carcinoma

Intratumoral Injection of GLA-SE for Merkel Cell Carcinoma (8072)
A Proof-of-concept Clinical Trial of Intratumoral Injection of GLA-SE, a Toll-like Receptor-4 Agonist, in Patients with Merkel Cell Carcinoma
Status Conditions Phase Study ID
Recruiting Merkel Cell Carcinoma Phase I 8072
NCT02035657
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.


Investigator
Shailender Bhatia, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
  • 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
Exclusions (conditions that would prevent participation in this study)
  • 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

Other exclusion criteria may apply.

Last Updated
May 22, 2014
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.