Melanoma Clinical Trial
Official title:
Evaluation of the Safety and Immunogenicity of Intratumoral Injection of Interferon Gamma During Vaccination in Patients With Subcutaneous or Cutaneous Metastases of Melanoma
The goals of this study are to evaluate 1) the safety of administration of intratumoral interferon gamma with a peptide-based vaccine, in patients with melanoma and 2) the biological effects of the vaccine. These include an examination of changes within the tumor following vaccination and the evaluation of T cell responses to the vaccine both in the blood and at the sight of tumor.
Melanoma vaccines have been associated with major regressions in a small percentage of
patients with advanced measurable disease. This provides proof-of-principle of the potential
for clinical benefit with melanoma vaccines however, the current response rate is low. Thus,
there is a critical need for additional new therapies for melanoma, both for adjuvant
therapy of high-risk resected melanoma and for therapy of patients who are not candidates
for, or fail, other therapies in the setting of advanced disease.
It is generally agreed that one mechanism to improve the immunologic outcomes of vaccine
therapy is to optimize T cell trafficking to the tumor site. CXCR3 is the chemokine receptor
on T cells which directs them to sites of inflammation by following the chemokine gradient.
The ligands for CXCR3 (CXCL9 (MIG), CXCL10 (IP-10) and CXCL11 (I-TAC)) are known to be
induced by interferon gamma. This protocol proposes administering a peptide vaccine to
activate tumor antigen-specific CD8+ T cells expressing CXCR3, followed by intratumoral
interferon gamma to increase CXCR3 ligands (CXCL9-11) at the tumor site and recruit the
CXCR3+ T cells.
The primary goals of the proposed work are to assess the safety of the combination of
peptide vaccine and intratumoral interferon gamma and to assess the immunologic outcomes at
the tumor site.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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