NCT00977145

Evaluating the Safety and the Biological Effects of Intratumoral Interferon Gamma and a Peptide-Based Vaccine in Patients With Melanoma

Evaluation of the Safety and Immunogenicity of Intratumoral Injection of Interferon Gamma During Vaccination in Patients With Subcutaneous or Cutaneous Metastases of Melanoma

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Craig L Slingluff, Jr · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	A combination of intratumoral IFN-gamma plus systemic vaccination with MELITAC 12.1	Vaccine regimen: The vaccines will be administered in two treatment cycles. During cycle one, three vaccines will be administered over a 3-week period on days 1, 8, 15. During cycle two, three vaccines will be administered over a 9-week period on days 24, 43, 64. All participants will receive 12-MP (100 mcg each peptide) plus Peptide-tet (Peptide-tet; 200 mcg) administered in Montanide ISA-51 VG adjuvant. The vaccine will be administered subcutaneously (1 ml) and intradermally (1ml) at a single vaccination site. Intratumoral Interferon regimen: On day 22, patients will have one or more tumor sites injected with 0.5-2 million IU of IFN-gamma each, with a maximum dose of 2 million IU of IFN-gamma administered per patient. The number of lesions that are injected will be dependent on the availability and size of the lesions.

Timeline

• Start date: 2009-11-01
• Primary completion: 2012-10-01
• First posted: 2009-09-15
• Last updated: 2016-12-16

Locations

1 site across 1 country: United States