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Clinical Cancer Research Vol. 7, 3012-3024, October 2001
© 2001 American Association for Cancer Research

Regular Articles

Phase I Trial of a Melanoma Vaccine with gp100280–288 Peptide and Tetanus Helper Peptide in Adjuvant

Immunologic and Clinical Outcomes1

Craig L. Slingluff, Jr.2, Galina Yamshchikov, Patrice Neese, Holly Galavotti, Shannon Eastham, Victor H. Engelhard, Dave Kittlesen3, Donna Deacon, Sarah Hibbitts, William W. Grosh, Gina Petroni, Roger Cohen, Catie Wiernasz, James W. Patterson, Brian P. Conway and William G. Ross

Departments of Surgery [C. L. S., G. Y., P. N., H. G., S. E., D. K., D. D., S. H.], Medicine [W. W. G., R. C.], Health Evaluation Sciences [G. P.], Microbiology and Beirne Carter Center for Immunology Research [V. H. E.], Cancer Center Clinical Trials Office [C. W.], Pathology [J. W. P.], Ophthalmology [B. P. C.], and Cancer Center FACS Core Facility [W. G. R.], University of Virginia, Charlottesville, Virginia 22906

A melanoma vaccine composed of HLA-A2-restricted peptide YLEPGPVTA (gp100280), with or without a modified T-helper epitope from tetanus toxoid AQYIKANSKFIGITEL, has been evaluated in a Phase I trial to assess safety and immunological response. The vaccines were administered s.c. in either of two adjuvants, Montanide ISA-51 or QS-21, to 22 patients with high-risk resected melanoma (stage IIB–IV). Local and systemic toxicities were mild and transient. We detected CTL responses to the gp100280 peptide in peripheral blood in 14% of patients. Helper T-cell responses to the tetanus helper peptide were detected in 79% of patients and had a Th1 cytokine profile. One patient with a CTL response to gp100 had a recurrence in a lymph node 2 years later; her nodes contained CD8+ cells reactive to gp100280 (0.24%), which proliferated in response to peptide. The overall survival of patients is 75% (95% confidence interval, 57–94%) at 4.7 years follow-up, which compares favorably with expected survival. Four of 14 patients who completed at least six vaccines subsequently developed metastases, all of which were solitary and surgically resectable. They remain alive and clinically free of disease at last follow-up. Data from this trial demonstrate immunogenicity of the gp100280 peptide and suggest that immune responses may persist long-term in some patients. The frequency and magnitude of the CTL response may be improved with more aggressive vaccination regimens. Although this Phase I study was not intended to evaluate clinical benefit, the excellent survival of patients on this protocol suggests the possibility of a benefit that should be assessed in future studies.




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Copyright © 2001 by the American Association for Cancer Research.