Vaccine Therapy in Treating Patients With Advanced Stage III-IV Melanoma

Status Terminated

Clinical Trial Summary

This phase I trial studies the side effects and best dose of vaccine therapy in treating patients with stage III-IV melanoma that has spread to other places in the body and usually cannot be cured or controlled with treatment (advanced). Vaccines made from peptides or antigens may help the body build an effective immune response to kill tumor cells.

Clinical Trial Description

PRIMARY OBJECTIVES: I. To estimate the maximum tolerated dose (MTD) and clinically appropriate dose of human heat shock protein (hsp)110-gp100 chaperone complex melanoma vaccine (recombinant hsp110-gp100 chaperone complex vaccine) to recommend a phase II dose in stage IIIB/C and stage IV metastatic melanoma patients. SECONDARY OBJECTIVES: I. To examine the effect of the recombinant human hsp110-gp100 chaperone complex vaccine on measurable clinical tumor. II. To determine gp100 and hsp110 specific cell mediated and humoral immune responses elicited by the chaperone complex vaccine. III. To determine the effect of dose and serial administration of the chaperone complex vaccine on cell mediated and humoral immune responses. IV. To quantify patient characteristics (human leukocyte antigen [HLA] subtype, immune cell function, etc.) that may correlate with immune response to the chaperone complex vaccine. OUTLINE: This is a dose-escalation study. Patients receive recombinant hsp110-gp100 chaperone complex vaccine intradermally (ID) on days 1, 15, and 43 in the absence of unacceptable toxicity. After completion of study treatment, patients are followed up for 6 months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01744171
Study type	Interventional
Source	Roswell Park Cancer Institute
Contact
Status	Terminated
Phase	Phase 1
Start date	March 26, 2013
Completion date	June 11, 2018

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See also
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