Vaccine Therapy in Treating Patients With Advanced Stage III-IV Melanoma
|Recurrent Melanoma Stage IIIB Skin Melanoma Stage IIIC Skin Melanoma Stage IV Skin Melanoma||Biological: Recombinant Human Hsp110-gp100 Chaperone Complex Vaccine Other: Laboratory Biomarker Analysis||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||A Phase I Trial of a Recombinant Human hsp110-gp100 Chaperone Complex Vaccine for Advanced Stage IIIB/C or IV Melanoma|
- MTD of recombinant human hsp110-gp100 chaperone complex melanoma vaccine based on the probability of dose-limiting toxicity (DLT), graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4 [ Time Frame: Up to 30 days after the last vaccine dose ]DLT is defined as grade 3 or 4 toxicity or grade 3 injection site toxicity, with the exception of grade 3 rigors/chills which will be tolerated for 48-72 hours if attributable to vaccine reaction.
- Objective tumor response according to RECIST version 1.1 [ Time Frame: Up to 6 months ]Recombinant hsp110-gp100 chaperone complex vaccine specific cell mediated and humoral immune responses elicited by the chaperone complex vaccine as well as the effect of dose and serial administration on these responses will be assessed through the correlative science studies.
|Actual Study Start Date:||March 26, 2013|
|Estimated Study Completion Date:||June 13, 2018|
|Estimated Primary Completion Date:||August 13, 2017 (Final data collection date for primary outcome measure)|
Experimental: Treatment (recombinant hsp110-gp100 chaperone complex vaccine)
Patients receive recombinant hsp110-gp100 chaperone complex vaccine ID on days 1, 15, and 43 in the absence of unacceptable toxicity.
Biological: Recombinant Human Hsp110-gp100 Chaperone Complex Vaccine
Given IDOther: Laboratory Biomarker Analysis
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01744171
|United States, New York|
|Roswell Park Cancer Institute||Recruiting|
|Buffalo, New York, United States, 14263|
|Contact: Roswell Park 877-275-7724 ASKRPCI@roswellpark.org|
|Principal Investigator: John M. Kane|
|Principal Investigator:||John Kane||Roswell Park Cancer Institute|