Melanoma (Skin) Clinical Trial
Official title:
Safety and Immunogenicity of Vaccination With Multi-Epitope Peptide Vaccine Containing MART-1, gp100, and Tyrosinase Peptides Given With the Combination of GMCSF and CpG Oligonucleotide (CpG 7909) in ISA-Oil Adjuvant for Patients With Recurrent Inoperable Stage III or Stage IV Melanoma
Verified date | June 2017 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
RATIONALE: Vaccines made from peptides may help the body build an effective immune response
to kill tumor cells. Giving vaccine therapy together with GM-CSF, CpG 7909, and incomplete
Freund's adjuvant may make a stronger immune response and kill more tumor cells.
PURPOSE: This clinical trial is studying the side effects and how well vaccine therapy works
in treating patients with recurrent stage III or stage IV melanoma that cannot be removed by
surgery.
Status | Completed |
Enrollment | 22 |
Est. completion date | December 2011 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
DISEASE CHARACTERISTICS: - Histologically confirmed melanoma meeting the following criteria: - Unresectable recurrent disease - Stage III or IV disease - Cutaneous, ocular, or mucosal melanoma - Measurable disease as defined by the RECIST criteria - HLA-A2 positive - Prior brain metastases allowed provided adequate surgical or radiologic treatment for brain disease PATIENT CHARACTERISTICS: - ECOG performance status 0 or 1 - WBC = 3,000/mm³ - Lymphocytes = 1,000/mm³ - Platelet count = 100,000/mm³ - Creatinine = 1.5 times upper limit of normal (ULN) - Bilirubin = 1.5 times ULN - AST and ALT = 2.5 times ULN - Lactic dehydrogenase = 2.0 times ULN - aPTT < 40 seconds - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception for = 1 week before, during, and for = 2 weeks after completion of study therapy - No conditions of immunosuppression - Negative titers for antinuclear antibody (= 1/80) and antidouble stranded DNA (= 1/10) - No serious illnesses including, but not limited to, any of the following: - Bleeding disorders - Autoimmune diseases - Severe obstructive or restrictive pulmonary diseases - Active systemic infections - Inflammatory bowel disorders - No serious cardiovascular disease including, but not limited to, any of the following: - Uncontrolled congestive heart failure - Hypertension - Cardiac ischemia - Myocardial infarction, - Severe cardiac arrhythmia - HIV1 and 2 negative - HTLV-1 negative - Hepatitis B and C negative - No significant psychiatric disease, medical intervention, or other condition that, in the opinion of the principal investigator, would limit study compliance - No active infection within the past week, including unexplained fever (temperature > 38.1°C) PRIOR CONCURRENT THERAPY: - Fully recovered from prior major surgery - More than 4 weeks since prior chemotherapy (6 weeks for mitomycin C or nitrosoureas), hormonal therapy, radiotherapy, or biological therapy - More than 1 week since prior antibiotics - More than 28 days since prior investigational agent - No prior vaccination with MART-1 (26-35, 27L), gp100 (209-217, 210M), and tyrosinase (368-376, 370D) peptides alone or in combination - Patients with history of vaccination with peptides other than MART-1 (26-35, 27L), gp100 (209-217, 210M), and tyrosinase (368-376, 370D) peptides allowed - More than 4 weeks since prior and no concurrent systemic immunosuppressive therapy, including steroids - Patients on maintenance steroids given at physiologic doses because of adrenal insufficiency are eligible - More than 2 weeks since prior and no concurrent treatment with systemic steroids, including oral steroids, continuous use of topical steroid creams or ointments, or any inhaled steroids - No concurrent anticoagulants, except to keep an indwelling line patent - No other concurrent anticancer therapy, including chemotherapy, immunotherapy, radiotherapy, experimental programs, and/or surgery |
Country | Name | City | State |
---|---|---|---|
United States | UPMC Cancer Centers | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Ahmad Tarhini | National Cancer Institute (NCI) |
United States,
Tarhini AA, Leng S, Moschos SJ, Yin Y, Sander C, Lin Y, Gooding WE, Kirkwood JM. Safety and immunogenicity of vaccination with MART-1 (26-35, 27L), gp100 (209-217, 210M), and tyrosinase (368-376, 370D) in adjuvant with PF-3512676 and GM-CSF in metastatic — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety | Number of grade 2 or greater allergic reactions (including generalized urticaria) or any grade 3 or greater adverse event | up to 1 year | |
Secondary | Immunologic response | Change in the circulating effector T-cells. | up to 94 days | |
Secondary | Objective tumor regression | Change in tumor size will be performed at the end of cycle 2. | 2 months | |
Secondary | Depigmentation evaluation | Change in cutaneous depigmentation using careful inspection of the skin of the torso by a Wood's lamp. | up to 2 years |
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