Vaccine Therapy in Treating Patients With Stage IIIB, Stage IIIC, or Stage IV Melanoma
NCT ID: NCT00089219
Last Updated: 2014-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1/PHASE2
39 participants
INTERVENTIONAL
2003-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
PURPOSE: This randomized phase I/II trial is studying three different doses of a vaccine and comparing them to see how well they work in treating patients with stage IIIB, stage IIIC, or stage IV melanoma.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* Determine the immune response in patients with stage IIIB, IIIC, or IV melanoma treated with vaccine comprising multiple synthetic melanoma peptides, Montanide ISA-51, and sargramostim (GM-CSF).
OUTLINE: This is a randomized study. Patients are randomized to 1 of 3 treatment arms.
* Arm I: Patients receive vaccine comprising low-dose multiple synthetic melanoma peptides, Montanide ISA-51, and sargramostim (GM-CSF) on days 1, 8, 15, 29, 36, and 43.
* Arm II: Patients receive vaccine comprising medium-dose multiple synthetic melanoma peptides, Montanide ISA-51, and GM-CSF as in arm I.
* Arm III: Patients receive vaccine comprising high-dose multiple synthetic melanoma peptides, Montanide ISA-51, and GM-CSF as in arm I.
On day 22, the lymph node draining the vaccination site is removed to determine whether the immune system is responding to the vaccine.
PROJECTED ACCRUAL: A maximum of 38 patients will be accrued for this study.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm A. 6MHP vaccine 200 mcg
vaccine containing 6 melanoma helper peptides, at 200 mcg per peptide, with GM-CSF and IFA (Montanide ISA-51)
IFA
vaccine adjuvant
6MHP
melanoma helper peptides
GM-CSF
vaccine adjuvant
Arm B. 6MHP vaccine 400 mcg
vaccine containing 6 melanoma helper peptides, at 400 mcg per peptide, with GM-CSF and IFA (Montanide ISA-51)
IFA
vaccine adjuvant
6MHP
melanoma helper peptides
GM-CSF
vaccine adjuvant
Arm C. 6MHP vaccine 800 mcg
vaccine containing 6 melanoma helper peptides, at 800 mcg per peptide, with GM-CSF and IFA (Montanide ISA-51)
IFA
vaccine adjuvant
6MHP
melanoma helper peptides
GM-CSF
vaccine adjuvant
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
IFA
vaccine adjuvant
6MHP
melanoma helper peptides
GM-CSF
vaccine adjuvant
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Diagnosis of stage IIIB, IIIC, or IV melanoma
* HLA-DR1, -DR4, -DR11, -DR13, or -DR15 positive
* Brain metastases allowed at the discretion of the principle investigator
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-1
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count \> 1,000/mm\^3
* Platelet count \> 100,000/mm \^3
* Hemoglobin \> 9 g/dL
Hepatic
* Liver function tests ≤ 2.5 times upper limit of normal (ULN)
Renal
* Creatinine ≤ 1.5 times ULN
Cardiovascular
* No New York Heart Association class III or IV heart disease
Other
* Prior diagnosis of other cancer allowed
* Not pregnant or nursing
* Weight ≥ 110 pounds
* No uncontrolled diabetes
PRIOR CONCURRENT THERAPY:
Biologic therapy
* More than 4 weeks since prior growth factors
* More than 4 weeks since prior allergy shots
* More than 12 weeks since prior melanoma vaccine therapy\* NOTE: \*Prior melanoma vaccine allowed only for patients with disease progression during or after administration of the vaccine
* No prior vaccination with any of the peptides used in this study
Chemotherapy
* More than 4 weeks since prior chemotherapy
Endocrine therapy
* More than 4 weeks since prior steroids
Radiotherapy
* More than 4 weeks since prior radiotherapy
Surgery
* Not specified
Other
* More than 1 month since prior investigational drugs or therapies
* No other concurrent investigational drugs or therapies
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
University of Virginia
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Craig L Slingluff, Jr
Professor of Surgery
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Craig L. Slingluff, MD
Role: STUDY_CHAIR
University of Virginia
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Virginia Cancer Center
Charlottesville, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Slingluff CL Jr, Petroni GR, Olson W, Czarkowski A, Grosh WW, Smolkin M, Chianese-Bullock KA, Neese PY, Deacon DH, Nail C, Merrill P, Fink R, Patterson JW, Rehm PK. Helper T-cell responses and clinical activity of a melanoma vaccine with multiple peptides from MAGE and melanocytic differentiation antigens. J Clin Oncol. 2008 Oct 20;26(30):4973-80. doi: 10.1200/JCO.2008.17.3161. Epub 2008 Sep 22.
Shukla GS, Olson WC, Pero SC, Sun YJ, Carman CL, Slingluff CL Jr, Krag DN. Vaccine-draining lymph nodes of cancer patients for generating anti-cancer antibodies. J Transl Med. 2017 Aug 29;15(1):180. doi: 10.1186/s12967-017-1283-8.
Dillon PM, Olson WC, Czarkowski A, Petroni GR, Smolkin M, Grosh WW, Chianese-Bullock KA, Deacon DH, Slingluff CL Jr. A melanoma helper peptide vaccine increases Th1 cytokine production by leukocytes in peripheral blood and immunized lymph nodes. J Immunother Cancer. 2014 Jul 15;2:23. doi: 10.1186/2051-1426-2-23. eCollection 2014.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
UVACC-MEL-41
Identifier Type: -
Identifier Source: secondary_id
UVACC-28502
Identifier Type: -
Identifier Source: secondary_id
10464
Identifier Type: -
Identifier Source: org_study_id