Vaccine Therapy in Treating Patients With Metastatic Melanoma
NCT ID: NCT00003224
Last Updated: 2014-11-20
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
22 participants
INTERVENTIONAL
1996-02-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
PURPOSE: Randomized phase I trial to study the effectiveness of vaccines made from peptide 946 with or without tetanus peptide, QS21, or Montanide ISA-51 in treating patients with metastatic melanoma that cannot be surgically removed or with melanoma that is likely to recur.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
I. Determine the safety of peptide 946 melanoma vaccine (peptide 946), peptide 946 combined with tetanus peptide melanoma vaccine, or peptide 946-tetanus peptide conjugate in patients with high risk melanoma.
II. Determine the immunogenicity of peptide 946 melanoma vaccine (peptide 946), peptide 946 combined with tetanus peptide melanoma vaccine, or peptide 946-tetanus peptide conjugate in patients with high risk melanoma.
OUTLINE: This is a randomized, open-label study. Patients are randomized to 1 of 6 treatment arms: Arm I: Patients receive peptide 946 melanoma vaccine (peptide 946) emulsified with QS21 subcutaneously (SQ). Arm II: Patients receive peptide 946 emulsified with Montanide ISA-51 (ISA-51) SQ. Arm III: Patients receive peptide 946 combined with tetanus peptide melanoma vaccine (tetanus peptide) emulsified with QS21 SQ. Arm IV: Patients receive peptide 946 combined with tetanus peptide emulsified with ISA-51 SQ. Arm V: Patients receive peptide 946-tetanus peptide conjugate emulsified with QS21 SQ. Arm VI: Patients receive peptide 946-tetanus peptide conjugate emulsified with ISA-51 SQ. Initially, 4 patients are randomized to Arm I and 4 patients are randomized to Arm II. If no dose limiting toxicities are observed in these patients, then additional patients are randomized to arms III-VI. Patients in each arm receive vaccine on day 0 and at months 1, 2, 3, 6, 9, and 12. Patients are followed at 6 and 12 months.
PROJECTED ACCRUAL: A maximum of 36 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.
Group 1: peptide 946 plus QS-21
100 mcg peptide gp100 \[280-288\] plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
QS21
vaccine adjuvant
p946
This a nonamer peptide YLEPGPVTA from Gp100, used as a melanoma vaccine antigen.
Group 2. p946 plus IFA
100 mcg peptide gp100 \[280-288\] plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant
IFA (incomplete Freund's adjuvant)
Peptides emulsified in IFA.
p946
This a nonamer peptide YLEPGPVTA from Gp100, used as a melanoma vaccine antigen.
Group 3: p946 plus Tet-p plus QS-21
100 mcg peptide gp100 \[280-288\],190 mcg tetanus peptide, plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
QS21
vaccine adjuvant
p946
This a nonamer peptide YLEPGPVTA from Gp100, used as a melanoma vaccine antigen.
Tet-p
modified form of the p2 peptide from tetanus toxoid, used as nonspecific epitope for helper T cells.
Group 4. p946, Tet-p plus IFA
100 mcg peptide gp100 \[280-288\], 190 mcg tetanus peptide, plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant
IFA (incomplete Freund's adjuvant)
Peptides emulsified in IFA.
p946
This a nonamer peptide YLEPGPVTA from Gp100, used as a melanoma vaccine antigen.
Tet-p
modified form of the p2 peptide from tetanus toxoid, used as nonspecific epitope for helper T cells.
Group 5: p946/Tet-p plus QS-21
282 mcg gp100 \[280-288\]/tetanus peptide conjugate, plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
QS21
vaccine adjuvant
p946/tet-p
This peptide is a longer version of p946 (gp100 \[280-288\]) sythesized colinearly with the tetanus helper peptide (Tet-p)
Group 6. p946/Tet-p plus IFA
282 mcg gp100 \[280-288\]/tetanus peptide conjugate, plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant
IFA (incomplete Freund's adjuvant)
Peptides emulsified in IFA.
p946/tet-p
This peptide is a longer version of p946 (gp100 \[280-288\]) sythesized colinearly with the tetanus helper peptide (Tet-p)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
QS21
vaccine adjuvant
IFA (incomplete Freund's adjuvant)
Peptides emulsified in IFA.
p946
This a nonamer peptide YLEPGPVTA from Gp100, used as a melanoma vaccine antigen.
p946/tet-p
This peptide is a longer version of p946 (gp100 \[280-288\]) sythesized colinearly with the tetanus helper peptide (Tet-p)
Tet-p
modified form of the p2 peptide from tetanus toxoid, used as nonspecific epitope for helper T cells.
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
* Age: 18 to 79
* Performance status: ECOG 0-2
* Life expectancy: Greater than 12 months
* Hematopoietic: Absolute neutrophil count greater than 1,000/mm3 Platelet count greater than 100,000/mm3 Hemoglobin greater than 9 g/dL
* Hepatic: AST and ALT no greater than 2.5 times upper limit of normal (ULN) Bilirubin no greater than 2.5 times ULN Alkaline phosphatase no greater than 2.5 times ULN
* Renal: Creatinine no greater than 1.5 times ULN
Exclusion Criteria
* known or suspected allergies to any component of the treatment vaccine
* unresectable tumor llikely to cause symptoms and for which therapy is anticipated within 3 months.
* receiving acute treatment for seriouis infection within 14 days.
* Patients with bulky disease, or with multiple brain metastases, but solitary brain metastases treated successfully with surgery or gamma knife may be eligible.
* Any of the following with 3 months:
* agentes with putative immunomodulating activity (except NSAIDs)
* allergy desensitizing injections
* other investigational agents
* interferons
* corticosteroids
* any growth factors
* prior melanoma vaccinations
* pregnancy or the possibility of becoming pregnant on study
* medical contraindication or potential problems in complying with the requirements of the protocol.
18 Years
79 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.
Cancer Center, University of Virginia HSC
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, Yamshchikov G, Neese P, Galavotti H, Eastham S, Engelhard VH, Kittlesen D, Deacon D, Hibbitts S, Grosh WW, Petroni G, Cohen R, Wiernasz C, Patterson JW, Conway BP, Ross WG. Phase I trial of a melanoma vaccine with gp100(280-288) peptide and tetanus helper peptide in adjuvant: immunologic and clinical outcomes. Clin Cancer Res. 2001 Oct;7(10):3012-24.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCI-H98-0010
Identifier Type: -
Identifier Source: secondary_id
6346
Identifier Type: -
Identifier Source: org_study_id