Vaccine Therapy in Treating Patients With Metastatic Melanoma
Phase I Protocol for the Evaluation of the Safety and Immunogenicity of Vaccination With a Synthetic Melanoma Peptide in Patients With High Risk Melanoma
2 other identifiers
interventional
22
1 country
1
Brief Summary
RATIONALE: Vaccines made from peptide 946 may make the body build an immune response to kill tumor cells. Combining these vaccines with proteins from the tetanus vaccine, and/or with either QS21 or Montanide ISA-51 may be an effective treatment for metastatic melanoma. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 1996
CompletedFirst Submitted
Initial submission to the registry
November 1, 1999
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2000
CompletedFirst Posted
Study publicly available on registry
August 25, 2004
CompletedResults Posted
Study results publicly available
November 20, 2014
CompletedNovember 20, 2014
November 1, 2014
4.5 years
November 1, 1999
January 22, 2013
November 18, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety: Grade 3 Adverse Events
Adverse events are monitored according to NCI/DCT Common Toxicity Criteria
Up to 24 months after last vaccine
Secondary Outcomes (1)
Immunogenicity of Each Vaccine Regimen
up to 12 months since enrollment
Other Outcomes (1)
Number of Participants With a Proliferative Response to Tetanus Helper Peptide
during vaccination
Study Arms (6)
Group 1: peptide 946 plus QS-21
EXPERIMENTAL100 mcg peptide gp100 \[280-288\] plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
Group 2. p946 plus IFA
EXPERIMENTAL100 mcg peptide gp100 \[280-288\] plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant
Group 3: p946 plus Tet-p plus QS-21
EXPERIMENTAL100 mcg peptide gp100 \[280-288\],190 mcg tetanus peptide, plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
Group 4. p946, Tet-p plus IFA
EXPERIMENTAL100 mcg peptide gp100 \[280-288\], 190 mcg tetanus peptide, plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant
Group 5: p946/Tet-p plus QS-21
EXPERIMENTAL282 mcg gp100 \[280-288\]/tetanus peptide conjugate, plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
Group 6. p946/Tet-p plus IFA
EXPERIMENTAL282 mcg gp100 \[280-288\]/tetanus peptide conjugate, plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant
Interventions
vaccine adjuvant
Peptides emulsified in IFA.
This a nonamer peptide YLEPGPVTA from Gp100, used as a melanoma vaccine antigen.
This peptide is a longer version of p946 (gp100 \[280-288\]) sythesized colinearly with the tetanus helper peptide (Tet-p)
modified form of the p2 peptide from tetanus toxoid, used as nonspecific epitope for helper T cells.
Eligibility Criteria
You may qualify if:
- Histologically confirmed unresectable metastatic melanoma (AJCC stage III or IV) OR resected melanoma with high risk of recurrence or mortality (stage IIB and above)
- 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
You may not qualify if:
- patients currently receiving cytotoxic chemotherapy or who have received that therapy within the preceding 3 months
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Virginialead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Cancer Center, University of Virginia HSC
Charlottesville, Virginia, 22908, United States
Related Publications (1)
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.
PMID: 11595689RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Craig Slingluff
- Organization
- University of Virginia
Study Officials
- STUDY CHAIR
Craig L. Slingluff, MD
University of Virginia
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Surgery
Study Record Dates
First Submitted
November 1, 1999
First Posted
August 25, 2004
Study Start
February 1, 1996
Primary Completion
August 1, 2000
Last Updated
November 20, 2014
Results First Posted
November 20, 2014
Record last verified: 2014-11