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Vaccine Therapy in Treating Patients With Metastatic Melanoma

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ClinicalTrials.gov Identifier: NCT00003224
Recruitment Status : Completed
First Posted : August 25, 2004
Results First Posted : November 20, 2014
Last Update Posted : November 20, 2014
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Craig L Slingluff, Jr, University of Virginia

November 1, 1999
August 25, 2004
January 22, 2013
November 20, 2014
November 20, 2014
February 1996
August 2000   (Final data collection date for primary outcome measure)
Safety: Grade 3 Adverse Events [ Time Frame: Up to 24 months after last vaccine ]
Adverse events are monitored according to NCI/DCT Common Toxicity Criteria
Not Provided
Complete list of historical versions of study NCT00003224 on ClinicalTrials.gov Archive Site
Immunogenicity of Each Vaccine Regimen [ Time Frame: up to 12 months since enrollment ]
T cell responses to the p946 (gp100 [280-288]) peptide. All enrolled patients were assayed for immune response to the gp100 peptide by ELIspot assay after 14 days in vitro sensitization. The number with a response in each study arm is reported.
Not Provided
Number of Participants With a Proliferative Response to Tetanus Helper Peptide [ Time Frame: during vaccination ]
Proliferative response measured in participants using a tritiated thymidine incorporation assay with peripheral blood mononuclear cells (PBMC) stimulated with the tetanus peptide in vitro, and measured at 5 days after in vitro culture.
Not Provided
 
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

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.

OBJECTIVES:

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.

Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Melanoma (Skin)
  • Biological: QS21
    vaccine adjuvant
  • Biological: IFA (incomplete Freund's adjuvant)
    Peptides emulsified in IFA.
    Other Name: Montanide ISA-51, from Seppic.
  • Biological: p946
    This a nonamer peptide YLEPGPVTA from Gp100, used as a melanoma vaccine antigen.
    Other Name: peptide 946, gp100 [280-288], YLEPGPVTA
  • Biological: p946/tet-p
    This peptide is a longer version of p946 (gp100 [280-288]) sythesized colinearly with the tetanus helper peptide (Tet-p)
    Other Name: peptide 946-tetanus peptide conjugate melanoma vaccine
  • Biological: Tet-p
    modified form of the p2 peptide from tetanus toxoid, used as nonspecific epitope for helper T cells.
    Other Name: tetanus peptide melanoma vaccine
  • Experimental: Group 1: peptide 946 plus QS-21
    100 mcg peptide gp100 [280-288] plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
    Interventions:
    • Biological: QS21
    • Biological: p946
  • Experimental: Group 2. p946 plus IFA
    100 mcg peptide gp100 [280-288] plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant
    Interventions:
    • Biological: IFA (incomplete Freund's adjuvant)
    • Biological: p946
  • Experimental: 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
    Interventions:
    • Biological: QS21
    • Biological: p946
    • Biological: Tet-p
  • Experimental: 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
    Interventions:
    • Biological: IFA (incomplete Freund's adjuvant)
    • Biological: p946
    • Biological: Tet-p
  • Experimental: 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
    Interventions:
    • Biological: QS21
    • Biological: p946/tet-p
  • Experimental: 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
    Interventions:
    • Biological: IFA (incomplete Freund's adjuvant)
    • Biological: p946/tet-p
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
Not Provided
Not Provided
August 2000   (Final data collection date for primary outcome measure)

Inclusion criteria:

  • 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

Exclusion criteria:

  • 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.
Sexes Eligible for Study: All
18 Years to 79 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00003224
6346
NCI-H98-0010
Yes
Not Provided
Not Provided
Craig L Slingluff, Jr, University of Virginia
University of Virginia
National Cancer Institute (NCI)
Study Chair: Craig L. Slingluff, MD University of Virginia
University of Virginia
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP