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Vaccine Therapy in Treating Patients With Metastatic Melanoma

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Craig L Slingluff, Jr, University of Virginia
ClinicalTrials.gov Identifier:
NCT00003224
First received: November 1, 1999
Last updated: November 18, 2014
Last verified: November 2014
  Purpose

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.


Condition Intervention Phase
Melanoma (Skin)
Biological: QS21
Biological: IFA (incomplete Freund's adjuvant)
Biological: p946
Biological: p946/tet-p
Biological: Tet-p
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Protocol for the Evaluation of the Safety and Immunogenicity of Vaccination With a Synthetic Melanoma Peptide in Patients With High Risk Melanoma

Resource links provided by NLM:


Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • Safety: Grade 3 Adverse Events [ Time Frame: Up to 24 months after last vaccine ] [ Designated as safety issue: Yes ]
    Adverse events are monitored according to NCI/DCT Common Toxicity Criteria


Secondary Outcome Measures:
  • Immunogenicity of Each Vaccine Regimen [ Time Frame: up to 12 months since enrollment ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Number of Participants With a Proliferative Response to Tetanus Helper Peptide [ Time Frame: during vaccination ] [ Designated as safety issue: No ]
    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.


Enrollment: 22
Study Start Date: February 1996
Primary Completion Date: August 2000 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1: peptide 946 plus QS-21
100 mcg peptide gp100 [280-288] plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
Biological: QS21
vaccine adjuvant
Biological: p946
This a nonamer peptide YLEPGPVTA from Gp100, used as a melanoma vaccine antigen.
Other Name: peptide 946, gp100 [280-288], YLEPGPVTA
Experimental: Group 2. p946 plus IFA
100 mcg peptide gp100 [280-288] plus 0.5 ml IFA (Montanide ISA-51) 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
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
Biological: QS21
vaccine adjuvant
Biological: p946
This a nonamer peptide YLEPGPVTA from Gp100, used as a melanoma vaccine antigen.
Other Name: peptide 946, gp100 [280-288], YLEPGPVTA
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 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
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: 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 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
Biological: QS21
vaccine adjuvant
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
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
Biological: IFA (incomplete Freund's adjuvant)
Peptides emulsified in IFA.
Other Name: Montanide ISA-51, from Seppic.
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003224

Locations
United States, Virginia
Cancer Center, University of Virginia HSC
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
University of Virginia
Investigators
Study Chair: Craig L. Slingluff, MD University of Virginia
  More Information

Additional Information:
Publications:
Responsible Party: Craig L Slingluff, Jr, Professor of Surgery, University of Virginia
ClinicalTrials.gov Identifier: NCT00003224     History of Changes
Other Study ID Numbers: 6346, NCI-H98-0010
Study First Received: November 1, 1999
Results First Received: January 22, 2013
Last Updated: November 18, 2014
Health Authority: United States: Federal Government

Keywords provided by University of Virginia:
stage II melanoma
stage III melanoma
stage IV melanoma
recurrent melanoma

Additional relevant MeSH terms:
Melanoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas
Freund's Adjuvant
QS 21
Adjuvants, Immunologic
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014