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Vaccine Therapy in Treating Patients With Metastatic Melanoma

Primary Purpose

Melanoma (Skin)

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
QS21
IFA (incomplete Freund's adjuvant)
p946
p946/tet-p
Tet-p
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma (Skin) focused on measuring stage II melanoma, stage III melanoma, stage IV melanoma, recurrent melanoma

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cancer Center, University of Virginia HSC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Group 1: peptide 946 plus QS-21

Group 2. p946 plus IFA

Group 3: p946 plus Tet-p plus QS-21

Group 4. p946, Tet-p plus IFA

Group 5: p946/Tet-p plus QS-21

Group 6. p946/Tet-p plus IFA

Arm Description

100 mcg peptide gp100 [280-288] plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant

100 mcg peptide gp100 [280-288] plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant

100 mcg peptide gp100 [280-288],190 mcg tetanus peptide, plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant

100 mcg peptide gp100 [280-288], 190 mcg tetanus peptide, plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant

282 mcg gp100 [280-288]/tetanus peptide conjugate, plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant

282 mcg gp100 [280-288]/tetanus peptide conjugate, plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant

Outcomes

Primary Outcome Measures

Safety: Grade 3 Adverse Events
Adverse events are monitored according to NCI/DCT Common Toxicity Criteria

Secondary Outcome Measures

Immunogenicity of Each Vaccine Regimen
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.

Full Information

First Posted
November 1, 1999
Last Updated
November 18, 2014
Sponsor
University of Virginia
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00003224
Brief Title
Vaccine Therapy in Treating Patients With Metastatic Melanoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
February 1996 (undefined)
Primary Completion Date
August 2000 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma (Skin)
Keywords
stage II melanoma, stage III melanoma, stage IV melanoma, recurrent melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1: peptide 946 plus QS-21
Arm Type
Experimental
Arm Description
100 mcg peptide gp100 [280-288] plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
Arm Title
Group 2. p946 plus IFA
Arm Type
Experimental
Arm Description
100 mcg peptide gp100 [280-288] plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant
Arm Title
Group 3: p946 plus Tet-p plus QS-21
Arm Type
Experimental
Arm Description
100 mcg peptide gp100 [280-288],190 mcg tetanus peptide, plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
Arm Title
Group 4. p946, Tet-p plus IFA
Arm Type
Experimental
Arm Description
100 mcg peptide gp100 [280-288], 190 mcg tetanus peptide, plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant
Arm Title
Group 5: p946/Tet-p plus QS-21
Arm Type
Experimental
Arm Description
282 mcg gp100 [280-288]/tetanus peptide conjugate, plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
Arm Title
Group 6. p946/Tet-p plus IFA
Arm Type
Experimental
Arm Description
282 mcg gp100 [280-288]/tetanus peptide conjugate, plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant
Intervention Type
Biological
Intervention Name(s)
QS21
Intervention Description
vaccine adjuvant
Intervention Type
Biological
Intervention Name(s)
IFA (incomplete Freund's adjuvant)
Other Intervention Name(s)
Montanide ISA-51, from Seppic.
Intervention Description
Peptides emulsified in IFA.
Intervention Type
Biological
Intervention Name(s)
p946
Other Intervention Name(s)
peptide 946, gp100 [280-288], YLEPGPVTA
Intervention Description
This a nonamer peptide YLEPGPVTA from Gp100, used as a melanoma vaccine antigen.
Intervention Type
Biological
Intervention Name(s)
p946/tet-p
Other Intervention Name(s)
peptide 946-tetanus peptide conjugate melanoma vaccine
Intervention Description
This peptide is a longer version of p946 (gp100 [280-288]) sythesized colinearly with the tetanus helper peptide (Tet-p)
Intervention Type
Biological
Intervention Name(s)
Tet-p
Other Intervention Name(s)
tetanus peptide melanoma vaccine
Intervention Description
modified form of the p2 peptide from tetanus toxoid, used as nonspecific epitope for helper T cells.
Primary Outcome Measure Information:
Title
Safety: Grade 3 Adverse Events
Description
Adverse events are monitored according to NCI/DCT Common Toxicity Criteria
Time Frame
Up to 24 months after last vaccine
Secondary Outcome Measure Information:
Title
Immunogenicity of Each Vaccine Regimen
Description
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.
Time Frame
up to 12 months since enrollment
Other Pre-specified Outcome Measures:
Title
Number of Participants With a Proliferative Response to Tetanus Helper Peptide
Description
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.
Time Frame
during vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Craig L. Slingluff, MD
Organizational Affiliation
University of Virginia
Official's Role
Study Chair
Facility Information:
Facility Name
Cancer Center, University of Virginia HSC
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11595689
Citation
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.
Results Reference
result

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Vaccine Therapy in Treating Patients With Metastatic Melanoma

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