search
Back to results

Novel Adjuvants for Peptide-Based Melanoma Vaccines

Primary Purpose

Melanoma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
MDX-CTLA4 Antibody; Tyrosinase/gp100/MART-1 Peptides Melanoma Vaccine
Sponsored by
University of Southern California
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma focused on measuring Stage III melanoma, Stage IV melanoma, Interleukin-12, Cancer Vaccines, Antineoplastic Agents, Combined, Incomplete Freund's adjuvant, Monophenol Monooxygenase, Mannitol, Adjuvants, Immunologic, Melan-A Protein, Antigens, Neoplasm, Antibodies, Melanocyte lineage-specific antigen gp100, CTLA-4

Eligibility Criteria

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

Inclusion criteria: Diagnosis of stage III or IV cutaneous, mucosal, or ocular melanoma Completely resected disease or disease-free HLA-A2.1 positive Tumor tissue available for immunohistochemical analysis and staining positive for at least 1 of the specified antigens At least 1 month since prior therapy for cancer, including radiotherapy and adjuvant therapy WBC count at least 3,000/mm3 Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9.0 gm/dL Creatinine no greater than 2.0 mg/dL Bilirubin no greater than 2.0 mg/dL SGOT/SGPT no greater than 2.5 times upper limit of normal ECOG performance status 0-1 Have failed alpha-interferons (patients with resected stage III disease) Exclusion criteria: Prior treatment with tyrosinase: 368-376(370D), gp100:209-217(210M), and MART-1:26-35(27L) peptides Steroid therapy or other immunosuppressive medication requirement Major systemic infections (e.g., pneumonia or sepsis) Coagulation or bleeding disorders Major medical illnesses of the gastrointestinal, cardiovascular, or respiratory systems Allergic reaction to Montanide ISA 51 (incomplete Freund's adjuvant) History of uveitis or autoimmune inflammatory eye disease Other active autoimmune disease Positive for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody Pregnant or nursing

Sites / Locations

  • Universtiy of Southern California/Kenneth Norris, Jr. Comprehensive Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 4, 2002
Last Updated
May 20, 2014
Sponsor
University of Southern California
search

1. Study Identification

Unique Protocol Identification Number
NCT00028431
Brief Title
Novel Adjuvants for Peptide-Based Melanoma Vaccines
Official Title
An Open Label Study of MDX-CTLA4 in Combination With Tyrosinase/gp100/MART-1 Peptides Emulsified With Montanide ISA 51 in the Treatment of Patients With Resected Stage III or IV Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
August 2001 (undefined)
Primary Completion Date
January 2003 (Actual)
Study Completion Date
June 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southern California

4. Oversight

5. Study Description

Brief Summary
This is a study to determine the efficacy of a melanoma vaccine chemotherapy cocktail composed of CTLA-4 antibody; tyrosinase, gp100, and MART-1 peptides; and incomplete Freund's adjuvant (IFA) with or without interleukin-12 in patients with resected stage III or IV melanoma.
Detailed Description
In the Phase I/II trial, patients with resected stages III and IV melanoma who have been rendered free of disease, but are at high risk of relapse, are treated with peptides/IFA at a dose of 0.5 mg each peptide plus CTLA-4 antibody given intravenously, 3 mg/kg, after each vaccination. In the Phase II randomized study, patients are treated with the melanoma peptide vaccine alone, with CTLA-4 antibody, or with CTLA-4 antibody combined with IL-12 at 30 ng/kg with alum. The peptides are tyrosinase 368-376 (370D); gp100 209-217 (210M); and MART-1 26-35 (27L) which are emulsified with IFA. The dosing schedule for both trials are at 1, 2, 3, 4, 5, and 6 months; then at 9 and 12 for a total of 8 vaccinations.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma
Keywords
Stage III melanoma, Stage IV melanoma, Interleukin-12, Cancer Vaccines, Antineoplastic Agents, Combined, Incomplete Freund's adjuvant, Monophenol Monooxygenase, Mannitol, Adjuvants, Immunologic, Melan-A Protein, Antigens, Neoplasm, Antibodies, Melanocyte lineage-specific antigen gp100, CTLA-4

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
MDX-CTLA4 Antibody; Tyrosinase/gp100/MART-1 Peptides Melanoma Vaccine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Diagnosis of stage III or IV cutaneous, mucosal, or ocular melanoma Completely resected disease or disease-free HLA-A2.1 positive Tumor tissue available for immunohistochemical analysis and staining positive for at least 1 of the specified antigens At least 1 month since prior therapy for cancer, including radiotherapy and adjuvant therapy WBC count at least 3,000/mm3 Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9.0 gm/dL Creatinine no greater than 2.0 mg/dL Bilirubin no greater than 2.0 mg/dL SGOT/SGPT no greater than 2.5 times upper limit of normal ECOG performance status 0-1 Have failed alpha-interferons (patients with resected stage III disease) Exclusion criteria: Prior treatment with tyrosinase: 368-376(370D), gp100:209-217(210M), and MART-1:26-35(27L) peptides Steroid therapy or other immunosuppressive medication requirement Major systemic infections (e.g., pneumonia or sepsis) Coagulation or bleeding disorders Major medical illnesses of the gastrointestinal, cardiovascular, or respiratory systems Allergic reaction to Montanide ISA 51 (incomplete Freund's adjuvant) History of uveitis or autoimmune inflammatory eye disease Other active autoimmune disease Positive for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody Pregnant or nursing
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey S. Weber, M.D., Ph.D.
Organizational Affiliation
University of Southern California/Norris Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universtiy of Southern California/Kenneth Norris, Jr. Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90089
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Novel Adjuvants for Peptide-Based Melanoma Vaccines

We'll reach out to this number within 24 hrs