- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00028431
Novel Adjuvants for Peptide-Based Melanoma Vaccines
May 20, 2014 updated by: University of Southern California
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
19
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Los Angeles, California, United States, 90089
- Universtiy of Southern California/Kenneth Norris, Jr. Comprehensive Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jeffrey S. Weber, M.D., Ph.D., University of Southern California/Norris Cancer Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2001
Primary Completion (Actual)
January 1, 2003
Study Completion (Actual)
June 1, 2005
Study Registration Dates
First Submitted
January 4, 2002
First Submitted That Met QC Criteria
January 8, 2002
First Posted (Estimate)
January 9, 2002
Study Record Updates
Last Update Posted (Estimate)
May 22, 2014
Last Update Submitted That Met QC Criteria
May 20, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neuroendocrine Tumors
- Nevi and Melanomas
- Melanoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Immunologic Factors
- Antineoplastic Agents, Immunological
- Immune Checkpoint Inhibitors
- Antibodies
- Ipilimumab
Other Study ID Numbers
- FD-R-1975-01
- 10M-00-4;
- FD-R-001975-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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