Novel Adjuvants for Peptide-Based Melanoma Vaccines
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2001 by FDA Office of Orphan Products Development.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Information provided by:
FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:
NCT00028431
First received: January 4, 2002
Last updated: June 23, 2005
Last verified: December 2001
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Melanoma |
Biological: MDX-CTLA4 Antibody; Tyrosinase/gp100/MART-1 Peptides Melanoma Vaccine |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by FDA Office of Orphan Products Development:
| Estimated Enrollment: | 72 |
| Study Start Date: | July 2001 |
| Estimated Study Completion Date: | June 2004 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00028431
Locations
| United States, California | |
| Universtiy of Southern California/Kenneth Norris, Jr. Comprehensive Cancer Center | Recruiting |
| Los Angeles, California, United States, 90089 | |
| Contact: Jeffrey S Weber, M.D., Ph.D. 323-865-3919 jweber@hsc.usc.edu | |
Sponsors and Collaborators
Investigators
| Principal Investigator: | Jeffrey S. Weber, M.D., Ph.D. | University of Southern California/Norris Cancer Center |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00028431 History of Changes |
| Other Study ID Numbers: | FD-R-1975-01, 10M-00-4;, FD-R-001975-01 |
| Study First Received: | January 4, 2002 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by FDA Office of Orphan Products Development:
|
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 |
Additional relevant MeSH terms:
|
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas Adjuvants, Immunologic |
Antibodies Cytotoxic T-lymphocyte antigen 4 Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Immunosuppressive Agents |
ClinicalTrials.gov processed this record on May 16, 2013