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Vaccine Therapy Using Melanoma Peptides for Cytotoxic T Cells and Helper T Cells in Treating Patients With Metastatic Melanoma
Not Recruiting
Trial ID: NCT00071981
Purpose
RATIONALE: Vaccines made from peptides may make the body build an immune response to kill tumor cells.
PURPOSE: This randomized phase II trial is studying four different vaccines using melanoma peptides from cytotoxic T cells and helper T cells to see how well they work in treating patients with metastatic melanoma.
Official Title
A Randomized Phase II Trial of Multi-Epitope Vaccination With Melanoma Peptides For Cytotoxic T Cells And Helper T Cells For Patients With Metastatic Melanoma
Stanford Investigator(s)
Harlan Pinto
Associate Professor of Medicine (Oncology) and of Otolaryngology - Head & Neck Surgery
Susan M. Swetter, MD
Professor of Dermatology
Eligibility
Inclusion Criteria:
* Histologically confirmed stage IV melanoma
* Multiple primary melanomas allowed
* Metastasis may be from a cutaneous, mucosal, ocular, or unknown primary site
* Measurable disease by Response Evaluation Criteria In Solid Tumors (RECIST criteria)
* Must have 2 extremities uninvolved with tumor
* Must have at least 2 intact (undissected) axillary and/or inguinal lymph node basins
* Prior sentinel node biopsy may not have violated the integrity of a nodal basin
* This extremity may still be considered for vaccination
* Human Lymphocyte Antigen (HLA)-A1, -A2, or -A3 positive
* Prior brain metastases allowed provided all of the following are true:
* Surgically resected or treated with gamma-knife or stereotactic radiosurgery
* No disease progression in the brain for the past 3 months
* More than 30 days since prior steroids for the management of brain metastases
* Age: 18 and over
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* Adequate organ function measured within 4 weeks before randomization:
* White blood cell (WBC) at least 4,000/mm\^3
* Platelet count at least 100,000/mm\^3
* Lymphocyte count at least 700/mm\^3
* Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) no greater than 2 times upper limit of normal (ULN)
* Bilirubin no greater than 2 times ULN
* Alkaline phosphatase no greater than 2 times ULN
* Lactic dehydrogenase no greater than 2 times ULN
* Creatinine no greater than 1.8 mg/dL
* Negative pregnancy test
* Fertile patients must use effective contraception
* No other malignancy within the past 5 years except nonmetastatic squamous cell or basal cell skin cancer, ductal or lobular carcinoma in situ of the breast, or carcinoma in situ of the cervix
* At least 4 weeks since prior sargramostim (GM-CSF), interferon alfa-2b, or interleukin-2
* More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
* More than 30 days since prior systemic corticosteroids, including any of the following:
* Therapeutic doses of oral steroids (e.g., prednisone or dexamethasone)
* Steroid inhalers (e.g., Advair)
* Topical steroids and nasal steroids with low systemic absorption (e.g., fluticasone) or steroids with low systemic absorption (e.g., triamcinolone hexacetonide) injected into a joint space allowed
* At least 4 weeks since prior local control or palliative radiotherapy and recovered
* Recovered from prior major surgery
Exclusion criteria:
* More than 3 brain metastases
* Metastatic lesions greater than 2 cm
* Concurrent radiotherapy
* Prior radiotherapy to measurable disease
* Concurrent surgery
* Concurrent corticosteroids
* Concurrent topical or systemic steroids
* Concurrent chemotherapy
* Prior vaccination with any of the study peptides
* Recent (within the past year) or concurrent addiction to alcohol or illicit drugs
* Pregnant or nursing
* Known or suspected major allergy to any components of the study vaccine
* Significant detectable infection
* Immunosuppression conditions
* Prior or active autoimmune disorder requiring cytotoxic or mmunosuppressive therapy, except for any of the following:
* Presence of laboratory evidence of autoimmune disease (e.g., positive antinuclear antibody (ANA) titer) without symptoms
* Clinical evidence of vitiligo or other forms of depigmenting illness
* Mild arthritis requiring nonsteroidal anti-inflammatory medication
* Autoimmune disorder with visceral involvement
Intervention(s):
biological: incomplete Freund's adjuvant
biological: melanoma helper peptide vaccine
biological: multi-epitope melanoma peptide vaccine
biological: sargramostim
biological: tetanus peptide melanoma vaccine
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-498-7061