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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