Vaccine Therapy Using Melanoma Peptides for Cytotoxic T Cells and Helper T Cells in Treating Patients With Metastatic Melanoma

Not Recruiting

Trial ID: NCT00071981


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
Harlan Pinto

Associate Professor of Medicine (Oncology) and of Otolaryngology - Head & Neck Surgery

Susan M. Swetter, MD
Susan M. Swetter, MD

Professor of Dermatology


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

   - 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

      - 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


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

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