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

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.

Stanford is currently not accepting patients for this trial.

Stanford Investigator(s):

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

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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting

Our research team includes physicians, residents, medical students, research assistants, and volunteers. Our research topics include medical imaging, device validation,  mobile application development, and pharmaceutical trials.  

Some of the Neuro-Opthalmic concerns we investigate include Multiple Sclerosis, Optic Neuritis, IIH, and ICP.