Vaccine Therapy in Treating Patients With Stage IIC-IV Melanoma

Completed · Phase 2

Conditions studied: Ciliary Body and Choroid Melanoma, Medium/Large Size, Ciliary Body and Choroid Melanoma, Small Size, Extraocular Extension Melanoma, Iris Melanoma, Metastatic Intraocular Melanoma, Mucosal Melanoma, Recurrent Intraocular Melanoma, Recurrent Melanoma, Stage IIC Melanoma, Stage IIIA Intraocular Melanoma, Stage IIIA Melanoma, Stage IIIB Intraocular Melanoma, Stage IIIB Melanoma, Stage IIIC Intraocular Melanoma, Stage IIIC Melanoma, Stage IV Intraocular Melanoma, Stage IV Melanoma

In brief

This pilot phase II trial studies how well giving vaccine therapy works in treating patients with stage IIC-IV melanoma. Vaccines made from melanoma peptides or antigens may help the body build an effective immune response to kill tumor cells

Key facts

Study ID: NCT00085189
Run by: University of Southern California
People needed: 42
Starts: 2004-05-01
Expected to finish: 2007-09-01
Last updated by the study team: 2014-05-22

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Stages IIC, III and IV cutaneous, or mucosal melanoma or stages III/IV ocular melanoma that have been completely resected; those rendered disease-free by radiation or systemic chemotherapy and/or immune therapy will also be eligible; patients must be entered within 12 months of disease-free status
Patients must be positive for at least one of human leukocyte antigen (HLA) A1, A3/A11 typed by a standard deoxyribonucleic acid (DNA)-polymerase chain reaction (PCR) assay, and HLA-B44 status must be known; patients who are B44 positive but do not express A1, A3 or A11 are not eligible for this trial
Tumor tissue must be available for analysis of gp100 and tyrosinase expression by immunohistochemistry; positive staining for at least one antigen will be an eligibility criteria for this trial
Serum creatinine of 2.0 mg/dl or less
Total bilirubin of 2.0 mg/dl or less
Serum glutamic oxaloacetic transaminase (SGOT)/serum glutamate pyruvate transaminase (SGPT) of 2.5 X institutional norm or less
Total white blood cell (WBC) of 3,000 or more
At least 1500 granulocytes
Hemoglobin of 9.0 gm/dl
Platelet count of 100,000 per cu mm
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Patients will be eligible for this trial if they have failed alpha-interferon, if it is felt to be contraindicated due to a pre-existing medical or psychiatric condition or if they have refused treatment with it
Ability to read, understand and willingness to sign an institutional review board (IRB)-approved informed consent

You may not qualify if…

Who are undergoing or have undergone in the past month any other therapy for their cancer, including radiation therapy and adjuvant therapy; six weeks must have elapsed for nitrosoureas
Have major systemic infections like pneumonia or sepsis, coagulation or bleeding disorders, or other major medical illnesses of the gastrointestinal, cardiovascular or respiratory systems
Who require steroid therapy or have been treated with steroids within 4 weeks of starting the trial
Who are pregnant or lactating, since the risk of autoimmune reactivity to tyrosinase or gp100 is felt to present a risk to the fetus or a breast feeding infant
Who are known to be positive for hepatitis B surface antigen (BsAg), Hepatitis C antibody or human immunodeficiency virus (HIV) antibody; since cells removed for ex vivo handling and tissue culture cannot be virus positive, and the effects of 7909 might be detrimental to HIV positive patients, patients positive for the above viruses will not be treated on this trial
Who have had a known allergic reaction to Montanide ISA 51 or ISA 51 VG
Who have a prior history of uveitis, autoimmune inflammatory eye disease or other autoimmune diseases other than vitiligo or controlled thyroiditis
Who have had another malignancy within the last three years with the exception of squamous or basal carcinoma of the skin or carcinoma in situ of the cervix that have been treated with curative intent
Who have previously received any of the peptides in the vaccine

Where it is running

University of Southern California — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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