Melanoma Vaccine With Peptides and Leuprolide
Condition: Melanoma
MeSH terms: Melanoma
Intervention: Leuprolide; GP100: 209-217(210M) Peptide; MAGE-3 Peptide
Intervention description: A 3-month 11.25 mg sustained-release formulation will be administrated intramuscularly at time 0, and approximately 12 weeks (2 injections).; 1.0 ml subcutaneous injection in extremities.; 1.0 ml subcutaneous injection in extremities.
Intervention MeSH terms: Leuprolide
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 98.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Melanoma; Uveal Melanoma; Peptide Vaccine; LHRH-agonist; Leuprolide; Lupron; MAGE-3 Peptide; MAGE-3; GP100 Peptide; Melanoma vaccines; Tumor fighting immune cells; T cells; Skin Cancer; Eye Cancer

Summary:

      The goal of this clinical research study is to learn if the drug leuprolide will increase the
      level of immune cells in your body. Researchers will also want to know if this drug given
      together with melanoma vaccines (gp100 and MAGE-3) can improve the ability of tumor fighting
      immune cells (T cells) to fight melanoma cells.

      Primary Objective:

      1. To compare the tumor-specific immune responses to melanoma-specific peptide vaccines,
      gp100 and MAGE-3 in the presence or absence of a luteinizing hormone-releasing hormone (LHRH)
      agonist-Leuprolide, in patients with stage IIb and III melanoma, uveal melanoma or stage IV
      melanoma that the metastatic lesion(s) has been surgically removed.

      Secondary Objectives:

        1. To evaluate the kinetics of enhanced thymic activity measured by TREC analysis and flow
           cytometric analysis following sex hormone ablation by Leuprolide in melanoma patients.

        2. To assess whether there are significant differences in overall quality of life (QOL)
           between patients receiving Leuprolide to those not receiving leuprolide.
    

Eligibility criteria:

        Inclusion Criteria:

          1. HLA-A *0201 positive

          2. Patients >/= 18 years old with histologically documented diagnosis of stage IIb-IV
             melanomas and are clinically rendered free of disease after surgery

          3. Uveal melanoma patients following definitive treatment of radiation therapy and/or
             enucleation.

          4. Karnofsky Performance Scale >/= 60%.

          5. White Blood Count (WBC) >/= 3000/mm^3.

          6. Platelet count >/= 90,000mm^3.

          7. Serum creatinine </= 2.0mg/dl.

          8. Serum alanine aminotransferase (ALT) </= 3 times upper limit of normal(ULN))

          9. Total bilirubin equal or less than 2 times upper limit of normal (ULN)), except for
             patient with Gilbert's syndrome who must have a total bilirubin less than 3.0mg/dl.

         10. Seronegative for HIV antibody. (The experimental treatment being evaluated in this
             protocol depends on an intact immune system. Patients who are HIV seropositive can
             have decreased immune competence and thus be less responsive to the experimental
             treatment and more susceptible to its toxicities.)

         11. Negative pregnancy test by serum or urine b-HCG test for women who have menstruation
             in the past 12 months and without sterilization surgery.

         12. Unless surgically sterile by bilateral tubal-ligation or vasectomy of partner(s), the
             subject agrees to continue to use a barrier method of contraception throughout the
             study such as: condom, or diaphragm, or sponge plus spermicide. Abstinence is an
             acceptable form of birth control.

        Exclusion Criteria:

          1. Prior systemic therapy (including immunomodulate agents), radiation or surgery
             requiring general anesthesia for melanoma within 28 days of starting study treatment.

          2. Autoimmune diseases.

          3. Concurrent systemic or inhaled steroid therapy.

          4. Any form of active primary or secondary immunodeficiency.

          5. History of immunization with gp100 or MAGE-3.

          6. Prior malignancy except for the following: adequately treated basal cell or squamous
             cell skin cancer, in-situ cervical cancer, surgically treated Stage I or II cancer
             from which the patient is currently in complete remission (at least for 5 years), or
             any other cancer from which the patient has been disease-free for 5 years.

          7. Received a Luteinizing hormone-releasing hormone (LHRH) agonist within the past 5
             years.

          8. Use of oral contraceptive, hormone replacement therapy or androgen preparations.

          9. Hypersensitivity to gonadotropin-releasing hormone analogues.

         10. Active systemic infections requiring intravenous antibiotics.

         11. Lactating women or women planning lactation during the study.