Melanoma Vaccine With Peptides and Leuprolide

Completed · Phase 2

Conditions studied: Melanoma

In brief

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.

Key facts

Study ID

NCT00254397

Run by

M.D. Anderson Cancer Center

People needed

98

Starts

2005-11-01

Expected to finish

2012-10-01

Last updated by the study team

2019-10-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• HLA-A *0201 positive
• Patients >/= 18 years old with histologically documented diagnosis of stage IIb-IV melanomas and are clinically rendered free of disease after surgery
• Uveal melanoma patients following definitive treatment of radiation therapy and/or enucleation.
• Karnofsky Performance Scale >/= 60%.
• White Blood Count (WBC) >/= 3000/mm\^3.
• Platelet count >/= 90,000mm\^3.
• Serum creatinine </= 2.0mg/dl.
• Serum alanine aminotransferase (ALT) </= 3 times upper limit of normal(ULN))
• 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.
• 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.)
• Negative pregnancy test by serum or urine b-HCG test for women who have menstruation in the past 12 months and without sterilization surgery.
• 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.

You may not qualify if…

• Prior systemic therapy (including immunomodulate agents), radiation or surgery requiring general anesthesia for melanoma within 28 days of starting study treatment.
• Autoimmune diseases.
• Concurrent systemic or inhaled steroid therapy.
• Any form of active primary or secondary immunodeficiency.
• History of immunization with gp100 or MAGE-3.
• 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.
• Received a Luteinizing hormone-releasing hormone (LHRH) agonist within the past 5 years.
• Use of oral contraceptive, hormone replacement therapy or androgen preparations.
• Hypersensitivity to gonadotropin-releasing hormone analogues.
• Active systemic infections requiring intravenous antibiotics.
• Lactating women or women planning lactation during the study.

Where it is running

• UT MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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