Status:
COMPLETED
Melanoma Vaccine With Peptides and Leuprolide
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 me...
Detailed Description
This study uses vaccines named gp100 or MAGE-3 to immunize patients with melanoma. The type of melanoma they will be used for contains a protein that is also found in the vaccines. These vaccines are ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT00254397
Start Date
November 1 2005
End Date
October 1 2012
Last Update
October 16 2019
Active Locations (1)
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1
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030