Phase 2
N=98
Melanoma Vaccine With Peptides and Leuprolide
Melanoma
Bottom Line
View on ClinicalTrials.gov: NCT00254397 ↗Enrolled (actual)
98
Serious AEs
6.1%
Results posted
Oct 2019
Primary outcome: Primary: Number of Participants With T-cell Response to Peptide Vaccine — 6; 1; 12; 19 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Leuprolide (Drug); GP100: 209-217(210M) Peptide (Biological); MAGE-3 Peptide (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Oct 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With T-cell Response to Peptide Vaccine |
6; 1; 12; 19 | — |
| SECONDARY Most Frequent and Most Serious Participant Adverse Events During Vaccine Treatment for Overall Study |
1; 0; 1; 0; 1; 0 | — |
| SECONDARY Number of Participants Experiencing Adverse Events by Maximum Grade Within Different Arms |
0; 0; 1; 0; 2; 0 | — |
| SECONDARY Summary of Adverse Events by Grade/Relationship |
0; 0; 1; 0; 1; 0 | — |
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
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00254397). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.