At a glance
ClinicalIndex Comparison Record- ✓HLA-A*0201 positive
- ✓Stage IIb-IV melanoma, histologically documented, clinically rendered free of disease after surgery
- ✓Uveal melanoma patients following definitive treatment of radiation therapy and/or enucleation
- ✓Age ≥18 years
- ✕Prior systemic therapy, radiation, or surgery requiring general anesthesia for melanoma within 28 days
- ✕Autoimmune diseases
- ✕Concurrent systemic or inhaled steroid therapy
- ✕Active primary or secondary immunodeficiency
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Study of the Modulatory Activity of an LHRH-Agonist (Leuprolide) on Melanoma Peptide Vaccines as Adjuvant Therapy in Melanoma Patients
In Brief
A Phase 2 clinical trial evaluating Leuprolide, GP100: 209-217(210M) Peptide, and 1 other intervention for Melanoma. Completed, enrolled 98 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.