NCT00254397

Study of the Modulatory Activity of an LHRH-Agonist (Leuprolide) on Melanoma Peptide Vaccines as Adjuvant Therapy in Melanoma Patients

Completed Phase 2 Results posted Last updated 27 September 2019

What this trial tests

Phase 2 trial testing Leuprolide in Melanoma in 98 participants. Completed in 1 October 2012.

Timeline

1 November 2005

Primary endpoint
1 October 2012

1 October 2012

Quick facts

Lead sponsor	M.D. Anderson Cancer Center
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	98
Start date	1 November 2005
Primary completion	1 October 2012
Estimated completion	1 October 2012
Sites	1 location across United States

Drugs / interventions tested

• Leuprolide (leuprolide) — full drug profile →
• GP100: 209-217(210M) Peptide — full drug profile →
• MAGE-3 Peptide — full drug profile →

Conditions studied

• Melanoma — all drugs for Melanoma →

Sponsor

M.D. Anderson Cancer Center — full company profile →

Who can join

18 and older, any sex, with Melanoma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Number of Participants With T-cell Response to Peptide Vaccine
  Time frame: At 3 months following initial vaccine.
  Reactivity to the gp100 peptide in each participant defined as \>10 tetramer positive cells per 10\^4 CD8+ T-cells as determined by the tetramer analysis at 3 months following initial vaccine. Number of participants with response as defined reported. The primary end point of this clinical study was the comparison of tumor-specific immune responses to melanoma-specific peptide vaccines, gp100 and

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Thymic rejuvenation and aging.
   Ventevogel MS, Sempowski GD. · · 2013 · cited 70× · PMID 23831111 · DOI 10.1016/j.coi.2013.06.002
2. Immunobiology of Uveal Melanoma: State of the Art and Therapeutic Targets.
   Basile MS, Mazzon E, Fagone P, Longo A, et al · · 2019 · cited 42× · PMID 31750244 · DOI 10.3389/fonc.2019.01145
3. How to Make Immunotherapy an Effective Therapeutic Choice for Uveal Melanoma.
   Marseglia M, Amaro A, Solari N, Gangemi R, et al · · 2021 · cited 19× · PMID 33922591 · DOI 10.3390/cancers13092043
4. Inhibition of transplantation tolerance by immune senescence is reversed by endocrine modulation.
   Zhao G, Moore DJ, Kim JI, Lee KM, et al · · 2011 · cited 17× · PMID 21677198 · DOI 10.1126/scitranslmed.3002270
5. Insights into therapeutic peptides in the cancer-immunity cycle: Update and challenges.
   Zhang X, Wu Y, Lin J, Lu S, et al · · 2024 · cited 13× · PMID 39309492 · DOI 10.1016/j.apsb.2024.05.013
6. Peptide Vaccines in Melanoma: Chemical Approaches towards Improved Immunotherapeutic Efficacy.
   Biri-Kovács B, Bánóczi Z, Tummalapally A, Szabó I. · · 2023 · cited 12× · PMID 36839774 · DOI 10.3390/pharmaceutics15020452
7. Sex bias in tumor immunity: insights from immune cells.
   Tao X, Wang Y, Xiang B, Hu D, et al · · 2025 · cited 7× · PMID 40303343 · DOI 10.7150/thno.106465
8. Chemical and Synthetic Biology Approaches for Cancer Vaccine Development.
   Hossain F, Kandalai S, Zhou X, Zhang N, et al · · 2022 · cited 5× · PMID 36296526 · DOI 10.3390/molecules27206933