Melanoma Vaccine With Peptides and Leuprolide

What Was Tested

In this phase 2 trial, researchers set out to test Leuprolide.

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.

It had four arms (groups): gp100 + Leuprolide (experimental), gp100 - No Leuprolide (experimental), gp100 + MAGE-3 + Leuprolide (experimental) and gp100 + MAGE-3 - No Leuprolide (experimental).

The registry classes the interventions as biological and drug.

More on the Plan

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 designed to stimulate immune cells, also called T cells, to recognize and kill melanoma cells.

If you are eligible for this treatment, you will be assigned to one of the two groups that either receive one vaccine or two different vaccines, depending on your tissue type (either gp100 vaccine alone or gp100 and MAGE-3 vaccines).

Who Took Part

The registry lists 98 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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. White Blood Count (WBC) \>/= 3000/mm\^3. Platelet count \>/= 90,000mm\^3.

The full record lists 12 inclusion and 11 exclusion criteria; among the exclusions: 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.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

The participants were allocated by chance, so the Leuprolide group and the comparison group should start out alike.

The Leuprolide group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Leuprolide study: the participants and staff both knew the treatment.

It started in 2005-11 with completion listed for 2012-10.

It ran at 1 site in United States.

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: Number of Participants With T-cell Response to Peptide Vaccine (time frame: At 3 months following initial vaccine).

It also tracked 3 secondary outcomes, for example Most Frequent and Most Serious Participant Adverse Events During Vaccine Treatment for Overall Study, Number of Participants Experiencing Adverse Events by Maximum Grade Within Different Arms and Summary of Adverse Events by Grade/Relationship.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Leuprolide in 98 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Leuprolide compound page, all human trials.