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Sponsored by: |
M.D. Anderson Cancer Center |
Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00254397 |
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:
Condition | Intervention | Phase |
Melanoma |
Drug: Leuprolide Biological: GP100: 209-217(210M) Peptide Biological: MAGE-3 Peptide |
Phase II |
MedlinePlus related topics: | Cancer Melanoma |
Drug Information available for: | Leuprolide acetate Leuprolide Gonadorelin Gonadorelin hydrochloride LH-RH |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Study of the Modulatory Activity of an LHRH-Agonist (Leuprolide) on Melanoma Peptide Vaccines as Adjuvant Therapy in Melanoma Patients |
Estimated Enrollment: | 100 |
Study Start Date: | November 2005 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
HLA-A*0201 positive/HLA-DP4 negative treated with gp100 + Leuprolide
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Drug: Leuprolide
A 3-month 11.25 mg sustained-release formulation will be administrated intramuscularly at time 0, and approximately 12 wks (2 injections).
Biological: GP100: 209-217(210M) Peptide
1.0 ml subcutaneous injection in extremities.
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2: Experimental
HLA-A*0201 positive/HLA-DP4 negative treated with gp100 - No Leuprolide
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Biological: GP100: 209-217(210M) Peptide
1.0 ml subcutaneous injection in extremities.
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3: Experimental
HLA-A*0201positive/HLA-DP4 positive treated with gp100 + MAGE-3 + Leuprolide
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Drug: Leuprolide
A 3-month 11.25 mg sustained-release formulation will be administrated intramuscularly at time 0, and approximately 12 wks (2 injections).
Biological: GP100: 209-217(210M) Peptide
1.0 ml subcutaneous injection in extremities.
Biological: MAGE-3 Peptide
1.0 ml subcutaneous injection in extremities.
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4: Experimental
HLA-A*0201positive/HLA-DP4 positive treated with gp100 + MAGE-3 - No Leuprolide
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Biological: GP100: 209-217(210M) Peptide
1.0 ml subcutaneous injection in extremities.
Biological: MAGE-3 Peptide
1.0 ml subcutaneous injection in extremities.
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The incidence of melanoma is rising in the US. Patients with stage IIb-IV melanoma have significant risk of recurrence after definitive or palliative surgery. With the discovery of numerous antigens for melanoma capable of recognition by T-cells, current goals are focused on defining the best approaches to immunize melanoma patients with these antigens in order to elicit tumor-specific immune responses, and ultimately tumor regression or prevention of disease recurrence. We have previously shown that melanoma patients can be immunized with peptides derived from melanoma associated antigens, such as gp100, resulting in increased numbers of circulating T-cells capable of recognizing the tumor. However, maximum immune response to the vaccines required up to a year of immunizations and new strategies are needed for more efficient vaccination. One potential strategy is to increase thymic activity. T-cells develop in the thymus, which involutes with progressively diminished activity following puberty. This might adversely affect the ability to immunize adults against specific antigens. In addition, aging has been correlated with decreased immune responses against new antigens. Therefore, methods to enhance thymic activity in adults may potentiate antigen-specific immune responses. Ablation of sex steroids has been shown to increase thymic activity. In murine models, surgical castration of aged mice can restore the responsiveness to herpes simplex virus to levels similar to those seen in young mice. Sex steroid ablation by the LHRH-agonist Leuprolide in elderly men for prostate cancer resulted in increased thymic dependent T cell production, particularly naïve (TREC+) CD4+ T cells. Regeneration of adult thymic function by sex steroid ablation therefore may provide a means to improve antitumor T cell immune responses. Our hypothesis is that sex hormone blockade will result in enhanced thymic activity in melanoma patients that will lead to improved anti-tumor T cell responses following antigen-specific immunization.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion:
Exclusion:
Contact: Patrick Hwu, MD | 713-563-1727 | phwu@mdanderson.org |
Contact: Priscilla Miller, RN | 713-563-9445 | pmiller@mdanderson.org |
United States, Texas | |||||
U.T.M.D. Anderson Cancer Center | Recruiting | ||||
Houston, Texas, United States, 77030 | |||||
Principal Investigator: Patrick Hwu, MD |
M.D. Anderson Cancer Center |
Principal Investigator: | Patrick Hwu, MD | U.T.M.D. Anderson Cancer Center |
UT MD Anderson Cancer Center 
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Responsible Party: | U.T.M.D. Anderson Cancer Center ( Patrick Hwu, MD/Professor ) |
Study ID Numbers: | 2004-0502 |
First Received: | November 14, 2005 |
Last Updated: | October 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00254397 |
Health Authority: | United States: Food and Drug Administration |
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