Melanoma Vaccine With Peptides and Leuprolide - Full Text View

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00254397

Purpose

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:

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.
To assess whether there are significant differences in overall quality of life (QOL) between patients receiving Leuprolide to those not receiving leuprolide.

Condition	Intervention	Phase
Melanoma	Drug: Leuprolide Biological: GP100: 209-217(210M) Peptide Biological: MAGE-3 Peptide	Phase II

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Melanoma

Drug Information available for: Leuprolide Leuprolide acetate

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

To learn if the drug leuprolide will increase the level of immune cells in your body. [ Time Frame: 4 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To learn 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. [ Time Frame: 4 Years ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	November 2005
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Group IA: HLA-A*0201 positive/HLA-DP4 negative treated with gp100 + Leuprolide	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.
2: Experimental Group IB: HLA-A*0201 positive/HLA-DP4 negative treated with gp100 - No Leuprolide	Biological: GP100: 209-217(210M) Peptide 1.0 ml subcutaneous injection in extremities.
3: Experimental Group IIA: HLA-A*0201positive/HLA-DP4 positive treated with gp100 + MAGE-3 + Leuprolide	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.
4: Experimental Group IIB: HLA-A*0201positive/HLA-DP4 positive treated with gp100 + MAGE-3 - No Leuprolide	Biological: GP100: 209-217(210M) Peptide 1.0 ml subcutaneous injection in extremities. Biological: MAGE-3 Peptide 1.0 ml subcutaneous injection in extremities.

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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%.
WBC >/= 3000/mm^3.
Platelet count >/= 90,000mm^3.
Serum creatinine </= 2.0mg/dl.
Serum ALT </= 3 X upper limit of normal(ULN))
Total bilirubin equal or less than 2X 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 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00254397

Contacts

Contact: Patrick Hwu, MD	713-563-1727	phwu@mdanderson.org
Contact: Priscilla Miller, RN	713-563-9445	pmiller@mdanderson.org

Locations

United States, Texas
U.T.M.D. Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Patrick Hwu, MD

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Patrick Hwu, MD

U.T.M.D. Anderson Cancer Center

More Information

Additional Information:

UT MD Anderson Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Patrick Hwu, MD/Professor )
Study ID Numbers:	2004-0502
Study First Received:	November 14, 2005
Last Updated:	March 9, 2009
ClinicalTrials.gov Identifier:	NCT00254397 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:

Melanoma
Uveal Melanoma
Peptide Vaccine
LHRH-agonist
Leuprolide
Lupron
MAGE-3 Peptide

MAGE-3
GP100 Peptide
Melanoma vaccines
Tumor fighting immune cells
T cells
Skin Cancer
Eye Cancer

Study placed in the following topic categories:

Antineoplastic Agents, Hormonal
Eye Neoplasms
Uveal Melanoma
Adjuvants, Immunologic
Skin Neoplasms
Melanoma
Neuroendocrine Tumors

Neuroectodermal Tumors
Leuprolide
Neoplasms, Germ Cell and Embryonal
Nevus, Pigmented
Intraocular Melanoma
Neuroepithelioma
Nevus

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Reproductive Control Agents
Pharmacologic Actions
Melanoma
Neuroendocrine Tumors

Neuroectodermal Tumors
Neoplasms
Leuprolide
Fertility Agents, Female
Neoplasms, Germ Cell and Embryonal
Therapeutic Uses
Fertility Agents
Nevi and Melanomas

ClinicalTrials.gov processed this record on July 02, 2009