Melanoma Vaccine With Peptides and Leuprolide

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00254397
First received: November 14, 2005
Last updated: February 12, 2013
Last verified: February 2013
  Purpose

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.

Condition Intervention Phase
Melanoma
Drug: Leuprolide
Biological: GP100: 209-217(210M) Peptide
Biological: MAGE-3 Peptide
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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:


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

Primary Outcome Measures:
  • T-cell responses to peptide vaccine [ Time Frame: Up to 48 weeks following vaccine ] [ Designated as safety issue: No ]
    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. T-cell response will be measured approximately at baseline, 6, 12, and then every 12 weeks, up to 48 weeks following initial vaccine.


Enrollment: 98
Study Start Date: November 2005
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: gp100 + Leuprolide
Group IA: HLA-A*0201 positive/HLA-DP4 negative treated with gp100 (1.0 ml subcutaneous injection in extremities) + Leuprolide (3-month 11.25 mg sustained-release formulation administrated intramuscularly then again 12 weeks later (2 injections)).
Drug: Leuprolide
A 3-month 11.25 mg sustained-release formulation will be administrated intramuscularly at time 0, and approximately 12 weeks (2 injections).
Other Names:
  • Lupron Depot
  • Lupron
Biological: GP100: 209-217(210M) Peptide
1.0 ml subcutaneous injection in extremities.
Experimental: gp100 - No Leuprolide
Group IB: HLA-A*0201 positive/HLA-DP4 negative treated with gp100 (1.0 ml subcutaneous injection in extremities) - No Leuprolide
Biological: GP100: 209-217(210M) Peptide
1.0 ml subcutaneous injection in extremities.
Experimental: gp100 + MAGE-3 + Leuprolide
Group IIA: HLA-A*0201positive/HLA-DP4 positive treated with gp100 (1.0 ml subcutaneous injection in extremities) + MAGE-3 (1.0 ml subcutaneous injection in extremities) + Leuprolide (3-month 11.25 mg sustained-release formulation administrated intramuscularly then again 12 weeks later (2 injections)).
Drug: Leuprolide
A 3-month 11.25 mg sustained-release formulation will be administrated intramuscularly at time 0, and approximately 12 weeks (2 injections).
Other Names:
  • Lupron Depot
  • Lupron
Biological: GP100: 209-217(210M) Peptide
1.0 ml subcutaneous injection in extremities.
Biological: MAGE-3 Peptide
1.0 ml subcutaneous injection in extremities.
Other Name: MAGE-3
Experimental: gp100 + MAGE-3 - No Leuprolide
Group IIB: HLA-A*0201positive/HLA-DP4 positive treated with gp100 (1.0 ml subcutaneous injection in extremities) + MAGE-3 (1.0 ml subcutaneous injection in extremities) - 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.
Other Name: MAGE-3

  Show Detailed Description

  Eligibility

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

Inclusion Criteria:

  1. HLA-A *0201 positive
  2. Patients >/= 18 years old with histologically documented diagnosis of stage IIb-IV melanomas and are clinically rendered free of disease after surgery
  3. Uveal melanoma patients following definitive treatment of radiation therapy and/or enucleation.
  4. Karnofsky Performance Scale >/= 60%.
  5. White Blood Count (WBC) >/= 3000/mm^3.
  6. Platelet count >/= 90,000mm^3.
  7. Serum creatinine </= 2.0mg/dl.
  8. Serum alanine aminotransferase (ALT) </= 3 times upper limit of normal(ULN))
  9. Total bilirubin equal or less than 2 times upper limit of normal (ULN)), except for patient with Gilbert's syndrome who must have a total bilirubin less than 3.0mg/dl.
  10. 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.)
  11. Negative pregnancy test by serum or urine b-HCG test for women who have menstruation in the past 12 months and without sterilization surgery.
  12. 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:

  1. Prior systemic therapy (including immunomodulate agents), radiation or surgery requiring general anesthesia for melanoma within 28 days of starting study treatment.
  2. Autoimmune diseases.
  3. Concurrent systemic or inhaled steroid therapy.
  4. Any form of active primary or secondary immunodeficiency.
  5. History of immunization with gp100 or MAGE-3.
  6. 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.
  7. Received a Luteinizing hormone-releasing hormone (LHRH) agonist within the past 5 years.
  8. Use of oral contraceptive, hormone replacement therapy or androgen preparations.
  9. Hypersensitivity to gonadotropin-releasing hormone analogues.
  10. Active systemic infections requiring intravenous antibiotics.
  11. Lactating women or women planning lactation during the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Patrick Hwu, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00254397     History of Changes
Other Study ID Numbers: 2004-0502
Study First Received: November 14, 2005
Last Updated: February 12, 2013
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

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Leuprolide
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 16, 2014