MDACC Study Summary 2004-0502

Study Summary
No. 2004-0502:.......Melanoma......Patrick Hwu......Melanoma Medical Oncology

Study Summary Title



Study Summary Number:	2004-0502

Study Title:	Study of the modulatory activity of an LHRH-agonist (Leuprolide) on melanoma peptide vaccines as adjuvant therapy in melanoma patients

Physician

New Patient Referral



Name:	Patrick Hwu	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Melanoma Medical Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-2921 Contact us about clinical trials

General Information



Disease Group:	Melanoma	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:	The patient will come to clinic for RN visit every 3 weeks for 48 weeks to receive injections. Patient will see MD at 3wks, 6wks and then every 6 weeks up to 48 wks if feasible.

Treatment Agents:	GP100: 209-217(210M) Peptide Leuprolide Acetate MAGE-3 peptide	Home Care:	None

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	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.

Study Objectives / Outcomes

Primary objective:

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:

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

Study Status Information



Study Activation / Registration Date:	11/08/2005

IRB Review and Approval Date:	11/17/2004

Study Type:	Therapeutic

Recruitment Status:	Closed

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

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) WBC >/= 3000/mm^3.

6) Platelet count >/= 90,000mm^3.

7) Serum creatinine </= 2.0mg/dl.

8) Serum ALT </= 3 X upper limit of normal(ULN))

9) 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.

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 immunomodulatoy 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 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.

Links

Registration Number: NCT00254397
Study Information on Clinical Trials Registry (clinicaltrials.gov)