MDACC Study Summary 2003-0835 (Archived)

Study Summary
No. 2003-0835:.......Melanoma......Patrick Hwu......Melanoma Medical Oncology

Study Summary Title



Study Summary Number:	2003-0835

Study Title:	A PHASE III MULTI-INSTITUTIONAL RANDOMIZED STUDY OF IMMUNIZATION WITH THE gp100: 209-217(210M) PEPTIDE FOLLOWED BY HIGH DOSE IL-2 VS. HIGH DOSE IL-2 ALONE IN PATIENTS WITH METASTATIC MELANOMA

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 III	Return Visit:	Every 3 weeks

Treatment Agents:	GP100: 209-217(210M) Peptide Interleukin-2	Home Care:	For supportive care as needed

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	6-7 days every 3 weeks


Description/ Intervention:	The goal of this clinical research study is to compare high-dose interleukin-2 (IL-2) given alone to IL-2 given in combination with a vaccine called gp100:209-217(210M)] in the treatment of metastatic cutaneous melanoma. Response to treatment, side effects, and the affect of treatment on quality of life will be compared.

Study Objectives / Outcomes

1. Primary objectives:

1.1 In patients with metastatic cutaneous melanoma with HLA-A0201, the primary objective will be to identify whether the addition of the peptide vaccine to high dose IL-2 can result in a clinical response rate which may be superior to that found in similar patients treated with high dose IL-2 alone. Analysis of response will be based on the findings of blinded review of all relevant tumor measurements.

2. Secondary Objectives:

2.1 To evaluate the toxicity profile of patients treated on this trial, according to the regimen received.
2.2 To compare the disease free/progression free survival of patients treated on both arms of the study.
2.3 To determine the immunologic response experienced by patients who have received the peptide vaccination, as measured by changes in T-cell precursors from before to after treatment.
2.4 To evaluate the quality of life of patients before and after high-dose IL-2.

Study Status Information



Study Activation / Registration Date:	12/13/2004

IRB Review and Approval Date:	11/19/2003

Study Type:	Therapeutic

Recruitment Status:	Terminated

Projected Accrual:	185

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) Any patient age 18 yrs or greater with measurable Stage IV or locally advanced Stage III skin melanoma & expected survival > 3 months are eligible.

2) Serum creatinine of 1.6 mg/dl or less, total bilirubin 1.6 mg/dl or less & AST/ALT < 3 X normal

3) WBC 3000/mm3 or greater & platelet count 90,000 mm3 or geater.

4) ECOG performance status < 2.

5) Patients must be willing to practice effective birth control during this trial.

6) Patients with a pathologic diagnosis of skin melanoma are eligible. All slides will be reviewed and diagnosis confirmed at NIH.

7) Tissue type HLA A0201.

Exclusion Criteria:

1) Patients who have non-cutaneous melanoma.

2) Patients who have undergone non-surgical therapy in the past 4 weeks.

3) Patients who have active infections, coagulopathy, autoimmune disease, diabetes mellitus, cardiac disease & inflammatory bowel disorders.

4) Patietns who have psychiatric disease or CNS metastasis.

5) Patients who have used systemic steroids in the past 4 weeks, or topical or inhalational steroids in the past 2 weeks.

6) Patients who are pregnant.

7) Patients who are known to have viral hepatitis B or C or HIV.

8) Patietns who have received high-dose IL-2. or gp100 vaccines.

9) Patients who have an abnormal stress cardiac test, abnormal PFT.

Links

Registration Number: NCT00019682
Study Information on Clinical Trials Registry (clinicaltrials.gov)