Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Vaccine Therapy in Treating Patients With Refractory Metastatic Melanoma

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Completed 16 and over NCI NCI-01-C-0032 NCI-2390, 2390, NCT00020397

Objectives

1. Determine whether an immunologic response can be obtained after administration of ESO-1 peptide vaccine comprising class I , II, or both peptides in HLA-A*201 or HLA-DPB1*04 positive patients with refractory metastatic melanoma expressing ESO-1.
2. Determine the toxicity of this vaccine in these patients.
3. Determine whether prior immunization with this vaccine results in increased clinical responsiveness in patients treated with interleukin-2.

Entry Criteria

Disease Characteristics:

• Diagnosis of metastatic melanoma that expresses ESO-1 antigen



• Must have progressed during prior standard treatment



• Measurable or evaluable disease



• HLA-A*201 or HLA-DPB1*04 positive

Prior/Concurrent Therapy:

Biologic therapy:

• No prior ESO-1 immunization

Chemotherapy:

• Recovered from any prior chemotherapy

Endocrine therapy:

• No concurrent systemic steroid therapy

Radiotherapy:

• Recovered from any prior radiotherapy

Surgery:

• Not specified

Other:

• At least 3 weeks since any prior systemic therapy for cancer
• No other concurrent systemic therapy for cancer

Patient Characteristics:

Age:

• 16 and over

Performance status:

• ECOG 0-2

Life expectancy:

• More than 3 months

Hematopoietic:

• WBC at least 3,000/mm³
• Platelet count at least 90,000/mm³

Hepatic:

• SGOT and SGPT less than 3 times normal
• Bilirubin no greater than 1.6 mg/dL (3.0 mg/dL for patients with Gilbert's syndrome)
• Hepatitis B surface antigen negative

Renal:

• Creatinine no greater than 2.0 mg/dL

Cardiovascular:

• No cardiac ischemia*
• No myocardial infarction*
• No cardiac arrhythmias*

 [Note: *For interleukin-2 (IL-2) administration]

Pulmonary:

• No obstructive or restrictive pulmonary disease (for IL-2 administration)

Immunologic:

• No autoimmune disease
• No active primary or secondary immunodeficiency
• HIV negative
• No active systemic infections

Other:

• Not pregnant
• Negative pregnancy test
• Fertile patients must use effective contraception
• No other active major medical illness (for IL-2 administration)

Expected Enrollment

A total of 45-90 patients (15-30 per treatment group) will be accrued for this study within 1 year.

Outline

Patients are assigned to 1 of 3 groups according to HLA type.

• Group 1 (HLA-A*201 and HLA-DPB1*04 positive): Patients receive ESO-1 peptide vaccine comprising class I (ESO-1:157-165 [165V]) and class II (ESO-1:161-180) peptides subcutaneously once every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.



• Group 2 (HLA-A*201 positive and HLA-DPB1*04 negative):Patients receive ESO-1 peptide vaccine as in group I comprising class I peptide only.



• Group 3 (HLA-A*201 negative and HLA-DPB1*04 positive):Patients receive ESO-1 peptide vaccine as in group I comprising class II peptide only.

Patients who develop disease progression discontinue vaccinations and receive high-dose interleukin (IL-2) IV over 15 minutes every 8 hours for up to 4 days (maximum of 12 doses). Treatment with IL-2 repeats every 10-14 days for 4 courses in the absence of disease progression (after at least 2 courses) or unacceptable toxicity.

Patients who have stable disease or a mixed or partial response to vaccination or IL-2 therapy may be eligible for additional vaccine therapy. Patients who have a complete response to vaccine therapy are eligible for 1 additional treatment.

Patients are followed at 3 weeks.

Khong HT, Yang JC, Topalian SL, et al.: Immunization of HLA-A*0201 and/or HLA-DPbeta1*04 patients with metastatic melanoma using epitopes from the NY-ESO-1 antigen. J Immunother 27 (6): 472-7, 2004 Nov-Dec.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research-Medical Oncology

Steven Rosenberg, MD, PhD, Protocol chair		Ph: 866-820-4505 Email: sar@nih.gov

Registry Information
Official Title		Immunization Of HLA-A*0201 or HLA-DPB1*04 Patients With Metastatic Melanoma Using Epitopes From The ESO-1 Antigen
Trial Start Date		2000-11-09
Registered in ClinicalTrials.gov		NCT00020397
Date Submitted to PDQ		2000-12-01
Information Last Verified		2005-01-28