Vaccine Therapy in Treating Patients With Refractory Metastatic Melanoma

Melanoma (Skin) Clinical Trial

Official title:

Immunization Of HLA-A*0201 or HLA-DPB1*04 Patients With Metastatic Melanoma Using Epitopes From The ESO-1 Antigen

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00020397
• Other study ID #: CDR0000068403
• Secondary ID: NCI-01-C-0032NCI
• Status: Completed
• Phase: Phase 2
• First received: July 11, 2001
• Last updated: June 18, 2013
• Start date: November 2000
• Est. completion date: July 2005

Study information

• Verified date: January 2005
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.

PURPOSE: Randomized phase II trial to study the effectiveness of vaccine therapy in treating patients who have refractory metastatic melanoma.

Description:

OBJECTIVES:

• 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.

• Determine the toxicity of this vaccine in these patients.

• Determine whether prior immunization with this vaccine results in increased clinical responsiveness in patients treated with interleukin-2.

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.

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

Other known NCT identifiers

• NCT00006491

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

PATIENT CHARACTERISTICS:

Age:

• 16 and over

Performance status:

• ECOG 0-2

Life expectancy:

• More than 3 months

Hematopoietic:

• WBC at least 3,000/mm^3

• Platelet count at least 90,000/mm^3

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)

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma
• Melanoma (Skin)

Intervention

Biological:
• NY-ESO-1 peptide vaccine

• aldesleukin

Locations

Country	Name	City	State
United States	Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Khong HT, Yang JC, Topalian SL, Sherry RM, Mavroukakis SA, White DE, Rosenberg SA. Immunization of HLA-A*0201 and/or HLA-DPbeta1*04 patients with metastatic melanoma using epitopes from the NY-ESO-1 antigen. J Immunother. 2004 Nov-Dec;27(6):472-7. — View Citation