Vaccine Therapy in Treating Patients With Refractory Metastatic Melanoma

NCT ID: NCT00020397

Last Updated: 2013-06-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-11-30
• Study Completion Date: 2005-07-31

Brief 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.

Detailed 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.

Conditions

Melanoma (Skin)

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

NY-ESO-1 peptide vaccine

Intervention Type: BIOLOGICAL

aldesleukin

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion 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

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Principal Investigators

Steven A. Rosenberg, MD, PhD

Role: STUDY_CHAIR

NCI - Surgery Branch

Locations

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, United States

Countries

United States

References

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. doi: 10.1097/00002371-200411000-00007.

Reference Type: RESULT

PMID: 15534491 (View on PubMed)

Other Identifiers

NCI-01-C-0032

Identifier Type: -

Identifier Source: secondary_id

NCI-2390

Identifier Type: -

Identifier Source: secondary_id

CDR0000068403

Identifier Type: -

Identifier Source: org_study_id

NCT00006491

Identifier Type: -

Identifier Source: nct_alias