Vaccine Therapy in Treating Patients With Refractory Metastatic Melanoma - Full Text View

Sponsor:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00020397

Purpose

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.

Condition	Intervention	Phase
Melanoma (Skin)	Biological: NY-ESO-1 peptide vaccine Biological: aldesleukin	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Immunization Of HLA-A0201 or HLA-DPB104 Patients With Metastatic Melanoma Using Epitopes From The ESO-1 Antigen

Resource links provided by NLM:

MedlinePlus related topics: Cancer Melanoma

Drug Information available for: Aldesleukin

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

November 2000

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.

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00020397

Locations

United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

Study Chair:

Steven A. Rosenberg, MD, PhD

NCI - Surgery Branch

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

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.

Study ID Numbers:	CDR0000068403, NCI-01-C-0032, NCI-2390
Study First Received:	July 11, 2001
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00020397 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

recurrent melanoma
stage IV melanoma

Additional relevant MeSH terms:

Anti-Infective Agents
Neoplasms by Histologic Type
Anti-HIV Agents
Antineoplastic Agents
Neoplasms, Nerve Tissue
Antiviral Agents
Pharmacologic Actions
Melanoma

Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms
Aldesleukin
Anti-Retroviral Agents
Neoplasms, Germ Cell and Embryonal
Therapeutic Uses
Nevi and Melanomas

ClinicalTrials.gov processed this record on November 27, 2009