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


Phase 2
16 Years
N/A
Not Enrolling
Both
Melanoma (Skin)

Thank you

Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Steven A. Rosenberg, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

NCI - Surgery Branch

Authority:

United States: Federal Government

Study ID:

CDR0000068403

NCT ID:

NCT00020397

Start Date:

November 2000

Completion Date:

July 2005

Related Keywords:

  • Melanoma (Skin)
  • recurrent melanoma
  • stage IV melanoma
  • Melanoma

Name

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