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Immunization of HLA-0201 Positive Patients With Metastatic Melanoma Using a Peptide From Tyrosinase-related Protein 2 (TRP-2)


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

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Trial Information

Immunization of HLA-0201 Positive Patients With Metastatic Melanoma Using a Peptide From Tyrosinase-related Protein 2 (TRP-2)


OBJECTIVES:

- Determine the clinical responses in patients with HLA-A0201-positive refractory
metastatic melanoma treated with tyrosinase-related protein-2:180-188 peptide vaccine
alone.

- Determine the clinical response rate of patients who have an immediate need to receive
interleukin-2 (IL-2) in addition to this vaccine.

- Compare the immunologic response, in terms of changes in T-cell precursors before and
after treatment, in patients treated with this vaccine with or without IL-2.

- Compare the toxicity profile of these regimens in these patients.

OUTLINE: This is a randomized, open-label study.

Patients who need immediate interleukin-2 (IL-2) receive tyrosinase-related protein-2
(TRP-2):180-188 peptide vaccine emulsified with Montanide ISA-51 on day 1 and high-dose IL-2
IV over 15 minutes once every 8 hours on days 2-5. Treatment repeats every 3 weeks for up to
4 courses in the absence of disease progression or unacceptable toxicity.

Patients who do not need immediate IL-2 are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive TRP-2:180-188 peptide vaccine emulsified with Montanide ISA-51
subcutaneously (SC) on day 1. Treatment repeats every 3 weeks for up to 4 courses in
the absence of disease progression or unacceptable toxicity.

- Arm II: Patients receive TRP-2:180-188 peptide vaccine emulsified with Montanide ISA-51
SC once weekly on weeks 1-4. Treatment repeats every 7 weeks for up to 4 courses in the
absence of disease progression or unacceptable toxicity.

Patients who have a complete response (CR) receive 1 additional course after achieving CR.
Patients who have progressive disease while receiving vaccine alone may cross over to
receive peptide vaccine with IL-2 for at least 2 courses.

Patients are followed at 3 weeks.

PROJECTED ACCRUAL: A maximum of 83 patients (19-33 who need immediate interleukin-2 (IL-2);
15-25 per treatment arm who do not need immediate IL-2) will be accrued for this study
within 1 year.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of metastatic melanoma

- Refractory to standard therapy

- No resectable locoregional disease

- HLA-A0201 positive

- Measurable disease

- Previously resected brain metastases, brain metastases stable after prior
radiosurgery, or brain metastases less than 1 cm and without edema allowed

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

- No coagulation disorders

Hepatic:

- Bilirubin no greater than 2.0 mg/dL (3.0 mg/dL for patients with Gilbert's syndrome)

- AST/ALT less than 3 times normal

- Hepatitis B surface antigen negative

Renal:

- Creatinine no greater than 2.0 mg/dL

Cardiovascular:

- No major medical illness of the cardiovascular system

- No cardiac ischemia*

- No myocardial infarction*

- No cardiac arrhythmias* NOTE: * For interleukin-2 (IL-2) administration

Pulmonary:

- No major medical illness of the respiratory system

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

Immunologic:

- HIV negative

- No primary or secondary immunodeficiency

- No known immunodeficiency disease

- No autoimmune disease

- No active systemic infections

Other:

- Not pregnant

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 3 weeks since prior biologic therapy for melanoma

- No prior immunization to tyrosinase-related protein-2 antigen

- No other concurrent biologic therapy for melanoma

Chemotherapy:

- At least 3 weeks since prior chemotherapy for melanoma and recovered

- No concurrent chemotherapy for melanoma

Endocrine therapy:

- At least 3 weeks since prior endocrine therapy for melanoma

- No concurrent systemic steroid therapy

- No concurrent endocrine therapy for melanoma

Radiotherapy:

- See Disease Characteristics

- At least 3 weeks since prior radiotherapy for melanoma and recovered

- No concurrent radiotherapy for melanoma

Surgery:

- See Disease Characteristics

Other:

- No other concurrent therapy for melanoma

Type of Study:

Interventional

Study Design:

Allocation: Randomized, 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:

CDR0000068818

NCT ID:

NCT00022438

Start Date:

June 2001

Completion Date:

August 2004

Related Keywords:

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

Name

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Studies SupportBethesda, Maryland  20892-1182