Immunization of HLA-0201 Positive Patients With Metastatic Melanoma Using a Peptide From Tyrosinase-related Protein 2 (TRP-2)
16 Years
N/A
Both
Melanoma (Skin)
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 Support | Bethesda, Maryland 20892-1182 |
