Immunization of HLA-A*0201 Patients With Metastatic Cancer Using a Peptide Epitope From the Telomerase Antigen
16 Years
N/A
Both
Melanoma (Skin), Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
Immunization of HLA-A*0201 Patients With Metastatic Cancer Using a Peptide Epitope From the Telomerase Antigen
OBJECTIVES:
- Determine whether an immunologic response can be obtained in HLA*0201-expressing
patients with metastatic cancer treated with telomerase: 540-548 peptide vaccine
emulsified in Montanide ISA-51.
- Determine which vaccine strategy (frequency, schedule, and dosing) is best for future
studies in these patients.
- Determine the toxicity of this treatment in these patients.
- Determine whether prior immunization with telomerase: 540-548 peptide vaccine results
in increased clinical response to interleukin-2 in patients with melanoma.
OUTLINE: This is a randomized study. Patients are stratified according to disease
(metastatic cutaneous melanoma vs other tumor types). Patients are randomized to one of
three treatment arms.
- Arm I: Patients receive telomerase: 540-548 peptide vaccine emulsified in Montanide
ISA-51 subcutaneously (SC) on day 1 of weeks 1-4 and 7-10. Patients also undergo
leukapheresis over 3 hours at baseline and after each course of treatment.
- Arm II: Patients receive telomerase: 540-548 peptide vaccine emulsified in Montanide
ISA-51 SC on day 1 of weeks 1, 4, 7, and 10. Patients also undergo leukapheresis over 3
hours at baseline, after the vaccine on week 4, and after each course of treatment.
- Arm III: Patients receive telomerase: 540-548 peptide vaccine emulsified in Montanide
ISA-51 SC on days 1-4 of weeks 1, 4, 7, and 10. Patients undergo leukapheresis as in
arm II.
Treatment in all arms repeats every 13 weeks for 4-6 courses in the absence of disease
progression or unacceptable toxicity. Patients with a complete response (CR) receive 1
additional course of treatment after achieving CR.
Eligible melanoma patients with progressive disease on vaccine alone on any of the 3 arms
may receive interleukin-2 (IL-2) combined with vaccine as in arm II. Beginning the day after
each immunization, IL-2 is administered IV over 15 minutes every 8 hours over 4 days on
weeks 1, 4, 7, and 10 for a maximum of 12 doses. Patients continuing to experience disease
progression on combined vaccine and IL-2 therapy go off study after 2 courses of combined
therapy.
Patients are followed at 3 weeks.
PROJECTED ACCRUAL: A total of 90-162 patients (30-54 per treatment arm; 45-81 per stratum)
will be accrued for this study within less than 2 years.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Presenting with evaluable metastatic cancer
- Refractory to standard treatment OR
- Post-radiation for malignant glioma
- HLA-A*0201 expression
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:
- Bilirubin no greater than 1.6 mg/dL
- AST/ALT less than 3 times normal
- Hepatitis B surface antigen negative
Renal:
- Creatinine no greater than 2.0 mg/dL
Cardiovascular:
- No cardiac ischemia by stress thallium or comparable test*
- No prior myocardial infarction*
- No cardiac arrhythmias* NOTE: *Patients receiving interleukin-2 (IL-2) only
Pulmonary:
- No obstructive or restrictive pulmonary disease (patients receiving IL-2 only)
Immunologic:
- HIV negative
- No autoimmune disease or any other known immunodeficiency disease
- No active primary or secondary immunodeficiency
Other:
- No other active major medical illness*
- No active systemic infection
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception NOTE: *Patients receiving IL-2 only
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior telomerase: 540-548 peptide immunization
Chemotherapy:
- Recovered from prior chemotherapy
Endocrine therapy:
- No requirement for systemic steroid therapy
Radiotherapy:
- See Disease Characteristics
- Recovered from prior radiotherapy
Surgery:
- Not specified
Other:
- At least 3 weeks since prior systemic therapy for cancer
Type of Study:
Interventional
Study Design:
Allocation: Randomized, 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:
CDR0000068756
NCT ID:
NCT00021164
Start Date:
May 2001
Completion Date:
May 2004
Related Keywords:
- Melanoma (Skin)
- Unspecified Adult Solid Tumor, Protocol Specific
- stage IV melanoma
- recurrent melanoma
- unspecified adult solid tumor, protocol specific
- Melanoma
- Neoplasm Metastasis
Name | Location |
|---|---|
| Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | Bethesda, Maryland 20892-1182 |
