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Immunization of HLA-A*0201 Patients With Metastatic Cancer Using a Peptide Epitope From the Telomerase Antigen


Phase 2
16 Years
N/A
Not Enrolling
Both
Melanoma (Skin), Unspecified Adult Solid Tumor, Protocol Specific

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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 SupportBethesda, Maryland  20892-1182