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Vaccine Therapy in Treating Patients With Metastatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00021164
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 19, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Vaccines made from a peptide may make the body build an immune response and kill tumor cells.

PURPOSE: Randomized phase II trial to study the effectiveness of vaccine therapy in treating patients who have metastatic cancer.

Condition or disease Intervention/treatment Phase
Melanoma (Skin) Unspecified Adult Solid Tumor, Protocol Specific Biological: aldesleukin Biological: incomplete Freund's adjuvant Biological: telomerase: 540-548 peptide vaccine Phase 2

Detailed Description:


  • 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.

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Primary Purpose: Treatment
Official Title: Immunization of HLA-A*0201 Patients With Metastatic Cancer Using a Peptide Epitope From the Telomerase Antigen
Study Start Date : May 2001
Study Completion Date : May 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Presenting with evaluable metastatic cancer

    • Refractory to standard treatment OR
    • Post-radiation for malignant glioma
  • HLA-A*0201 expression



  • 16 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • More than 3 months


  • WBC at least 3,000/mm^3
  • Platelet count at least 90,000/mm^3


  • Bilirubin no greater than 1.6 mg/dL
  • AST/ALT less than 3 times normal
  • Hepatitis B surface antigen negative


  • Creatinine no greater than 2.0 mg/dL


  • No cardiac ischemia by stress thallium or comparable test*
  • No prior myocardial infarction*
  • No cardiac arrhythmias* NOTE: *Patients receiving interleukin-2 (IL-2) only


  • No obstructive or restrictive pulmonary disease (patients receiving IL-2 only)


  • HIV negative
  • No autoimmune disease or any other known immunodeficiency disease
  • No active primary or secondary immunodeficiency


  • 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


Biologic therapy:

  • No prior telomerase: 540-548 peptide immunization


  • Recovered from prior chemotherapy

Endocrine therapy:

  • No requirement for systemic steroid therapy


  • See Disease Characteristics
  • Recovered from prior radiotherapy


  • Not specified


  • At least 3 weeks since prior systemic therapy for cancer

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00021164

United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
Sponsors and Collaborators
National Cancer Institute (NCI)
Study Chair: Steven A. Rosenberg, MD, PhD NCI - Surgery Branch Identifier: NCT00021164     History of Changes
Obsolete Identifiers: NCT00016640
Other Study ID Numbers: CDR0000068756
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: June 19, 2013
Last Verified: April 2004

Keywords provided by National Cancer Institute (NCI):
stage IV melanoma
recurrent melanoma
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Neoplasm Metastasis
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplastic Processes
Pathologic Processes
Freund's Adjuvant
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Adjuvants, Immunologic