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Vaccine Therapy in Treating Patients With Metastatic Cancer
This study has been completed.
First Received: July 11, 2001   Last Updated: February 6, 2009   History of Changes
Sponsor: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00021164
  Purpose

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 Intervention Phase
Melanoma (Skin)
Unspecified Adult Solid Tumor, Protocol Specific
 Biological: aldesleukin
Biological: incomplete Freund's adjuvant
Biological: telomerase: 540-548 peptide vaccine
 Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
Official Title: Immunization of HLA-A*0201 Patients With Metastatic Cancer Using a Peptide Epitope From the Telomerase Antigen

Resource links provided by NLM:

MedlinePlus related topics: Cancer Melanoma
Drug Information available for: Aldesleukin Freund's adjuvant
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: May 2001
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00021164

Locations
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)
Investigators
Study Chair: Steven A. Rosenberg, MD, PhD NCI - Surgery Branch
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers: CDR0000068756, NCI-01-C-0176, NCI-4970
Study First Received: July 11, 2001
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00021164     History of Changes
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on November 27, 2009



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