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Vaccine Therapy in Treating Patients With Metastatic Melanoma
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: NCT00019994
  Purpose

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.

PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients who have metastatic melanoma that has not responded to previous therapy.


Condition Intervention Phase
Melanoma (Skin)
 Biological: MART-1 antigen
Biological: aldesleukin
Biological: gp100 antigen
Biological: incomplete Freund's adjuvant
 Phase II

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Immunization of Patients With Metastatic Melanoma Using a Class II Restricted Peptide From the GP100 Antigen and Class I Restricted Peptides From the GP100 and MART-1 Antigens

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: October 1999
Detailed Description:

OBJECTIVES:

  • Determine the clinical response to immunization using gp100:44-59 antigen peptide plus gp100:209-217 (210M) and MART-1:26-35 (27L) antigen peptides in patients with metastatic melanoma who are HLA-DRB1*0401 and HLA-A0201 positive.
  • Determine the clinical response to immunization using gp100:44-59 antigen peptide alone in patients with metastatic melanoma who are HLA-DRB1*0401 positive but HLA-A0201 negative.
  • Determine the immunologic response in patients treated with these regimens as measured by changes in T-cell precursors from before to after treatment.
  • Evaluate the toxicity profiles of these regimens in these patients.

OUTLINE: Patients are assigned to one of three immunization groups based on HLA-A0201 status and prior gp100:209-217 (210M) antigen peptide immunization:

  • Group 1 (HLA-A0201 positive and no prior gp100:209-217 [210M] antigen peptide): Patients receive gp100:44-59 and gp100:209-217 (210M) antigen peptides emulsified together in Montanide ISA-51 (ISA-51) subcutaneously (SC) and gp100:44-59 and MART-1:26-35 (27L) antigen peptides emulsified together in ISA-51 SC.
  • Group 2 (HLA-A0201 positive and prior gp100:209-217 [210M] antigen peptide): Patients receive treatment as in group 1.
  • Group 3 (HLA-A0201 negative and no prior gp100:209-217 [210M] antigen peptide): Patients receive gp100:44-59 antigen peptide emulsified in ISA-51 SC alone.
  • All groups: Treatment repeats every 3 weeks for 4 doses in the absence of disease progression or unacceptable toxicity. Patients with complete response after 4 doses receive a maximum of 2 additional doses. Patients with stable disease or minor, mixed, or partial response after 4 doses receive a maximum of 12 additional doses. Patients with no response after 4 doses receive immunization with the same peptides and interleukin-2 IV over 15 minutes every 8 hours for a maximum of 12 doses beginning 1 day after each immunization.

Patients are followed at 3-4 weeks.

PROJECTED ACCRUAL: A total of 45-75 patients (15-25 per immunization group) will be accrued for this study within 2 years.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically proven metastatic melanoma that has failed standard treatment
  • HLA-DRB1*0401 positive
  • Known HLA-A0201 status

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 2.0 mg/dL
  • AST or ALT less than 3 times normal
  • Hepatitis B surface antigen negative

Renal:

  • Creatinine no greater than 2.0 mg/dL

Cardiovascular:

  • No symptomatic cardiac disease

Immunologic:

  • No autoimmune disease
  • No primary or secondary immunodeficiency disease
  • HIV negative

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No active systemic infection

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior immunization to the entire gp100 molecule
  • At least 3 weeks since prior gp100:209-217 antigen peptide
  • At least 3 weeks since other prior biologic therapy

Chemotherapy:

  • At least 3 weeks since prior chemotherapy

Endocrine therapy:

  • At least 3 weeks since prior endocrine therapy
  • No concurrent steroid therapy

Radiotherapy:

  • At least 3 weeks since prior radiotherapy

Surgery:

  • Prior surgery for cancer allowed

Other:

  • At least 3 weeks since any prior therapy except surgery for cancer
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00019994

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

Publications:
Phan GQ, Touloukian CE, Yang JC, Restifo NP, Sherry RM, Hwu P, Topalian SL, Schwartzentruber DJ, Seipp CA, Freezer LJ, Morton KE, Mavroukakis SA, White DE, Rosenberg SA. Immunization of patients with metastatic melanoma using both class I- and class II-restricted peptides from melanoma-associated antigens. J Immunother. 2003 Jul-Aug;26(4):349-56.

Study ID Numbers: CDR0000067391, NCI-99-C-0159, NCI-T99-0079
Study First Received: July 11, 2001
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00019994     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV melanoma
recurrent melanoma

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

ClinicalTrials.gov processed this record on November 27, 2009



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