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Vaccine Therapy in Treating Patients With Metastatic Melanoma

This study has been completed.

Sponsors and Collaborators: NCI - Center for Cancer Research-Medical Oncology
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)
Drug: MART-1 antigen
Drug: aldesleukin
Drug: gp100 antigen
Drug: incomplete Freund's adjuvant
Phase II

MedlinePlus related topics:   Cancer    Melanoma   

Drug Information available for:   Aldesleukin    Freund's adjuvant    Montanide ISA 51   

U.S. FDA Resources

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

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
NCI - Center for Cancer Research-Medical Oncology
National Cancer Institute (NCI)

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


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

Publications:

Study ID Numbers:   CDR0000067391, NCI-99-C-0159, NCI-T99-0079
First Received:   July 11, 2001
Last Updated:   October 18, 2008
ClinicalTrials.gov Identifier:   NCT00019994
Health Authority:   United States: Federal Government

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

Study placed in the following topic categories:
Neuroectodermal Tumors
Aldesleukin
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Freund's Adjuvant
Nevus
Recurrence
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:
Anti-Infective Agents
Neoplasms by Histologic Type
Anti-HIV Agents
Immunologic Factors
Antineoplastic Agents
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Adjuvants, Immunologic
Antiviral Agents
Pharmacologic Actions
Neoplasms
Anti-Retroviral Agents
Therapeutic Uses
Nevi and Melanomas

ClinicalTrials.gov processed this record on November 30, 2008




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