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Biological Therapy in Treating Patients With Metastatic Melanoma

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: NCT00045357
Recruitment Status : Completed
First Posted : July 8, 2003
Last Update Posted : September 21, 2010
National Cancer Institute (NCI)
Information provided by:
Fred Hutchinson Cancer Research Center

Brief Summary:

RATIONALE: Biological therapies use different ways to stimulate the immune system and stop tumor cells from growing. Treating a person's white blood cells in the laboratory and reinfusing them may cause a stronger immune response and kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of biological therapy in treating patients who have metastatic melanoma.

Condition or disease Intervention/treatment Phase
Melanoma (Skin) Biological: therapeutic autologous lymphocytes Phase 1

Detailed Description:



  • Determine the maximum tolerated dose of autologous CD4+ antigen-specific T-cells for cellular adoptive immunotherapy in patients with metastatic melanoma.
  • Determine the safety and toxicity of this regimen in these patients.
  • Determine the duration of in vivo persistence of adoptively transferred CD4+ antigen-specific T-cell clones in these patients.


  • Determine the antitumor effects of this regimen in these patients.

OUTLINE: This is a dose-escalation study.

Patients undergo leukapheresis to collect peripheral blood mononuclear cells. CD4+ antigen-specific T-cell clones are generated over the next 2-3 months using immunogenic peptides MART1, tyrosinase, or gp100.

Patients receive autologous CD4+ antigen-specific T-cells IV over 30 minutes.

Cohorts of 3-6 patients receive escalating doses of autologous CD4+ antigen-specific T-cells until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed on days 1 and 3 post T-cell infusion, and then once weekly for 12 weeks.

PROJECTED ACCRUAL: A total of 3-18 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Primary Purpose: Treatment
Official Title: Phase I Study to Evaluate the Safety of Cellular Adoptive Immunotherapy Using Autologous CD4+ Antigen-Specific T Cell Clones for Patients With Metastatic Melanoma
Study Start Date : November 2001
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed metastatic melanoma
  • HLA type expressing one of the following class II alleles:

    • DRB1*0401
    • DRB1*0404
    • DRB1*1501
    • DPB1*0401
    • DPB1*0402
  • Tumor expresses tyrosinase
  • Tumor expressing NY-ESO-1 and are HLA type DP4, DP2, or DR7 allowed
  • No CNS metastases

    • Prior CNS involvement allowed provided there is no evidence of CNS disease at least 2 months after treatment



  • 18 to 75

Performance status

  • Karnofsky 70-100%

Life expectancy

  • More than 16 weeks


  • WBC greater than 4,000/mm^3
  • Absolute neutrophil count greater than 2,000/mm^3
  • Platelet count greater than 100,000/mm^3
  • Hematocrit greater than 30%


  • SGOT no greater than 3 times upper limit of normal
  • INR no greater than 1.5 due to hepatic dysfunction
  • No significant hepatic dysfunction, defined as hepatic toxicity grade 2 or greater


  • Creatinine no greater than 2.0 mg/dL OR
  • Creatinine clearance at least 60 mL/min
  • Calcium no greater than 12 mg/dL


  • No significant cardiac abnormalities*, defined by any 1 of the following:

    • Congestive heart failure
    • Clinically significant hypotension
    • Symptoms of coronary artery disease
    • Cardiac arrhythmias present on EKG requiring drug therapy NOTE: *Patients with a history of cardiovascular disease or any of the above abnormalities undergo a cardiac evaluation, including a cardiac stress test and/or echocardiogram


  • No clinically significant pulmonary dysfunction
  • FEV1 at least 1.0 L OR
  • FEV1 at least 60%
  • DLCO at least 55% (corrected for hemoglobin)


  • No acquired or hereditary immunodeficiency
  • No autoimmune disease
  • No active infection
  • No oral temperature greater than 38.2 degrees C within the past 72 hours
  • No systemic infection requiring chronic maintenance or suppressive therapy
  • HIV negative


  • No retinitis or choroiditis
  • No history of seizures
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after study


Biologic therapy

  • No other concurrent immunotherapy (e.g., interleukins, interferons, melanoma vaccines, IV immunoglobulin, or expanded polyclonal tumor-infiltrating lymphocytes or lymphokine-activated killer therapy)


  • At least 4 weeks since prior chemotherapy (standard or experimental) and recovered

Endocrine therapy

  • No concurrent systemic steroids except for toxicity management


  • At least 4 weeks since prior radiotherapy


  • Not specified


  • At least 4 weeks since prior immunosuppressive therapy
  • More than 4 weeks since prior experimental drugs and recovered
  • No concurrent pentoxifylline
  • No other concurrent investigational agents

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): NCT00045357

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United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
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Study Chair: Cassian Yee, MD Fred Hutchinson Cancer Research Center
Layout table for additonal information Identifier: NCT00045357    
Other Study ID Numbers: 1585.00
CDR0000256867 ( Registry Identifier: PDQ )
First Posted: July 8, 2003    Key Record Dates
Last Update Posted: September 21, 2010
Last Verified: September 2010
Keywords provided by Fred Hutchinson Cancer Research Center:
recurrent melanoma
stage IV melanoma
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas