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: NCT00045149
Recruitment Status : Completed
First Posted : May 28, 2003
Last Update Posted : May 7, 2010
National Cancer Institute (NCI)
Information provided by:
Fred Hutchinson Cancer Research Center

September 6, 2002
May 28, 2003
May 7, 2010
October 2002
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Complete list of historical versions of study NCT00045149 on Archive Site
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Biological Therapy in Treating Patients With Metastatic Melanoma
Phase I Study to Evaluate the Safety of Cellular Adoptive Immunotherapy Using Autologous CD8+ Antigen Specific T Cell Clones Targeting Cancer Testis Antigens for Patients With Metastatic Melanoma

RATIONALE: Biological therapies such as cellular adoptive immunotherapy use different ways to stimulate the immune system and stop cancer cells from growing. Treating a person's white blood cells in the laboratory and then 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.



  • Determine the safety and toxicity of cellular adoptive immunotherapy comprising autologous CD8+ cytotoxic T-lymphocyte clones targeting cancer-testis antigens in patients with metastatic melanoma.
  • Determine the duration of in vivo persistence of this therapy in these patients.


  • Evaluate the antitumor effects of this therapy in these patients.

OUTLINE: Patients undergo leukapheresis to obtain peripheral blood mononuclear cells and then CD8+ cytotoxic T-lymphocyte (CTL) clones are generated ex vivo. Patients receive cellular adoptive immunotherapy comprising autologous CD8+ CTL clones targeting cancer testis antigens IV over 30 minutes on day 1. Patients also receive interleukin-2 subcutaneously every 12 hours on days 1-14 of courses 2-4. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients who demonstrate a clinical response after completion of the fourth course are eligible to receive additional T-cell infusions.

Patients are followed for 9 months.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study within 3 years.

Phase 1
Masking: None (Open Label)
Primary Purpose: Treatment
Melanoma (Skin)
  • Biological: aldesleukin
  • Biological: therapeutic tumor infiltrating lymphocytes
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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June 2005
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  • Histologically confirmed metastatic melanoma

    • Stage IV disease
  • HLA-A1, -A2, and -A3 positive
  • MAGE-1 or -3 positive by histology
  • Bidimensionally measurable disease by palpation on clinical examination, x-ray, or CT scan
  • No CNS metastases



  • 18 to 75

Performance status

  • Karnofsky 80-100%

Life expectancy

  • More than 6 months


  • Not specified


  • Bilirubin ≤ 1.6 mg/dL
  • SGOT ≤ 3 times upper limit of normal
  • PT ≤ 1.5 times control


  • Creatinine ≤ 2.0 mg/dL
  • Calcium ≤ 12 mg/dL


  • No congestive heart failure
  • No clinically significant hypotension
  • No symptoms of coronary artery disease
  • No cardiac arrhythmias on electrocardiogram requiring drug therapy
  • Patients with prior cardiovascular disease or the presence of any of the above abnormalities undergo a cardiac evaluation, which may include a stress test and/or echocardiogram


  • No clinically significant pulmonary dysfunction by medical history or physical examination
  • FEV_1 ≥ 60% of normal
  • DLCO ≥ 55% (corrected for hemoglobin)


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No retinitis or choroiditis
  • No active infections or oral temperature greater than 38.2 degrees Celsius within the past 72 hours
  • No systemic infection requiring chronic maintenance or suppressive therapy


Biologic therapy

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


  • At least 3 weeks since prior standard or experimental chemotherapy
  • 1-2 courses of prior cytoreductive chemotherapy for bulky disease allowed

Endocrine therapy

  • No concurrent systemic steroids (except for toxicity management)


  • At least 3 weeks since prior radiotherapy


  • Not specified


  • At least 3 weeks since prior immunosuppressive therapy
  • No concurrent pentoxifylline
  • No other concurrent investigational agents
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
CDR0000256451 ( Registry Identifier: PDQ )
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Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Study Chair: Cassian Yee, MD Fred Hutchinson Cancer Research Center
Fred Hutchinson Cancer Research Center
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP