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Fludarabine Followed By Adoptive Immunotherapy in Treating Patients With Stage IV 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.
ClinicalTrials.gov Identifier: NCT00317759
Recruitment Status : Completed
First Posted : April 25, 2006
Last Update Posted : October 1, 2015
National Cancer Institute (NCI)
Information provided by:
Fred Hutchinson Cancer Center

Brief Summary:

RATIONALE: Biological therapies such as cellular adoptive immunotherapy use different ways to stimulate the immune system and stop cancer cells from growing. Fludarabine may help the immune system kill more cancer cells.

PURPOSE: Phase I trial to study the effectiveness of fludarabine followed by cellular adoptive immunotherapy in treating patients who have metastatic melanoma.

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

Detailed Description:



  • Determine the safety and toxicity of adoptive immunotherapy comprising autologous CD8+ antigen-specific cytotoxic T-lymphocyte (CTL) clones after fludarabine in patients with stage IV melanoma.
  • Determine the duration of in vivo persistence of these CTL clones in these patients.


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

OUTLINE: This is an open-label, nonrandomized study.

Patients undergo leukapheresis or weekly phlebotomy for the collection of peripheral blood mononuclear cells from which autologous antigen-specific CD8+ cytotoxic T-lymphocyte (CTL) clones are generated. Patients receive autologous antigen-specific CD8+ CTL clones IV over 30-60 minutes on days 0 and 21 in the absence of rapid disease progression or unacceptable toxicity. Patients also receive fludarabine IV once daily on days 14-18.

Patients are followed for up to 1 year.

PROJECTED ACCRUAL: A total of 12 patients will be accrued for this study within 3 years.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study to Evaluate the Safety of Cellular Adoptive Immunotherapy Using Autologous CD8+ Antigen-Specific T Cell Clones Following Fludarabine Lymphodepletion for Patients With Metastatic Melanoma
Study Start Date : May 2003
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Information from the National Library of Medicine

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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

    • Stage IV disease
  • HLA-A2 or -A3-expressing disease
  • Bidimensionally measurable residual disease by palpation or radiographic imaging (e.g., x-ray or CT scan)
  • No CNS metastases

    • Previously treated CNS involvement allowed provided there is no evidence of CNS disease at least 2 months after completion of therapy



  • 18 to 75

Performance status

  • Karnofsky 80-100%

Life expectancy

  • More than 6 months


  • Platelet count > 100,000/mm^3
  • Absolute neutrophil count > 2,000/mm^3


  • SGOT no greater than 3 times upper limit of normal
  • Bilirubin no greater than 1.6 mg/dL
  • INR no greater than 1.5 times normal


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


  • No congestive heart failure
  • No clinically significant hypotension
  • No symptoms of coronary artery disease
  • No cardiac arrhythmia by EKG requiring drug therapy


  • No clinically significant pulmonary dysfunction
  • FEV_1 at least 1.0 L*
  • DLCO at least 45%* NOTE: *For patients with a history of pulmonary dysfunction


  • No active infection
  • No oral temperature greater than 38.2°C within the past 48 hours
  • No systemic infection requiring chronic maintenance or suppressive therapy


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception


Biologic therapy

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


  • At least 3 weeks since prior chemotherapy (standard or experimental)

Endocrine therapy

  • No concurrent steroids


  • 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

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 ClinicalTrials.gov identifier (NCT number): NCT00317759

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United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024
Sponsors and Collaborators
Fred Hutchinson Cancer Center
National Cancer Institute (NCI)
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Principal Investigator: Cassian Yee, MD Fred Hutchinson Cancer Center
Publications of Results:
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ClinicalTrials.gov Identifier: NCT00317759    
Other Study ID Numbers: 1796.00
CDR0000327817 ( Registry Identifier: PDQ )
First Posted: April 25, 2006    Key Record Dates
Last Update Posted: October 1, 2015
Last Verified: May 2010
Keywords provided by Fred Hutchinson Cancer Center:
stage IV melanoma
recurrent 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
Fludarabine phosphate
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs