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Fludarabine Followed By Adoptive Immunotherapy in Treating Patients With Stage IV Melanoma

This study has been completed.
National Cancer Institute (NCI)
Information provided by:
Fred Hutchinson Cancer Research Center Identifier:
First received: April 24, 2006
Last updated: September 30, 2015
Last verified: May 2010

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 Intervention Phase
Melanoma (Skin)
Biological: therapeutic autologous lymphocytes
Drug: fludarabine phosphate
Phase 1

Study Type: Interventional
Study Design: Masking: 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

Resource links provided by NLM:

Further study details as provided by Fred Hutchinson Cancer Research Center:

Estimated Enrollment: 12
Study Start Date: May 2003
Study Completion Date: October 2008
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.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00317759

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)
Principal Investigator: Cassian Yee, MD Fred Hutchinson Cancer Research Center
  More Information

Publications: Identifier: NCT00317759     History of Changes
Other Study ID Numbers: 1796.00  FHCRC-1796.00  CDR0000327817 
Study First Received: April 24, 2006
Last Updated: September 30, 2015
Health Authority: United States: Federal Government

Keywords provided by Fred Hutchinson Cancer Research Center:
stage IV melanoma
recurrent melanoma

Additional relevant MeSH terms:
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
Antiviral Agents
Anti-Infective Agents processed this record on October 26, 2016