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Fludarabine Followed by Vaccine Therapy and White Blood Cell Infusions in Treating Patients With Unresectable or 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: NCT00091143
Recruitment Status : Completed
First Posted : September 8, 2004
Last Update Posted : April 4, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as fludarabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Vaccines made from peptides may make the body build an immune response to kill tumor cells. Infusions of a person's white blood cells may be able to replace immune cells that were destroyed by chemotherapy. Combining fludarabine with vaccine therapy and white blood cell infusions may kill more tumor cells.

PURPOSE: This randomized phase I trial is studying the side effects of giving vaccine therapy together with fludarabine and white blood cell infusions and to see how well it works in treating patients with unresectable or metastatic melanoma.

Condition or disease Intervention/treatment Phase
Melanoma (Skin) Biological: gp100 antigen Biological: incomplete Freund's adjuvant Biological: keyhole limpet hemocyanin Drug: fludarabine phosphate Procedure: peripheral blood stem cell transplantation Phase 1

Detailed Description:



  • Determine the toxicity and immune effects of vaccination comprising modified gp100 peptide (gp100:209-217[210M]), Montanide ISA-51, and keyhole limpet hemocyanin followed by peripheral blood mononuclear cell reinfusion after treatment-induced lymphopenia with fludarabine in patients with unresectable or metastatic melanoma.
  • Determine the induction of antigen-specific T-cell responses in patients treated with this regimen.
  • Determine the kinetics and duration of immune response in patients treated with this regimen.
  • Compare the immunologic effects of this regimen in these patients with historical results.


  • Compare 2 different dosing schedules of fludarabine, in terms of induction of lymphopenia and granulocytopenia and on the induction of a specific immune response to this vaccine, in these patients.

OUTLINE: This is a pilot, randomized study. Patients are randomized to 1 of 2 treatment arms.

Within 2 weeks before the start of fludarabine, all patients undergo leukapheresis over 4-6 hours for the collection of peripheral blood mononuclear cells (PBMCs).

  • Arm I: Patients receive fludarabine IV over 30 minutes on days 1-5.
  • Arm II: Patients receive fludarabine as in arm I on days 1, 3, and 5. In both arms, patients receive autologous PBMCs IV over approximately 30 minutes on day 8 and vaccination comprising gp100:209-217(210M) peptide, Montanide ISA-51, and keyhole limpet hemocyanin subcutaneously on days 8, 22, 36, 50, and 64. Patients with stable or responding disease continue to receive vaccination on day 78 and then every 28-31 days for up to 1 year.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 20 patients (10 per treatment arm) will be accrued for this study within 2 years.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Pilot Trial of Therapeutic Vaccination With a Modified gp100 Melanoma Peptide (gp100:209-217(210M)), Montanide ISA 51, and KLH With Reconstitution After Chemotherapy to Induce Lymphopenia in Patients With Metastatic Melanoma
Study Start Date : July 2004
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Primary Outcome Measures :
  1. Toxicity by clinical and laboratory observation at 1 month
  2. Antigen-specific T-cell responses by tetramer analysis, ELISPOT, and cytokine flow cytometry periodically

Secondary Outcome Measures :
  1. Compare 2 different dosing schedules of fludarabine in terms of lymphocyte recovery using a complete blood count periodically
  2. Tumor regression by standard imaging at study completion

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 and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed malignant melanoma

    • Metastatic or unresectable disease
  • Measurable disease
  • HLA-A2 positive
  • Received at least 1 prior immunotherapy and/or chemotherapy regimen for metastatic disease (first 6 patients only)
  • No known brain metastases unless previously treated with radiotherapy and/or surgery AND is stable for at least 1 month after treatment



  • 18 and over

Performance status

  • ECOG 0-2 OR
  • Karnofsky 60-100%

Life expectancy

  • More than 3 months


  • WBC ≥ 3,000/mm^3
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Absolute lymphocyte count ≥ 500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 10 g/dL (transfusions allowed)
  • Hematocrit ≥ 24%
  • No other active bleeding


  • Bilirubin < 2 times upper limit of normal (ULN) (unless due to Gilbert's disease)
  • AST and ALT < 3 times ULN
  • Hepatitis B surface antigen negative
  • Hepatitis C antibody negative


  • Creatinine < 2 mg/dL
  • No uncontrolled hypercalcemia


  • No uncontrolled symptomatic congestive heart failure
  • No unstable angina pectoris
  • No uncontrolled cardiac arrhythmia
  • No uncontrolled hypertension


  • No uncontrolled bronchospasm
  • No hemoptysis


  • Negative serology for all of the following:

    • HIV-1 and HIV-2
    • HTLV-1 and -2
    • Syphilis
  • Rheumatoid factor < 43 units/μL
  • Anti-nuclear antibody < 11 units/μL
  • No history of multiple sclerosis, systemic lupus erythematosus, or myasthenia gravis
  • No primary or secondary immunodeficiency
  • No active infection
  • No allergy to seafood or shellfish that would preclude study participation


  • No active gastrointestinal bleeding
  • No uncontrolled hyperglycemia
  • No other medical or psychiatric condition or social situation that would preclude study compliance
  • No other uncontrolled illness
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3-4 months after study participation


Biologic therapy

  • See Disease Characteristics
  • No prior immunization with gp100:209-217(210M) peptide


  • See Disease Characteristics
  • More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)

Endocrine therapy

  • More than 2 weeks since prior steroid therapy except replacement steroids or inhaled steroids
  • No concurrent corticosteroids except replacement steroids
  • No concurrent dexamethasone


  • See Disease Characteristics
  • More than 2 weeks since prior radiotherapy


  • See Disease Characteristics
  • Recovered from prior surgery


  • No other concurrent investigational agents
  • No other concurrent anticancer therapy

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): NCT00091143

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United States, Oregon
Providence Cancer Center at Providence Portland Medical Center
Portland, Oregon, United States, 97213-2967
Sponsors and Collaborators
Providence Cancer Center, Earle A. Chiles Research Institute
National Cancer Institute (NCI)
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Principal Investigator: Walter J. Urba, MD, PhD Providence Cancer Center, Earle A. Chiles Research Institute
Layout table for additonal information Identifier: NCT00091143    
Other Study ID Numbers: CDR0000383908
First Posted: September 8, 2004    Key Record Dates
Last Update Posted: April 4, 2013
Last Verified: August 2009
Keywords provided by National Cancer Institute (NCI):
recurrent melanoma
stage III 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
Fludarabine phosphate
Freund's Adjuvant
Keyhole-limpet hemocyanin
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic