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Cyclophosphamide, Autologous Lymphocytes, and Aldesleukin in Treating Patients With Metastatic Melanoma

Primary Purpose

Melanoma (Skin)

Status
No longer available
Phase
Locations
Study Type
Expanded Access
Intervention
aldesleukin
therapeutic autologous lymphocytes
cyclophosphamide
Sponsored by
Fred Hutchinson Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Melanoma (Skin) focused on measuring stage IV melanoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

  • Histopathological documentation of melanoma concurrent with the diagnosis of metastatic disease.
  • 18 to 75 years of age and able to tolerate high-dose cyclophosphamide
  • Bi-dimensionally measurable disease by palpation on clinical exam, or radiographic imaging (X-ray, CT scan).
  • For patients receiving HD-IL-2, normal cardiac stress test within 182 days prior to enrollment is required of all patients over 50 years old or those with an abnormal ECG, any history of cardiac disease, a family history of cardiac disease, hypercholesterolemia or hypertension.

  • For leukapheresis, patients must meet the following criteria (any exceptions to this will require prior approval by the Apheresis director and Principal Investigator):

    • Pulse: >45 or < 120
    • Weight: >45 kg
    • Temperature: <38C (<100.4 F)
    • WBC: >3,000
    • HCT: >30%
    • Platelets: >100,000
  • ADDITIONAL INCLUSION CRITERIA FOR T CELL INFUSION

Exclusion Criteria

  • Significant cardiovascular abnormalities as defined by any one of the following:

    • congestive heart failure,
    • clinically significant hypotension,
    • symptoms of coronary artery disease,
    • presence of cardiac arrhythmias on EKG requiring drug therapy
    • ejection fraction < 50 % (echocardiogram or MUGA)
  • Patients with active infections or oral temperature > 38.2 C within 72 hours of study entry or systemic infection requiring chronic maintenance or suppressive therapy.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    October 30, 2009
    Last Updated
    August 4, 2010
    Sponsor
    Fred Hutchinson Cancer Center
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01005537
    Brief Title
    Cyclophosphamide, Autologous Lymphocytes, and Aldesleukin in Treating Patients With Metastatic Melanoma
    Official Title
    Single Patient Study to Evaluate Cellular Adoptive Immunotherapy Using Autologous Lymphocytes Following Cyclophosphamide Conditioning for a Single Patient With Metastatic Melanoma
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    August 2010
    Overall Recruitment Status
    No longer available
    Study Start Date
    June 2009 (undefined)
    Primary Completion Date
    October 2010 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Fred Hutchinson Cancer Center
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    5. Study Description

    Brief Summary
    RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Biological therapy, such as cellular adoptive immunotherapy using autologous lymphocytes, may stimulate the immune system in different ways and stop tumor cells from growing. Aldesleukin may stimulate the lymphocytes to kill tumor cells. Giving cyclophosphamide together with autologous lymphocytes and aldesleukin may be an effective treatment for metastatic melanoma. PURPOSE: This phase I/II trial is studying the side effects of giving cyclophosphamide together with autologous lymphocytes and aldesleukin and to see how well it works in treating patients with metastatic melanoma.
    Detailed Description
    OBJECTIVES: Primary Assess the safety and toxicity of cellular adoptive immunotherapy with autologous tumor-infiltrating lymphocytes (TIL) following cyclophosphamide conditioning and post-infusion aldesleukin (IL-2) in patients with metastatic melanoma. Assess the duration of in vivo persistence of adoptively transferred lymphocytes. Secondary Evaluate the antitumor effect of adoptively transferred autologous TIL following cyclophosphamide conditioning and post-infusion IL-2 in these patients. OUTLINE: Patients receive cyclophosphamide IV on days -3 and -2 and autologous tumor-infiltrating lymphocytes (TIL) IV on day 0. Beginning 6 hours after TIL infusion, patients receive high-dose aldesleukin (IL-2) IV three times daily on days 0-5 (for up to 14 doses) OR low-dose IL-2 subcutaneously twice daily on days 0-14 (for up to 28 doses). Patients may then receive two additional courses of TILs and low-dose IL-2 (with or without cyclophosphamide), if indicated. After completion of study treatment, patients are followed up periodically.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Melanoma (Skin)
    Keywords
    stage IV melanoma

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Biological
    Intervention Name(s)
    aldesleukin
    Intervention Description
    Given IV and orally
    Intervention Type
    Biological
    Intervention Name(s)
    therapeutic autologous lymphocytes
    Intervention Description
    Given IV
    Intervention Type
    Drug
    Intervention Name(s)
    cyclophosphamide
    Intervention Description
    Given IV

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria Histopathological documentation of melanoma concurrent with the diagnosis of metastatic disease. 18 to 75 years of age and able to tolerate high-dose cyclophosphamide Bi-dimensionally measurable disease by palpation on clinical exam, or radiographic imaging (X-ray, CT scan). For patients receiving HD-IL-2, normal cardiac stress test within 182 days prior to enrollment is required of all patients over 50 years old or those with an abnormal ECG, any history of cardiac disease, a family history of cardiac disease, hypercholesterolemia or hypertension. For leukapheresis, patients must meet the following criteria (any exceptions to this will require prior approval by the Apheresis director and Principal Investigator): Pulse: >45 or < 120 Weight: >45 kg Temperature: <38C (<100.4 F) WBC: >3,000 HCT: >30% Platelets: >100,000 ADDITIONAL INCLUSION CRITERIA FOR T CELL INFUSION Exclusion Criteria Significant cardiovascular abnormalities as defined by any one of the following: congestive heart failure, clinically significant hypotension, symptoms of coronary artery disease, presence of cardiac arrhythmias on EKG requiring drug therapy ejection fraction < 50 % (echocardiogram or MUGA) Patients with active infections or oral temperature > 38.2 C within 72 hours of study entry or systemic infection requiring chronic maintenance or suppressive therapy.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Cassian Yee, MD
    Organizational Affiliation
    Fred Hutchinson Cancer Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Cyclophosphamide, Autologous Lymphocytes, and Aldesleukin in Treating Patients With Metastatic Melanoma

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