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

Expanded access is no longer available for this treatment.
Sponsor:
Collaborator:
Information provided by:
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT01005537
First received: October 30, 2009
Last updated: August 4, 2010
Last verified: August 2010
  Purpose

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.


Condition Intervention
Melanoma (Skin)
Biological: aldesleukin
Biological: therapeutic autologous lymphocytes
Drug: cyclophosphamide

Study Type: Expanded Access     What is Expanded Access?
Official Title: Single Patient Study to Evaluate Cellular Adoptive Immunotherapy Using Autologous Lymphocytes Following Cyclophosphamide Conditioning for a Single Patient With Metastatic Melanoma

Resource links provided by NLM:


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

Study Start Date: June 2009
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: aldesleukin
    Given IV and orally
    Biological: therapeutic autologous lymphocytes
    Given IV
    Drug: cyclophosphamide
    Given IV
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01005537

Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Investigators
Principal Investigator: Cassian Yee, MD Fred Hutchinson Cancer Research Center
  More Information

Additional Information:
No publications provided

Responsible Party: Cassian Yee, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT01005537     History of Changes
Other Study ID Numbers: 2355.00, P30CA015704, FHCRC-2355.00, IR-6984, CDR0000648071
Study First Received: October 30, 2009
Last Updated: August 4, 2010
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Cyclophosphamide
Aldesleukin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on April 23, 2014