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Cyclophosphamide, Cellular Adoptive Immunotherapy, and Aldesleukin in Treating Patients With Metastatic Melanoma
This study is ongoing, but not recruiting participants.
Study NCT00438984   Information provided by National Cancer Institute (NCI)
First Received: February 20, 2007   Last Updated: February 6, 2009   History of Changes

February 20, 2007
February 6, 2009
November 2006
April 2009   (final data collection date for primary outcome measure)
  • Safety [ Designated as safety issue: Yes ]
  • Duration of in vivo persistence of adoptively transferred CD8+ cytotoxic T-lymphocyte clones [ Designated as safety issue: Yes ]
  • Safety
  • Duration of in vivo persistence of adoptively transferred cytotoxic T-lymphocyte clones
Complete list of historical versions of study NCT00438984 on ClinicalTrials.gov Archive Site
Response [ Designated as safety issue: No ]
Response
 
Cyclophosphamide, Cellular Adoptive Immunotherapy, and Aldesleukin in Treating Patients With Metastatic Melanoma
Phase I Study To Evaluate Cellular Adoptive Immunotherapy Using Autologous CD8+ Antigen-Specific T Cell Clones Following Cyclophosphamide Conditioning For Patients With Metastatic Melanoma

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 therapies, such as cellular adoptive immunotherapy, may stimulate the immune system in different ways and stop tumor cells from growing. Aldesleukin may stimulate white blood cells to kill tumor cells. Giving cyclophosphamide together with cellular adoptive immunotherapy and aldesleukin may be an effective treatment for metastatic melanoma.

PURPOSE: This phase I trial is studying the side effects of cyclophosphamide, cellular adoptive immunotherapy, and aldesleukin in treating patients with metastatic melanoma.

OBJECTIVES:

Primary

  • Assess the safety and toxicity of cyclophosphamide, adoptive immunotherapy comprising autologous CD8+ antigen-specific cytotoxic T-lymphocyte (CTL) clones, and aldesleukin in patients with metastatic melanoma.
  • Assess the duration of in vivo persistence of adoptively transferred CD8+ CTL clones.

Secondary

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

OUTLINE: This is a nonrandomized study. Patients undergo leukapheresis or blood draws for collection of peripheral blood mononuclear cells for the generation of antigen-specific cytotoxic T-lymphocyte (CTL) clones. Patients are assigned to 1 of 2 treatment cohorts.

  • Cohort I: Patients receive cyclophosphamide IV on days -3 and -2 and autologous CD8+ CTL clones IV over 30-60 minutes on day 0. Patients also receive high-dose aldesleukin subcutaneously (SC) 3 times a day on days 0-5 in the absence of disease progression or unacceptable toxicity.
  • Cohort II: Patients receive cyclophosphamide and autologous CD8+ CTL clones as in cohort I. Patients receive low-dose aldesleukin SC twice daily on days 0-14 in the absence of disease progression or unacceptable toxicity.

After the completion of study treatment, patients are followed periodically for at least 1 year.

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

Phase I
Interventional
Treatment, Non-Randomized
Melanoma (Skin)
  • Biological: aldesleukin
  • Biological: therapeutic autologous lymphocytes
  • Drug: cyclophosphamide
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
12
 
April 2009   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically confirmed metastatic melanoma

    • Progressive disease after conventional therapy
  • HLA-A2, B44, Cw7, or A24 positive disease
  • Bidimensionally measurable disease
  • No current CNS metastases

    • Previously treated CNS metastases may be allowed provided there is no recurrence within the past 2 months

PATIENT CHARACTERISTICS:

  • Zubrod performance status 0
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Creatinine ≤ 1.6 mg/dL OR creatinine clearance ≥ 75 mL/min
  • AST ≤ 3 times upper limit of normal
  • Bilirubin ≤ 1.6 mg/dL
  • PTT ≤ 1.5 times control
  • Able to tolerate high-dose cyclophoshamide (cohorts I and II) and high-dose aldesleukin (cohort I)
  • Must meet the following criteria to undergo leukapheresis:

    • Pulse > 40 or < 120
    • Weight ≥ 45 kg
    • Temperature ≤ 100.4 F°
    • WBC ≥ 3,000/mm³
    • Hematocrit ≥ 30%
    • Platelet count ≥ 100,000/mm³
  • No clinically significant pulmonary dysfunction, including any of the following:

    • FEV_1 < 2.0 L
    • DLCO < 75%
  • No significant cardiovascular abnormalities, including any 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% by echocardiogram or MUGA
  • No active infections or oral temperature > 38.2°C within the past 72 hours
  • No systemic infection requiring chronic maintenance or suppressive therapy
  • No clinically significant autoimmune disorders or conditions of immunosuppression
  • No AIDS, HIV-1-associated complex, or known HIV antibody seropositivity
  • No recent hepatitis positivity by polymerase chain reaction
  • Normal cardiac stress within the past 182 days required for patients with any of the following:

    • Over 50 years old
    • Abnormal EKG
    • Personal or family history of cardiac disease
    • Hypercholesterolemia
    • Hypertension

PRIOR CONCURRENT THERAPY:

  • At least 24 hours since prior and no concurrent antihypertensive medications during aldesleukin therapy
  • At least 3 weeks since prior chemotherapy, radiotherapy, or immunosuppressive therapy
  • At least 3 weeks since prior experimental drugs and recovered
  • No concurrent systemic steroids
  • No other concurrent immunotherapy, including any of the following:

    • Interleukin
    • Interferon
    • Melanoma vaccines
    • Intravenous immunoglobulin
    • Expanded polyclonal tumor-infiltrating lymphocytes or lymphokine-activated killer cell therapy
  • No concurrent pentoxifylline
  • No other concurrent investigational agents
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00438984
 
CDR0000531135, FHCRC-2140.00
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Principal Investigator: Cassian Yee, MD Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP