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

Stopped early · Phase 1

Conditions studied: Stage IV Melanoma

In brief

RATIONALE: Aldesleukin may stimulate lymphocytes to kill melanoma cells. Treating lymphocytes with interleukin-21 in the laboratory may help the lymphocytes kill more tumor cells when they are put back in the body. Giving therapeutic autologous lymphocytes together with cyclophosphamide and aldesleukin may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of giving therapeutic autologous lymphocytes together with cyclophosphamide and aldesleukin in treating patients with metastatic melanoma

Key facts

Study ID: NCT01106235
Run by: Fred Hutchinson Cancer Center
People needed: 12
Starts: 2010-04-01
Last updated by the study team: 2011-12-21

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

FOR LEUKAPHERESIS:
Pulse > 45 or < 120
Weight >= 45 kg
Temperature =< 38 Celsius (C) (=< 100.4 Fahrenheit [F])
White blood cells (WBC) >= 3000
Hematocrit (HCT) >= 30%
Platelets >= 100,000
FOR T CELL INFUSION:
Histopathological documentation of melanoma concurrent with the diagnosis of metastatic disease
Tumor expression of MART-1 (2+ staining or > 25%) by immunohistochemistry (IHC)
Able to tolerate high-dose cyclophosphamide
Expression of human leukocyte antigen (HLA)-A2
Zubrod performance status of 0-1
Bi-dimensionally measurable disease by palpation on clinical exam, or radiographic imaging (X-ray, computed tomography [CT] scan)
Normal cardiac stress test within 182 days prior to enrollment is required of all patients over 50 years old or those with an abnormal electrocardiogram (ECG), any history of cardiac disease, a family history of cardiac disease or hypertension

You may not qualify if…

Pregnant women, nursing mothers, men or women of reproductive ability who are unwilling to use effective contraception or abstinence; women of childbearing potential must have a negative pregnancy test within two weeks prior to entry
Serum creatinine > 1.6 mg/dL or creatinine clearance (CrCl) < 75 ml/min (calculated: Cockcroft and Gault equation: CrCl = (140 - age) x ideal body weight (IBW)/(serum creatinine [Scr] x 72) (x 0.85 for females)
Serum glutamic oxaloacetic transaminase (SGOT) > 150 IU or > 3 x upper limit of normal
Direct bilirubin > 1.0 mg/dL
Prothrombin time > 1.5 x control (in the absence of systemic anticoagulation)
Clinically significant pulmonary dysfunction, as determined by medical history and physical exam; patients so identified will undergo pulmonary functions testing at the discretion of their primary physician
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 electrocardiogram (EKG) requiring drug therapy
Symptomatic central nervous system metastases greater than 1 cm at time of therapy; patients with 1-2 asymptomatic, less than 1cm brain/central nervous system (CNS) metastases without significant edema may be considered for treatment; if sub-centimeter CNS lesions are noted at study entry, then a repeat imaging will be performed if more than 3 weeks have elapsed from the last scan; patients will not be treated if CNS lesions are > 1 cm or if patient is symptomatic from brain metastasis
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
Chemotherapeutic agents (standard or experimental), radiation therapy, or other immunosuppressive therapies less than 3 weeks prior to T cell therapy; (patients with bulky disease may undergo cytoreductive chemotherapy but treatment will be discontinued at least 3 weeks prior to T cell therapy)
Clinically significant autoimmune disorders or conditions of immunosuppression; patients with acquired immunodeficiency syndrome (AIDS) or human immunodeficiency virus (HIV)-1 associated complex or known to HIV antibody seropositive or known to be recently polymerase chain reaction positive (PCR+) for hepatitis are not eligible for this study; virology testing will be done within 6 months of T cell infusion; the severely depressed immune system found in these infected patients and the possibility of premature death would compromise study objectives
Patients who, in the opinion of their physician, are not clinically suited for high-dose cytoxan

Where it is running

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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