Melanoma Treatment With White Blood Cells That Destroy MART Expressing Tumor Cells

Stopped early · Phase 2

Conditions studied: Metastatic Melanoma, Skin Cancer

In brief

Background: \- Some cancer treatments collect a patient s own blood cells to use as specialized cancer-fighting cells. Collected white blood cells known as PBL (peripheral blood lymphocytes) can use to isolate special cells that can fight tumors. Before treatment with PBL, chemotherapy is given to destroy existing white blood cells so that the new cells can survive and attack the tumors. After PBL treatment, aldesleukin is given to help the new cells grow. Researchers want to see if special white blood cells that recognize a specific protein that is present in melanoma cells (melanoma antigen recognized by T cells (MART)) can cause tumors to shrink. These white blood cells will be tested with and without aldesleukin. Objectives: * To test the safety and effectiveness of white blood cells that target MART in the treatment of melanoma. * To test white blood cells that target MART with and without aldesleukin. Eligibility: \- Individuals at least 18 years of age who have melanoma that has not responded to standard treatments. Design: * Participants will be screened with a medical history and physical exam. Blood and urine samples will be taken. Imaging studies such as x-rays or magnetic resonance imaging scans will be performed. * Participants will provide white blood cells through leukapheresis. Researchers will attempt to isolate white blood cells that recognize MART * Seven days before the start of treatment, participants will have chemotherapy. * After the last dose of chemotherapy, participants will receive the MART reactive PBL cells. Filgrastim doses will also be given to help white blood cell counts return to normal. Participants will have frequent blood tests. * Participants who are able to have aldesleukin treatment will start within 24 hours after receiving the MART reactive PBL cells. Treatment will continue for up to 5 days. * Participants may have an optional tumor or lymph node biopsy to study the effects of treatment. * If the tumor continues to grow after MART PBL treatment, participants may have one more round of cell collection and treatment. * Participants will have followup visits for up to 6 months after receiving the MART reactive PBL treatment.

Key facts

Study ID

NCT01495572

Run by

National Cancer Institute (NCI)

People needed

5

Starts

2011-12-01

Expected to finish

2014-02-01

Last updated by the study team

2015-10-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the treatment on the fetus or infant.
• Systemic steroid therapy required.
• Active systemic infections, coagulation disorders or other active major medical illnesses of the cardiovascular, respiratory or immune system, as evidenced by a positive stress thallium or comparable test, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease.
• Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease).
• Opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities.)
• History of severe immediate hypersensitivity reaction to any of the agents used in this study.
• The following patients will be excluded from the high-dose aldesleukin arm (but may be eligible for cells alone arm):
• History of coronary revascularization or ischemic symptoms
• Any patient known to have an left ventricular ejection fraction (LVEF) less than or equal to 45 percent.
• Documented LVEF of less than or equal to 45 percent tested in patients with:
• Clinically significant atrial and/or ventricular arrhythmias including but not limited to: atrial fibrillation, ventricular tachycardia, second or third degree heart block
• Age greater than or equal to 60 years old
• Documented forced expiratory volume in 1 second (FEV1) less than or equal to 60 percent predicted tested in patients with:
• A prolonged history of cigarette smoking (20 pk/yrs of smoking within the past 2 years)
• Symptoms of respiratory dysfunction
• Clinically significant patient history which in the judgment of the Principal Investigator would compromise the patients ability to tolerate aldesleukin

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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