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Background:
Objectives:
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Full description
Background:
Objectives:
Eligibility:
Design:
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
-INCLUSION CRITERIA:
Measurable metastatic melanoma with at least one lesion that is resectable for tumor infiltrating lymphocytes (TIL) generation and at least one other lesion that can be measured by Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
Confirmation of diagnosis of metastatic melanoma by the Laboratory of Pathology of National Cancer Institute (NCI).
Patients with 3 or fewer brain metastases that are less than 1 cm in diameter and asymptomatic are eligible. Lesions that have been treated with stereotactic radiosurgery must be clinically stable for 1 month after treatment for the patient to be eligible. Patients with surgically resected brain metastases are eligible.
Greater than or equal to 18 years of age and less than or equal to 70 years of age.
Ability of subject to understand and the willingness to sign the Informed Consent Document
Willing to sign a durable power of attorney.
Clinical performance status of Eastern Cooperative Oncology Group (ECOG) 0, 1 or 2.
Patients of both genders must be willing to practice birth control from the time of enrollment on this study and for up to four months after treatment.
Serology:
Women of child-bearing potential must have a negative pregnancy test because of the potentially dangerous effects of the treatment on the fetus.
Hematology:
Chemistry:
More than four weeks must have elapsed since any prior systemic therapy at the time the patient receives the preparative regimen, and patients toxicities must have recovered to a grade 1 or less (except for toxicities such as alopecia or vitiligo). Patients must have progressive disease after prior treatment.
Note: Patients may have undergone minor surgical procedures within the past 3 weeks, as long as all toxicities have recovered to grade 1 or less.
Subjects must be co-enrolled in 03-C-0277
EXCLUSION CRITERIA:
Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the treatment on the fetus or infant.
Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease).
Concurrent 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).
Active systemic infections, (e.g.: requiring anti-infective treatment), coagulation disorders or any other active major medical illnesses.
Concurrent systemic steroid therapy.
History of severe immediate hypersensitivity reaction to any of the agents used in this study.
History of coronary revascularization or ischemic symptoms.
Any patient known to have an left ventricular ejection fraction (LVEF) less than or equal to 45%
Documented LVEF of less than or equal to 45%, note: testing is required in patients with:
Patients who are receiving other investigational agents
Documented forced expiratory volume (FEV1) less than or equal to 60% predicted tested in patients with:
Primary purpose
Allocation
Interventional model
Masking
33 participants in 5 patient groups
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Data sourced from clinicaltrials.gov
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