Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-25 @ 5:01 AM
NCT ID:
NCT01468818
Eligibility Criteria:
* INCLUSION CRITERIA:
* Measurable metastatic melanoma with available autologous tumor infiltrating lymphocytes (TIL).
* 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.
* Able to understand and sign the Informed Consent Document
* Clinical performance status of Eastern Cooperative Oncology Group (ECOG) 0 or 1.
* Life expectancy of greater than three months
* 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 receiving the treatment.
* Serology:
* Seronegative for human immunodeficiency virus (HIV) antibody. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who are HIV seropositive can have decreased immune-competence and thus be less responsive to the experimental treatment and more susceptible to its toxicities.)
* Seronegative for hepatitis B antigen, and seronegative for hepatitis C antibody. If hepatitis C antibody test is positive, then patient must be tested for the presence of antigen by reverse transcription-polymerase chain reaction (RT-PCR) and be hepatitis C virus ribonucleic acid (HCV RNA) negative.
* Women of child-bearing potential must have a negative pregnancy test because of the potentially dangerous effects of the treatment on the fetus.
* Hematology
* Absolute neutrophil count greater than 1000/mm(3) without the support of filgrastim
* White blood cell (WBC) greater than or equal to 3000/mm(3)
* Platelet count greater than or equal to 100,000/mm(3)
* Hemoglobin \> 8.0 g/dl
* Chemistry:
* Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) less than or equal to to 2.5 times the upper limit of normal
* Serum Creatinine less than or equal to to 1.6 mg/dl
* Total bilirubin less than or equal to to 1.5 mg/dl, except in patients with Gilberts Syndrome who must have a total bilirubin less than 3.0 mg/dl.
* 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).
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 or as specified in the eligibility criteria.
* Six weeks must have elapsed since any prior antibody therapy including anti-cytotoxic T-lymphocyte antigen 4 (CTLA4) antibody therapy that could affect any anti-cancer immune response, at the time the patient receives the preparative regimen to allow antibody levels to decline. NOTE: patients who have previously received ipilimumab and have documented gastrointestinal (GI) toxicity must have a colonoscopy with normal colonic biopsies.)
* Patients must be ineligible to receive interleukin-2 (IL-2) based on evidence that may include ischemic heart disease, or arrhythmias, or poor ventricular ejection fraction (\< 50%), or respiratory compromise (forced expiratory volume in 1 second (FEV1) \< 60%), or clinically significant patient history which in the judgment of the investigator would compromise the patients ability to tolerate aldesleukin.
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).
* Concurrent systemic steroid therapy.
* History of severe immediate hypersensitivity reaction to any of the agents used in this study.
* Patients with a ventricular ejection fraction (less than or equal to 30%), or respiratory compromise (FEV1 less than or equal to 40%).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01468818
Study Brief:
Protocol Section:
NCT01468818