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:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2025-12-24 @ 5:39 PM
NCT ID:
NCT00329368
Eligibility Criteria:
Inclusion Criteria:
* Have a histologically confirmed diagnosis of metastatic or refractory cancer for which there are no effective standard therapeutic options available, (Note: for patients accrued at Southern Illinois University, a diagnosis of renal (i.e., kidney) carcinoma is required.)
* Have signed an Institutional Review Board (IRB) approved informed consent form (ICF) prior to performing any study evaluation/procedures
* Be \> or = 18 years of age and women must either be 1) not of childbearing potential or 2) have a negative serum pregnancy test within 7 days prior to commencing treatment. Patients are considered not of childbearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or they are postmenopausal (12 consecutive months of amenorrhea \[lack of menstruation\])
* (If applicable) Have completed prior cytotoxic chemotherapy, radiotherapy or immunotherapy or experimental therapy \> or = 30 days prior to the study enrollment, and recovered form associated toxicities
* Have an Eastern Cooperative Oncology Group (ECOG) score of \< or = 2, and an anticipated life expectancy of at least 6 months
* Have adequate hematologic function, as defined by an absolute or calculated neutrophil count \> or = 1500/microL, platelet count \> or = 100000/microL, lymphocyte count \> or = 500/microL, and hemoglobin level \> or = 10 g/dL. Patients may not receive prophylactic transfusion in order to qualify for trial eligibility
* Have adequate renal function, as defined by a documented serum creatinine of \< or = 2.0mg/dL. Greater than "1+" proteinuria will require microscope evaluation and the results discussed with the medical monitor prior to patient enrollment; or if serum creatine is \>2.0, patient must have an actual or calculated 24-hour creatinine clearance of \>60mL/min and no obvious evidence of concurrent medullary cystic disease or obstructive uropathy
* Have adequate hepatic function, as defined by a total bilirubin level \< or = 1.5 x upper limit of normal (ULN) and alkaline phosphatase, aspartate transaminase (AST), and alanine transaminase (ALT) levels \< or = 2.5 x ULN. If alkaline phosphatase is outside of these parameters and is due to bone metastases (as verified by the assessment of isoenzymes), then the patient is eligible.
Exclusion Criteria:
* Have previously participated in a FolateImmune trial
* Have a history of severe hypersensitivity (grade 3 - 4 allergic reaction) to fluorescein or any drug, radiologic contrast agent, insect bite, food, cytokines, or any other agent; or have received fluorescein within 30 days of the study.
* Have medical conditions that preclude the use of IL-2 or IFN-alpha. These conditions include but are not limited to, diabetes mellitus with a history of progression to diabetic ketoacidosis, history of severe coagulation disorder, psoriasis, sarcoidosis, retinal hemorrhage, symptomatic pulmonary disease, heart failure (\> or = New York Heart Association NYHA class II), or transplant requiring immunosuppressive therapy
* Be pregnant or breast-feeding
* Be currently receiving an experimental drug, or used an experimental device within 30 days of study entry
* Be currently undergoing chemotherapy, anticancer hormonal therapy, and/or therapy with immunosuppressant agents
* Have any concomitant malignancy with the exception of basal cell or squamous cell carcinoma of skin
* Have radiographically documented evidence of current brain metastases, a history of stem cell transplant, immunodeficiency, and/or a medical or psychiatric illness (that in the investigator's opinion, would prevent adequate compliance with study therapy or evaluation of the endpoints)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00329368
Study Brief:
Protocol Section:
NCT00329368