Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Alaunos Therapeutics
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Age ≥18 years
Histological or cytological documentation of cancer
Measurable disease
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
Ifosfamide and doxorubicin naïve
Life expectancy of at least 12 weeks
Adequate bone marrow, liver, and renal function, as assessed by the following laboratory requirements conducted within 7 days prior to dosing:Hemoglobin \>9.0 g/dL, Absolute neutrophil count (ANC) \>1,500/mm3,Platelet count ≥100,000/mm3,Total bilirubin \<1.5×ULN,ALT and AST ≤2.5×ULN,Partial thromboplastin \[PT\]-INR/activated partial thromboplastin time \[PTT\] \<1.5×ULN. Subjects who are being therapeutically anticoagulated with an agent such as Coumadin (warfarin sodium) or heparin are allowed provided there is no prior evidence of underlying abnormality in coagulation parameters. If an interaction between study drug and anticoagulant is suspected, anticoagulation monitoring should be increased as appropriate. Serum creatinine ≤ULN
Written, informed consent must be obtained from a potential subject prior to the conduct of any study-specific procedures
Male and female subjects must agree to use adequate birth control measures/barrier control during the course of the trial.
Women of childbearing potential must have a pregnancy test performed within 7 days of the start of treatment.
You may not be if
Clinically evident congestive heart failure \>Class II of the New York Heart Association (NYHA) guidelines
Serious, clinically significant cardiac arrhythmias, defined as the existence of an absolute arrhythmia, or ventricular arrhythmias classified as Lown III, IV, or V
History and/or signs of active coronary artery disease/ischemia with or without angina pectoris
Serious myocardial dysfunction defined as scintigraphically (MUGA, myocardial scintigram) determined absolute left ventricular ejection fraction (LVEF) below 45% or an LVEF below the normal limit (one or both criteria is sufficient for exclusion)
History of HIV infection
Prior nephrectomy of history of urinary tract obstruction
Any major surgery within 3 weeks prior to start of treatment
Metastatic brain or meningeal tumors, unless the subject is \>6 months from definitive therapy and has a negative imaging study within 4 weeks of study entry. In addition, the subject must not be undergoing acute steroid therapy or taper (chronic steroid therapy is acceptable, provided the dose is stable for 1 month prior to study start, and following screening radiographic studies).
History of seizure disorder (a subject with seizures related to brain metastasis will be allowed provided he/she has been seizure-free for at least 2 months and meets the criteria defined above for inclusion of subjects with brain metastasis)
Previous malignancy (except cervical carcinoma in situ, adequately treated basal cell carcinoma, or superficial bladder tumors \[Ta, Tis, \& T1\] or other malignancies curatively treated \>3 years prior to entry)
Pregnancy or lactation
Substance abuse or medical, psychological, or social conditions that may interfere with the subject's participation in the study or evaluation of the study results
Any condition that is unstable or could jeopardize the safety of a subject and his/her compliance with the protocol requirements
