Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Genzyme, a Sanofi Company
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Have a pathologic diagnosis of advanced solid tumors
After MTD is established, patients must have a measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) criteria
Be greater than or equal to 18 years old
You may not be if
Have a Karnofsky Performance Status (KPS) greater than or equal to 70
Have an estimated life expectancy of greater than or equal to 12 weeks
Have a negative serum or urine pregnancy test within 7 days of study enrollment (if patient is a female of childbearing potential)
Male and female patients who are fertile must agree to use an effective barrier method of birth control (latex condom, diaphragm, cervical cap, etc.) to avoid pregnancy
Sign a written informed consent form
Able to comply with study procedures and follow-up examinations
Have adequate organ function as indicated by the following laboratory values, obtained within 2 weeks prior to registration: ANC: greater than or equal to 1.5 × 10 9th/L; Platelets: greater than or equal to 100 × 10 9th/L; Serum bilirubin: less than 2.0 mg/dL; AST and ALT: less than 3 x ULN (Institutional Upper Limit of Normal) without liver involvement OR less than 5 x ULN(\*) with liver involvement; Serum creatinine: less than 2.0 mg/dL; Echocardiogram shortening fraction: greater than or equal to 28%(Not on pharmacologic support); or Ejection fraction greater than or equal to 50% (Not on pharmacologic support).
Received previous treatment with clofarabine.
Have an active, uncontrolled systemic infection considered opportunistic, life threatening, or clinically significant at the time of treatment.
Prior malignancy with less than a 2-year disease-free interval, except for adequately treated basal cell or squamous cell skin cancer; or in situ cancer of the cervix.
Are pregnant or lactating.
Have a psychiatric disorder(s) that would interfere with consent, study participation, or follow-up.
Have received any chemotherapy, major surgery, or irradiation, whether conventional or investigational, \< 4 weeks before enrollment in this study (6 weeks for mitomycin-C or nitrosourea) and/or have not recovered from acute toxicities of all previous therapy prior to enrollment.
Have any other severe concurrent disease, which, in the judgment of the investigator, would make the patient inappropriate for entry into this study (eg, uncontrolled severe insulin-dependent diabetes, uncontrolled hypertension, transient ischemic attacks, uncontrolled symptomatic coronary artery disease, etc.).
Have received prior radiation therapy to greater than or equal to 25% of the bone marrow (eg, no whole pelvic irradiation is allowed) and have not recovered from the acute side effects of radiotherapy.
Have received prior radiation therapy to the mediastinal region.
Have a broncho-alveolar pattern evident on chest x-ray.
Have symptomatic or untreated central nervous system (CNS) metastases.
