Guadecitabine in Treating Patients With Higher-Risk Myelodysplastic Syndromes

Korábbi kezelés

• Current concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in the protocol
• Use of investigational agents within 30 days or any anticancer therapy within 2 weeks prior to entering this study with the exception of hydroxyurea; the patient must have recovered from all acute toxicities from any previous therapy
• Have any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system that may place the patient at undue risk to undergo treatment
• Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results
• Any concurrent malignancy
  • Exceptions
  • Patients with treated non-melanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia, regardless of the disease-free duration, are eligible for this study if definitive treatment for the condition has been completed
  • Patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease based on prostate-specific antigen (PSA) values are also eligible for this study if hormonal therapy has been initiated or a radical prostatectomy has been performed

Más betegség

• Patients with a systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment)

Egyéb

• Pregnant or lactating patients

• Patients with higher risk MDS (International Prognostic Scoring System [IPSS] int-2 or high; or >= 10% blasts as defined by World Health Organization [WHO])
  • No prior intensive chemotherapy or high-dose cytarabine (>= 1 g/m\^2)
  • Prior biologic therapies (=< 1 cycle of prior decitabine or azacitidine), targeted therapies, or single agent chemotherapy is allowed
  • Off chemotherapy for 2 weeks prior to entering this study with no toxic effects of that therapy, unless there is evidence of rapidly progressive disease
  • Hydroxyurea is permitted for control of counts prior to treatment
  • Hematopoietic growth factors are allowed
• Eastern Cooperative Oncology Group (ECOG) performance status =< 2
• Serum creatinine =< 1.5 mg/dL
• Serum bilirubin =< 1.5 x upper limit of normal (ULN)
• Aspartate transaminase (AST) or alanine transaminase (ALT) =< 2.5 x ULN
• Alkaline phosphatase =< 2.5 x ULN
• Provide signed written informed consent
• Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent
• Female patients of childbearing potential must have a negative pregnancy test within 2 weeks prior to entering this study
• Women who are able to become pregnant and men who can father a child must use birth control while on study and for at least 8 weeks after your last dose of study drug(s); acceptable birth control includes a condom or a diaphragm with spermicidal jelly; and birth control methods that are taken by mouth, injected, or implanted; if you are already using birth control, you must check with the study staff to make sure that it is considered one of the acceptable forms to use in this study