A Phase I Study of MGCD0103 Given Three-Times Weekly In Patients With Leukemia Or Myelodysplastic Syndromes
Leukemia, Myelodysplastic Syndromes
About this trial
This is an interventional treatment trial for Leukemia focused on measuring Leukemia, Myelodysplastic Syndromes, Phase I
Eligibility Criteria
Inclusion Criteria: Patients must have a diagnosis of one of the following: relapsed or refractory AML or ALL that has failed to respond to standard therapy, has progressed despite standard therapy relapsed or refractory Myelodysplastic Syndromes previously untreated AML or Myelodysplastic Syndromes in patients > 60 years of age who refused or are not candidates for induction chemotherapy Patients with relapsed or refractory CML that has failed to respond to Imatinib therapy or standard therapy, has progressed despite standard therapy, or for which no standard therapy exists ECOG performance status of 0, 1, or 2 Age ≥ 18 years Patients or their legal representative must be able to read, understand, and sign a written informed consent (approved by the IRB/EC) prior to study entry Exclusion Criteria: Patients with a history of another cancer other than basal cell carcinoma or cervical intraepithelial neoplasia Pregnant or lactating women Patients and their partners, if either are of childbearing potential, not using adequate birth control measures throughout the study and for 90 days following the last dose of study medication Patients with known meningeal metastasis(es) Patients with active or uncontrolled infections, or with a fever >38.5 C Patients with serious illnesses, medical conditions, or other medical history, which would be likely to interfere with a patient's participation in the study Patients who have been treated with any investigational drug or anti-cancer therapy within 30 days of study start.
Sites / Locations
- Anderson Cancer Center
- Princess Margaret Hospital
- Sir Mortimer Davis-Jewish General Hospital
Arms of the Study
Arm 1
Experimental
1