New drug combo targets tough leukemia cases

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Cytopathologically or histopathologically confirmed diagnosis of AML, MDS (RAEB-1, -2) or CMML, who are either relapsed or refractory to standard therapy, or are considered inappropriate candidates for standard therapy. * Inappropriateness for standard therapy requires a) MDS patients: not be a candidate for immediate allogeneic stem cell transplantation, not have a -5q-cytogenetic abnormality (unless previously received lenalidomide), and not be an appropriate candidate for a DNA hypomethylating agent b) AML patients must be 60 years of age or greater and have one of more of the following documented poor risk factors: ECOG Performance Status = 2, 70 years of age or older, unfavorable cytogenetics. * Life expectancy of at least 12 weeks * Not likely to require cytoreductive therapy within one month (other than hydroxyurea) * ECOG Performance Status of 2 or less * Serum transaminase activity (AST/SGOT \& ALT/SGPT) \< 2.5 x ULN * Serum total bilirubin \< 1.5 x ULN ( with the exception of individuals with Gilbert's disease) * INR \< 1.3 (or \< 3 on anticoagulants) * Fasting serum cholesterol 300mg/dl or 7.75 mmol/L or less AND fasting triglycerides 2.5 ULN or less Exclusion Criteria: * Prior allogeneic, syngeneic, or autologous bone marrow transplant or stem cell transplant less than 2 months previously * Female patients who are pregnant or breast feeding or adults of child bearing not employing double barrier contraception * Concurrent severe and/or uncontrolled medical or psychiatric condition which may interfere with the completion of the study * Impairment of gastrointestinal function or GI disease that may significantly alter absorption of PKC412 or RAD001 * Uncontrolled active infection * Any pulmonary infiltrate on teh baseline chest x-ray known to be new in the previous 4 weeks * Patients with a Grade 2 or higher hypercholesterolemia or hypertriglyceridemia despite lipid-lowering therapy * Patients with history of another malignancy within the past 5 years, with the exception of adequately treated basal or squamous cell skin carcinoma or cervical carcinoma in situ * History of non-compliance to medical regimens and patients who are unwilling or unable to comply with this protocol * Prior treatment with any investigational drug within preceding 4 weeks * Chronic treatment with systemic steroids or another immunosuppressive agent * Patients should not receive immunization with attenuated live vaccines within one week of study entry or during study period * Any severe or uncontrolled medical conditions or other conditions that could affect their participation * Known history of HIV seropositivity * Known hypersensitivity to RAD001 or other rapamycins or to its excipients * Known hypersensitivity to PKC412 or to its excipients * Diagnosis of acute promyelocytic leukemia