Status:
ACTIVE_NOT_RECRUITING
RAD001 in Combination With PKC412 in Patients With Relapsed, Refractory or Poor Prognosis AML or MDS
Lead Sponsor:
Richard Stone, MD
Collaborating Sponsors:
Beth Israel Deaconess Medical Center
Massachusetts General Hospital
Conditions:
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this research study is to determine the safety of the combination of RAD001 and PKC412 as a cancer treatment, and to establish the highest dose of RAD001 that can be given in conjunctio...
Detailed Description
* This is a dose-escalation study in which 3 participants will be given a particular starting dose of RAD001 on a certain schedule. If the dose and schedule are well tolerated, then the next 3 partici...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00819546
Start Date
January 1 2009
End Date
December 1 2025
Last Update
February 27 2025
Active Locations (3)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
3
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215