Status:
COMPLETED
Panobinostat (LBH589) and Imatinib Mesylate in Treating Patients With Previously Treated Chronic Phase Chronic Myelogenous Leukemia
Lead Sponsor:
City of Hope Medical Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
RATIONALE: Panobinostat and imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase I trial is studying the side effects and ...
Detailed Description
OBJECTIVES: Primary * To determine the safety and tolerability of LBH589 given in combination with imatinib mesylate in CML patients who are in Major Cytogenetic Remission (MCR) with residual BCR-AB...
Eligibility Criteria
Inclusion
- Ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed
- CML CP patients who have been treated with and tolerated Imatinib for 1 year or more, have achieved at least major cytogenetic response and continue to be BCR-ABL positive (Patients should be receiving Imatinib at a dose of 400 daily at the time of entry into the study)
- ANC and PLT need to be in the normal range
- Serum albumin \>= 3g/dL
- AST/SGOT and ALT/SGPT =\< 2.5 x upper limit of normal (ULN)
- Serum bilirubin =\< 1.5 x ULN
- Serum creatinine =\< 1.5 x ULN or 24-hour creatinine clearance \>= 50 ml/min
- Serum potassium \>= lower limit of normal (LLN)
- Serum phosphorus \>= LLN
- Serum total calcium (corrected for serum albumin) or serum ionized calcium \>= LLN
- Serum magnesium \>= LLN
- ECOG performance status of =\< 2
Exclusion
- Prior treatment with an HDAC inhibitor
- Patient who have been treated with Imatinib \< 1 year or patients are currently being treated with Imatinib at a dose \> 400 mg daily
- Impaired cardiac function including any one of the following: Screening ECG with a QTc \> 450 msec; Patients with congenital long QT syndrome; History or presence of sustained ventricular tachycardia; Any history of ventricular fibrillation or torsades de pointes; Bradycardia defined as heart rate \< 50 beats per minute (patients with a pacemaker and heart rate \>= 50 beats per minute are eligible); Patients with a myocardial infarction or unstable angina within 6 months of study entry; Congestive heart failure (NY Heart Association class III or IV); Right bundle branch block and left anterior hemiblock (bifascicular block)
- Uncontrolled hypertension
- Concomitant use of drugs with a risk of prolonging the QT interval or inducing torsades de pointes
- Concomitant use of CYP3A4 inhibitors
- Patients with unresolved diarrhea \> CTCAE grade 1
- Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral LBH589
- Other concurrent severe and/or uncontrolled medical conditions
- Patients who have received chemotherapy, any investigational drug or undergone major surgery \< 4 weeks prior to starting study drug or who have not recovered from side effects of such therapy
- Concomitant use of any other anti-cancer therapy or radiation therapy
- Patients being treated with Coumadin (unless patients who require anticoagulation can be switched to a low-molecular weight or standard heparin)
- Female patients who are pregnant or breast feeding or patients of reproductive potential not willing to use a double method of contraception including a barrier method (i.e. condom) during the study and 3 months after the end of treatment (Women of childbearing potential \[WOCBP\] must have a negative serum pregnancy test within 7 days of the first administration of oral LBH589)
- Male patients whose sexual partners are WOCBP not willing to use a double method of contraception including condom during the study and 3 months after the end of treatment
- Patients with a history of another primary malignancy within 5 years other than curatively treated CIS of the cervix, or basal or squamous cell carcinoma of the skin
- Patients with known positivity for human immunodeficiency virus (HIV) or hepatitis C; baseline testing for HIV and hepatitis C is not required
- Patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00686218
Start Date
May 1 2008
End Date
August 1 2014
Last Update
August 15 2014
Active Locations (3)
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1
City of Hope Medical Center
Duarte, California, United States, 91010-3000
2
South Pasadena Cancer Center
South Pasadena, California, United States, 91030
3
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109