Status:
TERMINATED
Panobinostat in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia
Lead Sponsor:
City of Hope Medical Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Panobinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying the side effects of panobinostat and to se...
Detailed Description
OBJECTIVES: Primary * To determine the antitumor activity of panobinostat, in terms of objective response rate, time to progression, and survival, in patients with relapsed or refractory acute lymph...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed acute myeloid leukemia or acute lymphoblastic leukemia (ALL)
- Relapsed or refractory disease
- Patients with Philadelphia chromosome-positive (Ph+) ALL refractory to BCR/ABL inhibitors are eligible
- Patients who have relapsed after prior autologous or allogenic stem cell transplant are eligible
- No active CNS disease
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Serum albumin ≥ 3 g/dL
- AST and ALT ≤ 2.5 times upper limit of normal (ULN) (5.0 times ULN if transaminase elevation is due to leukemic involvement)
- Bilirubin ≤ 1.5 times ULN
- Creatinine ≤ 1.5 times ULN or creatinine clearance ≥ 50 mL/min
- Potassium ≥ lower limit of normal (LLN)
- Phosphorous ≥ LLN
- Serum total calcium (corrected for serum albumin) or serum ionized calcium ≥ LLN
- Magnesium ≥ LLN
- Thyroid stimulating hormone and free T4 normal (thyroid hormone replacement therapy allowed)
- LVEF ≥ LLN by MUGA or ECHO
- No impaired cardiac function, including any of the following:
- QTc \> 450 msec
- Congenital long QT syndrome
- History of sustained ventricular tachycardia
- History of ventricular fibrillation or torsades de pointes
- Bradycardia (i.e., heart rate \< 50 beats per minute)
- Pacemaker allowed provided heart rate ≥ 50 beats per minute
- Myocardial infarction or unstable angina within the past 6 months
- New York Heart Association class III-IV congestive heart failure
- Right bundle branch block and left anterior hemiblock (bifascicular block)
- No uncontrolled hypertension
- No unresolved diarrhea \> CTCAE grade 1
- No impaired gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral panobinostat
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective double-barrier contraception during and for 3 months after completion of study treatment
- No other primary malignancy within the past 5 years, other than curatively treated carcinoma in situ of the cervix or basal cell or squamous cell carcinoma of the skin
- No HIV or hepatitis C positivity
- No other concurrent severe and/or uncontrolled medical condition
- No significant history of non-compliance to medical regimens or inability to give reliable informed consent
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Recovered from all prior therapy
- More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C) or radiotherapy
- More than 4 weeks since prior valproic acid
- No other prior treatment with a histone deacetylase inhibitor
- No concurrent medication that may cause QTc prolongation or induce torsades de pointes
- No concurrent CYP3A4 inhibitors
- No concurrent grapefruit, grapefruit juice, or Seville (sour) oranges
- No concurrent radiotherapy
- No other concurrent anticancer therapy or investigational therapy
Exclusion
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00723203
Start Date
April 1 2008
End Date
September 1 2010
Last Update
September 9 2014
Active Locations (2)
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1
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
2
South Pasadena Cancer Center
Pasadena, California, United States, 91030