Status:
COMPLETED
PXD101 in Treating Patients With Relapsed or Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Recurrent Adult Burkitt Lymphoma
Recurrent Adult Diffuse Large Cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This phase II trial is studying how well PXD101 works in treating patients with relapsed or refractory aggressive B-cell non-Hodgkin's lymphoma. PXD101 may stop the growth of cancer cells by blocking ...
Detailed Description
PRIMARY OBJECTIVES: I. Evaluate response rate in patients with relapsed or refractory aggressive B-cell non-Hodgkin's lymphoma treated with PXD101. SECONDARY OBJECTIVES: I. Determine the toxicity o...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Biopsy-proven (no needle aspirations or cytologies) aggressive B-cell non-Hodgkin's lymphoma (NHL), including 1 of the following histology subtypes:
- Diffuse large cell NHL
- Burkitt's or Burkitt-like NHL
- Primary mediastinal NHL
- Relapsed or refractory disease
- Bidimensionally measurable disease
- Transformed NHL allowed
- Not eligible for stem cell transplantation (for patients registered to study at first relapse)
- No active CNS involvement by lymphoma
- Zubrod performance status 0-2
- No history of allergic reactions attributed to compounds of similar chemical or biologic composition to PXD101
- Absolute neutrophil count \>= 1,500/mm\^3
- Platelet count\>=100,000/mm\^3
- WBC \>= 3,000/mm\^3
- Creatinine \< 2 times upper limit of normal (ULN) OR creatinine clearance \>= 60 mL/min
- No significant EKG abnormalities
- Bilirubin normal
- SGOT/SGPT \< 2.5 times ULN (=\< 5 times ULN if liver involvement)
- No long QT syndrome or marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of QTc interval \> 500 msec)
- No other significant cardiovascular disease, including any of the following:
- Unstable angina pectoris
- Uncontrolled hypertension
- Congestive heart failure related to primary cardiac disease
- Any condition requiring anti-arrhythmic therapy
- Ischemic or severe valvular heart disease
- Myocardial infarction within the past 6 months
- No major surgery within 28 days prior to study entry
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No concurrent medication that may cause Torsades de Pointes (i.e., prolongation of the QT interval \> 500 msec)
- At least 14 days since prior radiotherapy
- At least 2 weeks since prior valproic acid or any other histone deacetylase inhibitor
- No clinical evidence of any of the following:
- Severe peripheral vascular disease
- Diabetic ulcers or venous stasis ulcers
- History of deep venous or arterial thrombosis within the past 3 months
- Radioimmunotherapy is considered a chemotherapy regimen
- Single-agent rituximab is not considered a chemotherapy regimen
- Standard salvage chemotherapy followed by autologous stem cell transplantation is considered 1 regimen
- No known AIDS or HIV-associated complex
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or in situ carcinoma of the cervix
- At least 2 weeks since prior therapy and recovered
- No more than 5 prior chemotherapy regimens
Exclusion
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00303953
Start Date
January 1 2006
End Date
August 1 2010
Last Update
May 12 2014
Active Locations (123)
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1
Providence Hospital
Mobile, Alabama, United States, 36608
2
University of Arizona Health Sciences Center
Tucson, Arizona, United States, 85724
3
NEA Baptist Memorial Hospital
Jonesboro, Arkansas, United States, 72401
4
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205