PXD101 in Treating Patients With Relapsed or Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

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 some of the enzymes needed for cell growth and by blocking blood flow to the cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Belinostat

Criteria

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