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Phase 2 N=22 Treatment

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

Recurrent Adult Burkitt Lymphoma · Recurrent Adult Diffuse Large Cell Lymphoma

Enrolled (actual)
22
Serious AEs
15.0%
Results posted
Sep 2012
Primary outcome: Primary: Assess Number of Patients Who Achieve Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR) — 0; 0; 0; 20 participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
belinostat (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
National Cancer Institute (NCI)
Primary completion
Jan 2010

Outcome Measures

OutcomeResultp-value
PRIMARY
Assess Number of Patients Who Achieve Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR)
0; 0; 0; 20
SECONDARY
Overall Survival
0.9
SECONDARY
Progression-free Survival
0.2

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.

Eligibility 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 = 60 mL/min
  • No significant EKG abnormalities
  • Bilirubin normal
  • SGOT/SGPT 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00303953). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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