Phase 2
N=22
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
Bottom Line
View on ClinicalTrials.gov: NCT00303953 ↗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
| Outcome | Result | p-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
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.