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Phase II Study of PXD101 (NSC-726630) in Relapsed and Refractory Aggressive B-Cell Lymphomas

Phase 2
18 Years
Not Enrolling
Recurrent Adult Burkitt Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma

Thank you

Trial Information

Phase II Study of PXD101 (NSC-726630) in Relapsed and Refractory Aggressive B-Cell Lymphomas


I. Evaluate response rate in patients with relapsed or refractory aggressive B-cell
non-Hodgkin's lymphoma treated with PXD101.


I. Determine the toxicity of this drug in these patients. II. Estimate the 6-month
progression-free survival rate in patients treated with this drug.


I. Determine the major histocompatability complex of class II proteins (HLA-DR, -DP, -DQ),
TUNEL, and CD8 infiltration status, by immunochemistry on paired pre- and post-treatment
tumor samples, in the first 20 patients enrolled.

II. Measure CIITA and HLA-DR mRNA expression using quantitative reverse
transcriptase-polymerase chain reaction and determine, preliminarily, the associations of
these markers with progression-free survival.

III. Evaluate paired pre- and post-treatment peripheral blood mononuclear cells from
patients for histone acetylation status and determine correlation with findings from
duplicate experiments on pre- and post-needle core biopsies.

OUTLINE: This is a multicenter study.

Patients receive PXD101 IV over 30 minutes on days 1-5. Treatment repeats every 21 days for
up to 2 years in the absence of disease progression or unacceptable toxicity.

Needle core biopsies and peripheral blood mononuclear cells are obtained from the first 20
patients pre- and post-treatment for biomarker correlative studies.

After completion of study treatment, patients are followed every 3-6 months for up to 3

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

- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Assess Number of Patients Who Achieve Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR)

Outcome Description:

Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the SPD for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.

Outcome Time Frame:

assessed at week 8, and every 3 months for 3 years

Safety Issue:


Principal Investigator

Steven Bernstein

Investigator Role:

Principal Investigator

Investigator Affiliation:

Southwest Oncology Group


United States: Food and Drug Administration

Study ID:




Start Date:

January 2006

Completion Date:

Related Keywords:

  • Recurrent Adult Burkitt Lymphoma
  • Recurrent Adult Diffuse Large Cell Lymphoma
  • Burkitt Lymphoma
  • Lymphoma
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell



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