A Phase II Clinical Trial of PXD101 in Patients With Recurrent or Refractory Cutaneous and Peripheral T-Cell Lymphomas

Not Recruiting

Trial ID: NCT00274651


Open-label, non-randomized trial to assess the effectiveness of PXD101 in patients with recurrent or refractory cutaneous or peripheral and other types of T-cell lymphomas. PXD101 is a new, potent histone deacetylase (HDAC) inhibitor. Patients are treated with belinostat(PXD101) 1000 mg/m2 on days 1-5 of a 21 day cycle.

Official Title

A Phase II Clinical Trial of PXD101 in Patients With Recurrent or Refractory Cutaneous and Peripheral T-Cell Lymphomas

Stanford Investigator(s)


Inclusion Criteria:

   - Male or female with age > or = 18 years.

   - Histologically confirmed diagnosis of cutaneous T-cell lymphoma (CTCL) or peripheral
   T-cell lymphoma (PTCL) or other T-cell non-Hodgkin's lymphoma (NHL).

   - Must have failed at least one line of prior systemic therapy. No limitation in number
   of prior therapies. CTCL patients who are refractory or intolerant to oral Targretin
   are also eligible.

   - The presence of measurable disease (defined as > or = 1 cm with radiographic imaging)
   for PTCL or stage 1B or greater disease for CTCL and assessable by the
   severity-weighted assessment tool (SWAT).

   - Adequate bone marrow and hepatic function including the following:

      - Absolute neutrophil count > or = 1,000 cells/mm3, platelets > or = 40,000/mm3

      - Total bilirubin < or = 1.5 x upper normal limit or < or = 3 x upper normal limit
      if hepatic involvement

      - AST (SGOT) (aspartate aminotransferase), ALT (SGPT) (alanine aminotransferase) <
      or = 2.5 x upper normal limit (< or = 5 x upper normal limit if hepatic

      - Hemoglobin > or = 9.0 g/dL.

   - Serum potassium within normal range.

   - Karnofsky performance status > or = 70%.

   - Estimated life expectancy > 3 months.

   - Signed informed consent approved by the Institutional Review Board (IRB).

Exclusion Criteria:

   - Anti-cancer therapies within 4 weeks of first PXD101 administration should be excluded
   unless toxicity from prior anti-cancer therapy has resolved or returned to baseline
   and cancer disease status warrants.

   - Any use of investigational drugs within 4 weeks prior to study registration.

   - Major surgery within 4 weeks of study drug administration.

   - Prior allogeneic bone marrow transplant.

   - A diagnosis of adult T-cell lymphoma/leukemia (ATLL) or precursor T-lymphoblastic

   - Co-existing active infection or any co-existing medical condition likely to interfere
   with trial procedures. However, patients with progressing CTCL whose open skin lesions
   are frequently infected may not be excluded from this trial at the discretion of

   - Clinically significant cardiovascular disease including unstable angina pectoris,
   uncontrolled hypertension, and congestive heart failure related to primary cardiac
   disease, a condition requiring anti-arrhythmic therapy, history of sustained
   ventricular tachycardia, history of ventricular fibrillation or Torsade de Pointes,
   bradycardia (HR<50bpm) with or without a pacemaker, bifascicular block with a right
   bundle branch block and a left anterior block, ischemic or severe valvular heart
   disease, a myocardial infarction within 6 months or a left ventricular ejection
   fraction < 40% (by echocardiogram [ECHO] or multigated acquisition scan [MUGA]) within
   3 months of study enrolment.

   - A marked baseline prolongation of QT/QTc ((corrected) QT) interval, e.g., repeated
   demonstration of a QTc interval > 450 milliseconds (msec). Long QT Syndrome; the
   required use of concomitant medication on belinostat infusion days that may cause
   Torsade de Pointes.

   - Renal insufficiency defined as a calculated creatinine clearance of < 45 mL/min/1.73

   - A history of allergic reactions attributed to compounds of similar chemical or
   biological composition to PXD101 and L-arginine.

   - Clinically significant central nervous system disorders with altered mental status or
   psychiatric disorders precluding understanding of the informed consent process and/or
   completion of the necessary studies.

   - Patients requiring treatment for other malignant diseases or less than 5 years
   post-treatment completion for an invasive malignant disease (excluding non-melanotic
   skin cancers or cervical cancer in-situ). Patients with any history of melanoma should
   be excluded.

   - Pregnant or breast-feeding women, and women of childbearing age and potential, who are
   not willing to use effective contraception. Male patients and/or their fertile female
   partners who are not willing to use contraceptives during the trial.

   - Known infection with HIV, human T-cell leukemia virus type-1 (HTLV-1), hepatitis B or
   hepatitis C.


drug: belinostat

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Sipra Choudhury

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