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

Stopped early · Phase 2

Conditions studied: Cutaneous T-Cell Lymphoma, Peripheral T-Cell Lymphoma, Non-Hodgkin's Lymphoma

In brief

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.

Key facts

Study ID

NCT00274651

Run by

Valerio Therapeutics

People needed

53

Starts

2006-01-01

Expected to finish

2009-07-01

Last updated by the study team

2015-07-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 involvement)
• 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).

You may not qualify if…

• 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 lymphoma.
• 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 Investigators.
• 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 m2.
• 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.

Where it is running

• Leland Stanford Junior University — Stanford, California, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• Kansas City Cancer Center — Lenexa, Kansas, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Boston University Medical Center — Boston, Massachusetts, United States
• NYU Medical Center — New York, New York, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• Hopitaux du Haut Leveque — Pessac, France
• Hospital Purpan — Toulouse, France
• Universitatsklinikum Essen — Essen, Germany
• Hadassah University Hospital Ein Kerem — Jerusalem, Israel
• Rabin Medical Center — Petah Tikva, Israel
• Songklanagarind Hospital, Prince of Songkla University — Hat Yai, Thailand
• King Chulalongkorn Memorial Hospital — Patumwan, Thailand

Full record on ClinicalTrials.gov

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