A Phase II Clinical Trial of PXD101 in Patients With Recurrent or Refractory Cutaneous and Peripheral T-Cell Lymphomas (PXD101-CLN-6)
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ClinicalTrials.gov Identifier: NCT00274651 |
Recruitment Status :
Terminated
(Enrollment stopped prior to reaching expected number of patients, study had accumulated sufficient data to allow a registration study in PTCL (PXD101-CLN-19))
First Posted : January 11, 2006
Results First Posted : October 27, 2014
Last Update Posted : July 28, 2015
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Condition or disease | Intervention/treatment | Phase |
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Cutaneous T-Cell Lymphoma Peripheral T-Cell Lymphoma Non-Hodgkin's Lymphoma | Drug: belinostat | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 53 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase II Clinical Trial of PXD101 in Patients With Recurrent or Refractory Cutaneous and Peripheral T-Cell Lymphomas |
Study Start Date : | January 2006 |
Actual Primary Completion Date : | July 2009 |
Actual Study Completion Date : | July 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: Arm A
PXD101 1000 mg/m2 once daily for 5 days every 21 days
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Drug: belinostat
Other Name: PXD101 |
Experimental: Arm B
PXD101 1000 mg/m2 once daily for 5 days every 21 days
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Drug: belinostat
Other Name: PXD101 |
- Objective Response Rate in Patients With Recurrent or Refractory Cutaneous T-cell Lymphoma (CTCL) [ Time Frame: throughout the study, or for a maximum of 2 years ]Tumor response was assessed using Cheson (Cheson 2007) and SWAT criteria. The SWAT score represents the product of the percentage total body surface area (TBSA) involvement of each lesion type (patch, plaque, and tumor or ulceration), multiplied by a weighting factor.
- Objective Response Rate in Patients With Recurrent or Refractory Peripheral T-cell Lymphoma (PTCL)) [ Time Frame: throughout the study, or for a maximum of 2 years ]Tumor response was assessed using the revised criteria of Cheson (Cheson 2007).Tumor assessments were done using conventional radiographic methods, e.g. CT or CT/PET.
- Time to Progression [ Time Frame: throughout the study, or for a maximum of 2 years ]Time to progression was defined as the interval between the first date of treatment and the first notation of disease progression.
- Time to Response [ Time Frame: throughout the study, or for a maximum of 2 years ]Time to response was defined as the interval between the first date of treatment and the first notation of response.
- Duration of Response [ Time Frame: throughout the study, or for a maximum of 2 years ]Duration of response was defined as the time from first notation of response until the time of first notation of disease progression.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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).
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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).
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 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00274651
United States, California | |
Leland Stanford Junior University | |
Stanford, California, United States, 94305 | |
United States, Connecticut | |
Yale University School of Medicine | |
New Haven, Connecticut, United States, 06520 | |
United States, Kansas | |
Kansas City Cancer Center | |
Lenexa, Kansas, United States, 66214 | |
United States, Massachusetts | |
Dana Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 | |
Boston University Medical Center | |
Boston, Massachusetts, United States, 02118 | |
United States, New York | |
NYU Medical Center | |
New York, New York, United States, 10016 | |
United States, Ohio | |
Cleveland Clinic Foundation | |
Cleveland, Ohio, United States, 44195 | |
United States, Texas | |
MD Anderson Cancer Center | |
Houston, Texas, United States, 77030 | |
France | |
Hopitaux du Haut Leveque | |
Pessac, France, 33604 | |
Hospital Purpan | |
Toulouse, France, 31059 | |
Germany | |
Universitatsklinikum Essen | |
Essen, Germany, 45147 | |
Israel | |
Hadassah University Hospital Ein Kerem | |
Jerusalem, Israel, 91120 | |
Rabin Medical Center | |
Petach Tikva, Israel, 49100 | |
Thailand | |
Songklanagarind Hospital, Prince of Songkla University | |
Hat Yai, Thailand, 90110 | |
King Chulalongkorn Memorial Hospital | |
Patumwan, Thailand, 10330 |
Study Director: | e-mail contact via enquiries@topotarget.com | Onxeo |
Responsible Party: | Onxeo |
ClinicalTrials.gov Identifier: | NCT00274651 |
Other Study ID Numbers: |
PXD101-CLN-6 |
First Posted: | January 11, 2006 Key Record Dates |
Results First Posted: | October 27, 2014 |
Last Update Posted: | July 28, 2015 |
Last Verified: | July 2015 |
CTCL PTCL lymphoma Non-Hodgkin's Lymphoma |
Cutaneous T-Cell Lymphomas (CTCL) Peripheral T-Cell Lymphomas (PTCL) Other Types of Non-Hodgkin's Lymphoma belinostat |
Lymphoma Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoma, T-Cell, Peripheral Lymphoma, T-Cell, Cutaneous Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders |
Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Belinostat Antineoplastic Agents Histone Deacetylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |