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NCT00274651 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
TERMINATED
Registry last update
2015-07-28

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Objective Response Rate in Patients With Recurrent or Refractory Cutaneous T-cell Lymphoma (CTCL)

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outcome · POSTED

Objective Response Rate in Patients With Recurrent or Refractory Peripheral T-cell Lymphoma (PTCL))

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outcome · POSTED

Time to Progression

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outcome · POSTED

Time to Response

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outcome · POSTED

Duration of Response

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outcome · POSTED

Objective Response Rate in Patients With Recurrent or Refractory Cutaneous T-cell Lymphoma (CTCL)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
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 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.
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    PXD101 1000 mg/m2 once daily for 5 days every 21 days
    intervention Names
    1. Drug: belinostat
    label
    Arm A
    type
    EXPERIMENTAL
  2. description
    PXD101 1000 mg/m2 once daily for 5 days every 21 days
    intervention Names
    1. Drug: belinostat
    label
    Arm B
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Arm A
    2. Arm B
    name
    belinostat
    other Names
    1. PXD101
    type
    DRUG
Study design
allocation
NON_RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
53
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    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.
    measure
    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
  2. description
    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.
    measure
    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
secondary Outcomes
  1. description
    Time to progression was defined as the interval between the first date of treatment and the first notation of disease progression.
    measure
    Time to Progression
    time Frame
    throughout the study, or for a maximum of 2 years
  2. description
    Time to response was defined as the interval between the first date of treatment and the first notation of response.
    measure
    Time to Response
    time Frame
    throughout the study, or for a maximum of 2 years
  3. description
    Duration of response was defined as the time from first notation of response until the time of first notation of disease progression.
    measure
    Duration of Response
    time Frame
    throughout the study, or for a maximum of 2 years
Full study description
brief Summary
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.
Source references
references
  1. citation
    Foss F, Advani R, Duvic M, Hymes KB, Intragumtornchai T, Lekhakula A, Shpilberg O, Lerner A, Belt RJ, Jacobsen ED, Laurent G, Ben-Yehuda D, Beylot-Barry M, Hillen U, Knoblauch P, Bhat G, Chawla S, Allen LF, Pohlman B. A Phase II trial of Belinostat (PXD101) in patients with relapsed or refractory peripheral or cutaneous T-cell lymphoma. Br J Haematol. 2015 Mar;168(6):811-9. doi: 10.1111/bjh.13222. Epub 2014 Nov 17.
    pmid
    25404094
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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        exact text
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      offset unit
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      query cond
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      query disease state id
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      source file
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      source file sha256
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      source kind
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      source record id
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      source string sha256
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    Preserved source evidence · Not medical advice