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Recurrent Adult Burkitt LymphomaPhase 2NCT00303953

PXD101 in Treating Patients With Relapsed or Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma

A Phase 2 study testing belinostat in people with Recurrent Adult Burkitt Lymphoma and Recurrent Adult Diffuse Large Cell Lymphoma, run by National Cancer Institute (NCI) at 123 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This phase II trial is studying how well PXD101 works in treating patients with relapsed or refractory aggressive B-cell non-Hodgkin's lymphoma. PXD101 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
belinostat
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
123 sitesUnited States
Study dates
Jan 2006to Aug 2010
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 44Show fewer
  • Transformed NHL allowed
  • Not eligible for stem cell transplantation (for patients registered to study at first relapse)
  • 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

Who cannot join

None listed.

Trial locations and contacts

123 sites in 1 country.

123 sites in 1 country

United States123 sites

  • American Fork Hospital

    American Fork, Utah, 84003

  • Baton Rouge General Medical Center

    Baton Rouge, Louisiana, 70806

  • Mary Bird Perkins Cancer Center

    Baton Rouge, Louisiana, 70809

  • Saint Francis Hospital and Health Centers

    Beech Grove, Indiana, 46107

  • PeaceHealth Saint Joseph Medical Center

    Bellingham, Washington, 98225

  • Montana Cancer Consortium CCOP

    Billings, Montana, 59101

  • Northern Rockies Radiation Oncology Center

    Billings, Montana, 59101

  • Saint Vincent Healthcare

    Billings, Montana, 59101

  • Hematology-Oncology Centers of the Northern Rockies PC

    Billings, Montana, 59102

  • Billings Clinic

    Billings, Montana, 59107-7000

  • Deaconess Medical Center

    Billings, Montana, 59107

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • Bozeman Deaconess Cancer Center

    Bozeman, Montana, 59715

  • Bozeman Deaconess Hospital

    Bozeman, Montana, 59715

  • Internal Medicine of Bozeman

    Bozeman, Montana, 59715

  • Harrison HealthPartners Hematology and Oncology-Bremerton

    Bremerton, Washington, 98310

  • Saint James Community Hospital and Cancer Treatment Center

    Butte, Montana, 59701

  • East Bay Radiation Oncology Center

    Castro Valley, California, 94546

  • Eden Hospital Medical Center

    Castro Valley, California, 94546

  • Valley Medical Oncology Consultants-Castro Valley

    Castro Valley, California, 94546

  • Sandra L Maxwell Cancer Center

    Cedar City, Utah, 84720

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • Grandview Hospital

    Dayton, Ohio, 45405

  • Good Samaritan Hospital - Dayton

    Dayton, Ohio, 45406

  • Miami Valley Hospital

    Dayton, Ohio, 45409

  • Samaritan North Health Center

    Dayton, Ohio, 45415

  • Dayton CCOP

    Dayton, Ohio, 45420

  • Veteran Affairs Medical Center

    Dayton, Ohio, 45428

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Advocate Sherman Hospital

    Elgin, Illinois, 60123

  • Blanchard Valley Hospital

    Findlay, Ohio, 45840

  • McLeod Regional Medical Center

    Florence, South Carolina, 29506

  • Brooke Army Medical Center

    Fort Sam Houston, Texas, 78234

  • Atrium Medical Center-Middletown Regional Hospital

    Franklin, Ohio, 45005-1066

  • Valley Medical Oncology Consultants-Fremont

    Fremont, California, 94538

  • Wayne Radiation Oncology

    Goldsboro, North Carolina, 27534

  • Berdeaux, Donald MD (UIA Investigator)

    Great Falls, Montana, 59405

  • Great Falls Clinic

    Great Falls, Montana, 59405

  • Marin General Hospital

    Greenbrae, California, 94904

  • Northern Montana Hospital

    Havre, Montana, 59501

  • Saint Rose Hospital

    Hayward, California, 94545

  • Saint Peter's Community Hospital

    Helena, Montana, 59601

  • Centerpoint Medical Center LLC

    Independence, Missouri, 64057

  • NEA Baptist Memorial Hospital

    Jonesboro, Arkansas, 72401

  • Glacier Oncology PLLC

    Kalispell, Montana, 59901

  • Kalispell Medical Oncology

    Kalispell, Montana, 59901

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • Providence Medical Center

    Kansas City, Kansas, 66112

  • Truman Medical Center

    Kansas City, Missouri, 64108

  • Saint Luke's Cancer Institute

    Kansas City, Missouri, 64111

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111

  • Radiation Oncology Practice Corporation South

    Kansas City, Missouri, 64114

  • Saint Joseph Health Center

    Kansas City, Missouri, 64114

  • North Kansas City Hospital

    Kansas City, Missouri, 64116

  • Research Medical Center

    Kansas City, Missouri, 64132

  • Radiation Oncology Practice Corporation - North

    Kansas City, Missouri, 64154

  • Columbia Basin Hematology and Oncology PLLC

    Kennewick, Washington, 99336

  • Kettering Medical Center

    Kettering, Ohio, 45429

  • Wilford Hall Medical Center

    Lackland Air Force Base, Texas, 78236

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044

  • Cancer Centers of Central Florida PA

    Leesburg, Florida, 34788

  • Liberty Hospital

    Liberty, Missouri, 64068

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Logan Regional Hospital

    Logan, Utah, 84321

  • DeSoto Regional Health System

    Mansfield, Louisiana, 71052

  • Contra Costa Regional Medical Center

    Martinez, California, 94553-3156

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Community Medical Hospital

    Missoula, Montana, 59801

  • Montana Cancer Specialists

    Missoula, Montana, 59802

  • Saint Patrick Hospital - Community Hospital

    Missoula, Montana, 59802

  • Guardian Oncology and Center for Wellness

    Missoula, Montana, 59804

  • Providence Hospital

    Mobile, Alabama, 36608

  • Louisiana State University Sciences Center- Monroe

    Monroe, Louisiana, 71210

  • Skagit Valley Hospital

    Mount Vernon, Washington, 98274

  • Cottonwood Hospital Medical Center

    Murray, Utah, 84107

  • Intermountain Medical Center

    Murray, Utah, 84157

  • Interim LSU Public Hospital

    New Orleans, Louisiana, 70112

  • Louisiana State University Health Science Center

    New Orleans, Louisiana, 70112

  • Highland General Hospital

    Oakland, California, 94602

  • Alta Bates Summit Medical Center - Summit Campus

    Oakland, California, 94609

  • Bay Area Breast Surgeons Inc

    Oakland, California, 94609

  • Bay Area Tumor Institute CCOP

    Oakland, California, 94609

  • Larry G Strieff MD Medical Corporation

    Oakland, California, 94609

  • Tom K Lee Inc

    Oakland, California, 94609

  • McKay-Dee Hospital Center

    Ogden, Utah, 84403

  • Menorah Medical Center

    Overland Park, Kansas, 66209

  • Radiation Oncology Practice Corporation Southwest

    Overland Park, Kansas, 66210

  • Valley Care Health System - Pleasanton

    Pleasanton, California, 94588

  • Valley Medical Oncology Consultants

    Pleasanton, California, 94588

  • Utah Valley Regional Medical Center

    Provo, Utah, 84604-3337

  • Reid Hospital and Health Care Services

    Richmond, Indiana, 47374

  • Highland Hospital

    Rochester, New York, 14620

  • Heartland Regional Medical Center

    Saint Joseph, Missouri, 64506

  • Salina Regional Health Center

    Salina, Kansas, 67401

  • Intermountain Health Care

    Salt Lake City, Utah, 84103

  • Utah Cancer Specialists-Salt Lake City

    Salt Lake City, Utah, 84106

  • LDS Hospital

    Salt Lake City, Utah, 84143

  • Southwest Oncology Group

    San Antonio, Texas, 78245

  • Doctors Medical Center- JC Robinson Regional Cancer Center

    San Pablo, California, 94806

  • Harborview Medical Center

    Seattle, Washington, 98104

  • Minor and James Medical PLLC

    Seattle, Washington, 98104

  • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

    Seattle, Washington, 98109

  • Group Health Cooperative-Seattle

    Seattle, Washington, 98112

  • Swedish Medical Center-First Hill

    Seattle, Washington, 98122-4307

  • The Polyclinic

    Seattle, Washington, 98122

  • University of Washington Medical Center

    Seattle, Washington, 98195

  • United General Hospital

    Sedro-Woolley, Washington, 98284

  • Shawnee Mission Medical Center

    Shawnee Mission, Kansas, 66204

  • Welch Cancer Center

    Sheridan, Wyoming, 82801

  • Highland Clinic

    Shreveport, Louisiana, 71105

  • Louisiana State University Health Sciences Center Shreveport

    Shreveport, Louisiana, 71130

  • Cancer Care Northwest - Spokane South

    Spokane, Washington, 99202

  • Memorial Medical Center

    Springfield, Illinois, 62781-0001

  • Dixie Medical Center Regional Cancer Center

    St. George, Utah, 84770

  • Madigan Army Medical Center

    Tacoma, Washington, 98431

  • Upper Valley Medical Center

    Troy, Ohio, 45373

  • University of Arizona Health Sciences Center

    Tucson, Arizona, 85724

  • Sutter Solano Medical Center

    Vallejo, California, 94589

  • Wenatchee Valley Medical Center

    Wenatchee, Washington, 98801

  • Clinton Memorial Hospital

    Wilmington, Ohio, 45177

  • Wilson Medical Center

    Wilson, North Carolina, 27893

  • Greene Memorial Hospital

    Xenia, Ohio, 45385

Other trials in United States

About this study

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

This phase II trial is studying how well PXD101 works in treating patients with relapsed or refractory aggressive B-cell non-Hodgkin's lymphoma. PXD101 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer.

Read the detailed description

PRIMARY OBJECTIVES:

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

SECONDARY OBJECTIVES:

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

TERTIARY OBJECTIVES:

  1. 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 years.

Being tested
belinostat
Medical subject headings
Burkitt Lymphoma, Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • belinostatDrug

    Also called PXD101

    Given IV

Study groups in NCT00303953
Study groupRoleWhat they receive
Arm IExperimentalPatients will receive an infusion of PXD101 once a day for 5 days. Treatment may repeat every 3 weeks for up to 2 years. Some patients will also undergo core biopsy and blood collection for laboratory studies before and after treatment. After finishing treatment, patients will be evaluated every 3-6 months for up to 3 years.
Receives: Drug: belinostat

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

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

Secondary outcomes (2)

  1. Overall Survival

    Measured from time of registration to death, or last contact date

    Measured: assessed every 3 months for 3 years

  2. Progression-free Survival

    Measured from date of registration to time of first documentation of progression or death, or last contact date. Progression is defined as a 50% increase in sum of products of greatest diameters (SPD) of target measurable lesions over the smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline; appearance of a new lesion/site; unequivocal progression of non-measurable disease in the opinion of the treating physician; death due to disease without prior documentation of progression.

    Measured: assessed at week 8, then every 3 months for 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2006 (estimated)
  2. Study startJan 2006
  3. Primary completionJan 2010
  4. Study completionAug 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00303953
Sponsor's protocol ID
NCI-2009-01096
Other IDs
NCI-2009-01096, CDR0000462614, S0520, S0520, U10CA032102
Status last verified
Apr 2013
First submitted
15 Mar 2006
Last updated
12 May 2014

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing belinostat in people with Recurrent Adult Burkitt Lymphoma and Recurrent Adult Diffuse Large Cell Lymphoma, run by National Cancer Institute (NCI) at 123 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 44 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 123 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assess Number of Patients Who Achieve Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR) (time frame: assessed at week 8, and every 3 months for 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00303953.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2014.

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