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


Phase 2
18 Years
N/A
Not Enrolling
Both
Recurrent Adult Burkitt Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma

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Trial Information

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


PRIMARY OBJECTIVES:

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

SECONDARY OBJECTIVES:

I. 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:

I. 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.


Inclusion Criteria:



- 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

- 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Description:

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.

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

Steven Bernstein

Investigator Role:

Principal Investigator

Investigator Affiliation:

Southwest Oncology Group

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2009-01096

NCT ID:

NCT00303953

Start Date:

January 2006

Completion Date:

Related Keywords:

  • Recurrent Adult Burkitt Lymphoma
  • Recurrent Adult Diffuse Large Cell Lymphoma
  • Burkitt Lymphoma
  • Lymphoma
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell

Name

Location

Louisiana State UniversityNew Orleans, Louisiana  70112-2282
University of Washington Medical CenterSeattle, Washington  98195-6043
Loyola University Medical CenterMaywood, Illinois  60153
Henry Ford HospitalDetroit, Michigan  48202
Mary Bird Perkins Cancer CenterBaton Rouge, Louisiana  70809
LDS HospitalSalt Lake City, Utah  84143
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Boston Medical CenterBoston, Massachusetts  02118
Brooke Army Medical CenterFort Sam Houston, Texas  78234-6200
Madigan Army Medical CenterTacoma, Washington  98431-5048
Group Health CooperativeSeattle, Washington  98112
Great Falls ClinicGreat Falls, Montana  59405
Wilford Hall Medical CenterLackland Air Force Base, Texas  78236-5300
Fred Hutchinson Cancer Research Center/University of Washington Cancer ConsortiumSeattle, Washington  98109
Northern Rockies Radiation Oncology CenterBillings, Montana  59101
Bozeman Deaconess HospitalBozeman, Montana  59715
Kalispell Medical OncologyKalispell, Montana  59901
Kalispell Regional Medical CenterKalispell, Montana  59901
American Fork HospitalAmerican Fork, Utah  84003
Logan Regional HospitalLogan, Utah  84321
Cottonwood Hospital Medical CenterMurray, Utah  84107
McKay-Dee Hospital CenterOgden, Utah  84403
Harborview Medical CenterSeattle, Washington  98104
Cancer Care Northwest - Spokane SouthSpokane, Washington  99202
Welch Cancer CenterSheridan, Wyoming  82801
Saint Rose HospitalHayward, California  94545
Alta Bates Summit Medical Center - Summit CampusOakland, California  94609
Sutter Solano Medical CenterVallejo, California  94589
Salina Regional Health CenterSalina, Kansas  67401
Wayne Radiation OncologyGoldsboro, North Carolina  27534
Wilson Medical CenterWilson, North Carolina  27893-3428
Grandview HospitalDayton, Ohio  45405
Highland General HospitalOakland, California  94602
Miami Valley HospitalDayton, Ohio  45409
Lawrence Memorial HospitalLawrence, Kansas  66044
Menorah Medical CenterOverland Park, Kansas  66209
Shawnee Mission Medical CenterShawnee Mission, Kansas  66204
North Kansas City HospitalKansas City, Missouri  64116
Research Medical CenterKansas City, Missouri  64132
Heartland Regional Medical CenterSaint Joseph, Missouri  64506
Bozeman Deaconess Cancer CenterBozeman, Montana  59715
Northern Montana HospitalHavre, Montana  59501
Clinton Memorial HospitalWilmington, Ohio  45177
Wenatchee Valley Medical CenterWenatchee, Washington  98801-2028
Baton Rouge General Medical CenterBaton Rouge, Louisiana  70821-2511
Greene Memorial HospitalXenia, Ohio  45385
Sherman HospitalElgin, Illinois  60120-2198
Memorial Medical CenterSpringfield, Illinois  62781
McLeod Regional Medical CenterFlorence, South Carolina  29501
Guardian Oncology and Center for WellnessMissoula, Montana  59804
Providence HospitalMobile, Alabama  36608
Providence Medical CenterKansas City, Kansas  66112
Independence Regional Health CenterIndependence, Missouri  64050
East Bay Radiation Oncology CenterCastro Valley, California  94546
Contra Costa Regional Medical CenterMartinez, California  94553-3156
Larry G Strieff MD Medical CorporationOakland, California  94609
University of Arizona Health Sciences CenterTucson, Arizona  85724
Montana Cancer Consortium CCOPBillings, Montana  59101
Decatur Memorial HospitalDecatur, Illinois  62526
Louisiana State University Health Science CenterNew Orleans, Louisiana  70112
Montana Cancer SpecialistsMissoula, Montana  59807-7877
University of CincinnatiCincinnati, Ohio  45267-0502
Valley Medical Oncology Consultants-Castro ValleyCastro Valley, California  94546
Eden Hospital Medical CenterCastro Valley, California  94546
Valley Medical Oncology Consultants-FremontFremont, California  94538
Bay Area Breast Surgeons IncOakland, California  94609
Bay Area Tumor Institution CCOPOakland, California  94609
Tom K Lee IncOakland, California  94609
Valley Medical Oncology ConsultantsPleasanton, California  94588
Valley Care Health System - PleasantonPleasanton, California  94588
Doctors Medical Center- JC Robinson Regional Cancer CenterSan Pablo, California  94806
Cancer Centers of Central Florida PALeesburg, Florida  34788
Saint Francis Hospital and Health CentersBeech Grove, Indiana  46107
Reid Hospital and Health Care ServicesRichmond, Indiana  47374
Radiation Oncology Practice Corporation SouthwestOverland Park, Kansas  66210
DeSoto Regional Health SystemMansfield, Louisiana  71052
Louisiana State University Sciences Center- MonroeMonroe, Louisiana  71210
Medical Center of LouisianaNew Orleans, Louisiana  70112
Highland ClinicShreveport, Louisiana  71105
Radiation Oncology Practice Corporation - NorthKansas City, Missouri  64154
Saint Luke's Cancer InstituteKansas City, Missouri  64111
Radiation Oncology Practice Corporation SouthKansas City, Missouri  64114
Saint Luke's Hospital of Kansas CityKansas City, Missouri  64111
Saint Joseph Health CenterKansas City, Missouri  64114
Liberty Radiation Oncology ClinicKansas City, Missouri  64116
Truman Medical CenterKansas City, Missouri  64108
Hematology-Oncology Centers of the Northern Rockies PCBillings, Montana  59101
Saint Vincent HealthcareBillings, Montana  59101
Deaconess Medical CenterBillings, Montana  59107
Billings ClinicBillings, Montana  59107-7000
Internal Medicine of BozemanBozeman, Montana  59715
Saint James Community Hospital and Cancer Treatment CenterButte, Montana  59701
Berdeaux, Donald MD (UIA Investigator)Great Falls, Montana  59405
Saint Peter's Community HospitalHelena, Montana  59601
Glacier Oncology PLLCKalispell, Montana  59901
Community Medical HospitalMissoula, Montana  59801
Saint Patrick Hospital - Community HospitalMissoula, Montana  59802
Highland HospitalRochester, New York  14620
Good Samaritan Hospital - DaytonDayton, Ohio  45406
Dayton CCOPDayton, Ohio  45429
Samaritan North Health CenterDayton, Ohio  45415
Veteran Affairs Medical CenterDayton, Ohio  45428
Blanchard Valley HospitalFindlay, Ohio  45840
Atrium Medical Center-Middletown Regional HospitalFranklin, Ohio  45005-1066
Kettering Medical CenterKettering, Ohio  45429
Upper Valley Medical CenterTroy, Ohio  45373
Harrison Bremerton Hematology and OncologyBremerton, Washington  98310
Columbia Basin Hematology and Oncology PLLCKennewick, Washington  99336
Minor and James Medical PLLCSeattle, Washington  98104
The PolyclinicSeattle, Washington  98122
Swedish Medical Center-First HillSeattle, Washington  98122-4307
Marin General HospitalGreenbrae, California  94904
Sandra L Maxwell Cancer CenterCedar City, Utah  84720
Intermountain Medical CenterMurray, Utah  84157
Utah Valley Regional Medical CenterProvo, Utah  84603
Dixie Medical Center Regional Cancer CenterSaint George, Utah  84770
Intermountain Health CareSalt Lake City, Utah  84103
Utah Cancer Specialists-Salt Lake CitySalt Lake City, Utah  84106
Skagit Valley HospitalMt. Vernon, Washington  98273
United General HospitalSedro-Woolley, Washington  98284
Southwest Oncology GroupSan Antonio, Texas  78245
PeaceHealth Saint Joseph Medical CenterBellingham, Washington  98225
NEA Baptist Memorial HospitalJonesboro, Arkansas  72401