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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 University New Orleans, Louisiana  70112-2282
University of Washington Medical Center Seattle, Washington  98195-6043
Loyola University Medical Center Maywood, Illinois  60153
Henry Ford Hospital Detroit, Michigan  48202
Mary Bird Perkins Cancer Center Baton Rouge, Louisiana  70809
LDS Hospital Salt Lake City, Utah  84143
University of Arkansas for Medical Sciences Little Rock, Arkansas  72205
Boston Medical Center Boston, Massachusetts  02118
Brooke Army Medical Center Fort Sam Houston, Texas  78234-6200
Madigan Army Medical Center Tacoma, Washington  98431-5048
Group Health Cooperative Seattle, Washington  98112
Great Falls Clinic Great Falls, Montana  59405
Wilford Hall Medical Center Lackland Air Force Base, Texas  78236-5300
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium Seattle, Washington  98109
Northern Rockies Radiation Oncology Center Billings, Montana  59101
Bozeman Deaconess Hospital Bozeman, Montana  59715
Kalispell Medical Oncology Kalispell, Montana  59901
Kalispell Regional Medical Center Kalispell, Montana  59901
American Fork Hospital American Fork, Utah  84003
Logan Regional Hospital Logan, Utah  84321
Cottonwood Hospital Medical Center Murray, Utah  84107
McKay-Dee Hospital Center Ogden, Utah  84403
Harborview Medical Center Seattle, Washington  98104
Cancer Care Northwest - Spokane South Spokane, Washington  99202
Welch Cancer Center Sheridan, Wyoming  82801
Saint Rose Hospital Hayward, California  94545
Alta Bates Summit Medical Center - Summit Campus Oakland, California  94609
Sutter Solano Medical Center Vallejo, California  94589
Salina Regional Health Center Salina, Kansas  67401
Wayne Radiation Oncology Goldsboro, North Carolina  27534
Wilson Medical Center Wilson, North Carolina  27893-3428
Grandview Hospital Dayton, Ohio  45405
Highland General Hospital Oakland, California  94602
Miami Valley Hospital Dayton, Ohio  45409
Lawrence Memorial Hospital Lawrence, Kansas  66044
Menorah Medical Center Overland Park, Kansas  66209
Shawnee Mission Medical Center Shawnee Mission, Kansas  66204
North Kansas City Hospital Kansas City, Missouri  64116
Research Medical Center Kansas City, Missouri  64132
Heartland Regional Medical Center Saint Joseph, Missouri  64506
Bozeman Deaconess Cancer Center Bozeman, Montana  59715
Northern Montana Hospital Havre, Montana  59501
Clinton Memorial Hospital Wilmington, Ohio  45177
Wenatchee Valley Medical Center Wenatchee, Washington  98801-2028
Baton Rouge General Medical Center Baton Rouge, Louisiana  70821-2511
Greene Memorial Hospital Xenia, Ohio  45385
Sherman Hospital Elgin, Illinois  60120-2198
Memorial Medical Center Springfield, Illinois  62781
McLeod Regional Medical Center Florence, South Carolina  29501
Guardian Oncology and Center for Wellness Missoula, Montana  59804
Providence Hospital Mobile, Alabama  36608
Providence Medical Center Kansas City, Kansas  66112
Independence Regional Health Center Independence, Missouri  64050
East Bay Radiation Oncology Center Castro Valley, California  94546
Contra Costa Regional Medical Center Martinez, California  94553-3156
Larry G Strieff MD Medical Corporation Oakland, California  94609
University of Arizona Health Sciences Center Tucson, Arizona  85724
Montana Cancer Consortium CCOP Billings, Montana  59101
Decatur Memorial Hospital Decatur, Illinois  62526
Louisiana State University Health Science Center New Orleans, Louisiana  70112
Montana Cancer Specialists Missoula, Montana  59807-7877
University of Cincinnati Cincinnati, Ohio  45267-0502
Valley Medical Oncology Consultants-Castro Valley Castro Valley, California  94546
Eden Hospital Medical Center Castro Valley, California  94546
Valley Medical Oncology Consultants-Fremont Fremont, California  94538
Bay Area Breast Surgeons Inc Oakland, California  94609
Bay Area Tumor Institution CCOP Oakland, California  94609
Tom K Lee Inc Oakland, California  94609
Valley Medical Oncology Consultants Pleasanton, California  94588
Valley Care Health System - Pleasanton Pleasanton, California  94588
Doctors Medical Center- JC Robinson Regional Cancer Center San Pablo, California  94806
Cancer Centers of Central Florida PA Leesburg, Florida  34788
Saint Francis Hospital and Health Centers Beech Grove, Indiana  46107
Reid Hospital and Health Care Services Richmond, Indiana  47374
Radiation Oncology Practice Corporation Southwest Overland Park, Kansas  66210
DeSoto Regional Health System Mansfield, Louisiana  71052
Louisiana State University Sciences Center- Monroe Monroe, Louisiana  71210
Medical Center of Louisiana New Orleans, Louisiana  70112
Highland Clinic Shreveport, Louisiana  71105
Radiation Oncology Practice Corporation - North Kansas City, Missouri  64154
Saint Luke's Cancer Institute Kansas City, Missouri  64111
Radiation Oncology Practice Corporation South Kansas City, Missouri  64114
Saint Luke's Hospital of Kansas City Kansas City, Missouri  64111
Saint Joseph Health Center Kansas City, Missouri  64114
Liberty Radiation Oncology Clinic Kansas City, Missouri  64116
Truman Medical Center Kansas City, Missouri  64108
Hematology-Oncology Centers of the Northern Rockies PC Billings, Montana  59101
Saint Vincent Healthcare Billings, Montana  59101
Deaconess Medical Center Billings, Montana  59107
Billings Clinic Billings, Montana  59107-7000
Internal Medicine of Bozeman Bozeman, Montana  59715
Saint James Community Hospital and Cancer Treatment Center Butte, Montana  59701
Berdeaux, Donald MD (UIA Investigator) Great Falls, Montana  59405
Saint Peter's Community Hospital Helena, Montana  59601
Glacier Oncology PLLC Kalispell, Montana  59901
Community Medical Hospital Missoula, Montana  59801
Saint Patrick Hospital - Community Hospital Missoula, Montana  59802
Highland Hospital Rochester, New York  14620
Good Samaritan Hospital - Dayton Dayton, Ohio  45406
Dayton CCOP Dayton, Ohio  45429
Samaritan North Health Center Dayton, Ohio  45415
Veteran Affairs Medical Center Dayton, Ohio  45428
Blanchard Valley Hospital Findlay, Ohio  45840
Atrium Medical Center-Middletown Regional Hospital Franklin, Ohio  45005-1066
Kettering Medical Center Kettering, Ohio  45429
Upper Valley Medical Center Troy, Ohio  45373
Harrison Bremerton Hematology and Oncology Bremerton, Washington  98310
Columbia Basin Hematology and Oncology PLLC Kennewick, Washington  99336
Minor and James Medical PLLC Seattle, Washington  98104
The Polyclinic Seattle, Washington  98122
Swedish Medical Center-First Hill Seattle, Washington  98122-4307
Marin General Hospital Greenbrae, California  94904
Sandra L Maxwell Cancer Center Cedar City, Utah  84720
Intermountain Medical Center Murray, Utah  84157
Utah Valley Regional Medical Center Provo, Utah  84603
Dixie Medical Center Regional Cancer Center Saint George, Utah  84770
Intermountain Health Care Salt Lake City, Utah  84103
Utah Cancer Specialists-Salt Lake City Salt Lake City, Utah  84106
Skagit Valley Hospital Mt. Vernon, Washington  98273
United General Hospital Sedro-Woolley, Washington  98284
Southwest Oncology Group San Antonio, Texas  78245
PeaceHealth Saint Joseph Medical Center Bellingham, Washington  98225
NEA Baptist Memorial Hospital Jonesboro, Arkansas  72401