Trial record 1 of 1 for:    SWOG S0806
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Vorinostat, Rituximab, and Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II, Stage III, or Stage IV Diffuse Large B-Cell Lymphoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00972478
First received: September 4, 2009
Last updated: August 22, 2014
Last verified: March 2014
  Purpose

This phase I/II trial is studying the side effects and best dose of vorinostat when given together with rituximab and combination chemotherapy and to see how well it works in treating patients with newly diagnosed stage II, stage III, or stage IV diffuse large B-cell lymphoma. Vorinostat 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. Monoclonal antibodies, such as rituximab, can block cancer cell growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cell-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving vorinostat together with rituximab and combination chemotherapy may kill more cancer cells.


Condition Intervention Phase
Contiguous Stage II Adult Diffuse Large Cell Lymphoma
Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma
Stage III Adult Diffuse Large Cell Lymphoma
Stage IV Adult Diffuse Large Cell Lymphoma
Drug: vorinostat
Biological: rituximab
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: vincristine sulfate
Drug: prednisone
Other: laboratory biomarker analysis
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II Trial of Vorinostat (SAHA) (NSC-701852) in Combination With Rituximab-CHOP in Patients With Newly Diagnosed Advanced Stage Diffuse Large B-Cell Lymphoma (DLBCL)

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Safe dose of vorinostat to be used in combination with R-CHOP assessed by CTCAE Version 4.0 (phase I) [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]
  • Progression-free survival (phase II) [ Time Frame: From date of registration to date of first observation of progressive disease or death due to any cause, up to 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity of vorinostat-R-CHOP in patients with newly diagnosed DLBCL [ Time Frame: Up to week 26 ] [ Designated as safety issue: Yes ]
    Graded using the National Cancer Institute (NCI) CTCAE version 4.0.

  • Overall survival (phase II) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Response rate (complete response [CR]+partial response [PR]) (phase II) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Histone acetylation [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Correlative studies will explore the relationship between baseline acetylation and PFS.

  • T-cell subsets [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Correlative studies will explore the relationship between T-cell subsets and PFS.


Estimated Enrollment: 95
Study Start Date: November 2010
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (combination chemotherapy)
Patients receive vorinostat PO once daily on days 1-5 or 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
Drug: vorinostat
Given PO
Other Names:
  • L-001079038
  • SAHA
  • suberoylanilide hydroxamic acid
  • Zolinza
Biological: rituximab
Given IV
Other Names:
  • IDEC-C2B8
  • IDEC-C2B8 monoclonal antibody
  • Mabthera
  • MOAB IDEC-C2B8
  • Rituxan
Drug: cyclophosphamide
Given IV
Other Names:
  • CPM
  • CTX
  • Cytoxan
  • Endoxan
  • Endoxana
Drug: doxorubicin hydrochloride
Given IV
Other Names:
  • ADM
  • ADR
  • Adria
Drug: vincristine sulfate
Given IV
Other Names:
  • leurocristine sulfate
  • VCR
  • Vincasar PFS
Drug: prednisone
Given IV
Other Names:
  • DeCortin
  • Deltra
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:

PRIMARY OBJECTIVES:

I. To find a safe dose of vorinostat to be used in combination with R-CHOP (rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone) (vorinostat-R-CHOP). (Phase I) II. To estimate the 2-year progression-free survival (PFS) rate in patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL) treated with vorinostat and R-CHOP therapy (vorinostat-R-CHOP). (Phase II) III. To estimate the response rate (complete and partial) and 2-year overall survival rate. (Phase II) IV. To evaluate the toxicity of vorinostat-R-CHOP in patients with newly diagnosed DLBCL. (Phase II) V. To assess whether pre-treatment acetylation status of histones, expression of major histocompatibility complex (MHC) class II genes, and/or percentage of cluster of differentiation (CD)8+ tumor infiltrating lymphocytes correlate with progression-free survival. (Phase II) VI. To explore whether treatment with vorinostat-R-CHOP increases histone acetylation, alters expression of MHC class II proteins, or alters percentage of T-cell subsets (CD8+, CD4+, forkhead box P3 [FOXP3]+) or infiltrating macrophages. (Phase II) VII. To explore whether histone acetylation status of tumor tissues correlates with MHC class II expression of peripheral blood B cells and lymphocyte subsets. (Phase II) VIII. To explore whether the change in systemic levels of immune cytokines with vorinostat-R-CHOP correlates with lymphoma symptoms, response, progression-free or overall survival. (Phase II)

OUTLINE: This is a phase I, dose escalation study of vorinostat followed by a phase II study.

Patients receive vorinostat orally (PO) once daily on days 1-5 or 1-9 (according to dose level), rituximab intravenously (IV), cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 6 months for 2 years, and then annually for 3 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have biopsy proven, newly diagnosed DLBCL with stage II bulky, stage III or stage IV disease, with an International Prognostic Index (IPI) or revised (R)-IPI score greater than 0; a report providing confirmation of CD20 expression must be submitted
  • Adequate sections from the original diagnostic specimen must be available for submission for review by the Southwest Oncology Group (SWOG) Lymphoma Pathology Laboratory; an adequate biopsy requires sufficient tissue to establish the architecture and World Health Organization (WHO) histologic subtype with certainty; fine needle aspiration or cytology is not adequate
  • Patients must be offered the opportunity to consent to the correlative science studies; patients are encouraged to submit specimens for correlative studies; however, specimen submission is not a requirement for participation in the study
  • Patients must have measurable disease; measurable disease must be determined by computed tomography (CT) scan of chest, abdomen and pelvis performed within 28 days prior to registration; positron emission tomography (PET)/CT may be substituted for CT scan only if CT scan is of diagnostic quality and is contrast enhanced
  • Patients must have a unilateral bone marrow aspirate and biopsy for staging performed within 42 days prior to registration
  • Patients must not have clinical evidence of central nervous system involvement by lymphoma; any laboratory or radiographic tests performed within 42 days prior to registration to assess central nervous system (CNS) involvement must be negative
  • Patients must not have received prior chemotherapy, radiation, or antibody therapy for lymphoma; steroid pre-medication for IV contrast allergy is allowed
  • Patients must have Zubrod performance status of 0-2
  • Patients must have serum lactate dehydrogenase (LDH) measured within 28 days prior to registration
  • Absolute neutrophil count (ANC) > 1,000/mcL within 28 days prior to registration, unless due to bone marrow infiltration by lymphoma
  • Platelets > 100,000/mcL within 28 days prior to registration, unless due to bone marrow infiltration by lymphoma
  • Cardiac ejection fraction ≥ institutional lower limit of normal (ILLN) by multigated acquisition (MUGA) scan or 2-dimensional (2-D) echocardiogram (ECHO) with no significant abnormalities within 42 days prior to registration
  • Patients must not have received valproic acid (a histone deacetylase [HDAC] inhibitor) within 28 days prior to registration
  • Patients must have no known hypersensitivity to the components of treatment
  • Patients must be willing to discontinue taking any medications that are generally accepted to have a risk of causing Torsades de Pointes while on study
  • Patients known to be human immunodeficiency virus (HIV) positive are not eligible; existing therapeutic options are effective and study design does not support assessing the efficacy of treatment on those with HIV
  • No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years
  • Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method; a woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures
  • All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
  • At the time of patient registration, the treating institution's name and identification (ID) number must be provided to the Data Operations Center in Seattle in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered into the data base
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00972478

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Locations
United States, Alabama
Providence Hospital
Mobile, Alabama, United States, 36608
United States, Arizona
Arizona Cancer Center at UMC Orange Grove
Tucson, Arizona, United States, 85704
Arizona Cancer Center at University Medical Center North
Tucson, Arizona, United States, 85719
University of Arizona Health Sciences Center
Tucson, Arizona, United States, 85724
United States, Arkansas
Saint Edward Mercy Medical Center
Ft. Smith, Arkansas, United States, 72903
Fowler Family Center for Cancer Care
Jonesboro, Arkansas, United States, 72401
NEA Baptist Memorial Hospital
Jonesboro, Arkansas, United States, 72401
United States, California
Kaiser Permanente-Deer Valley Medical Center
Antioch, California, United States, 94531
City of Hope Medical Center
Duarte, California, United States, 91010
City of Hope
Duarte, California, United States, 91010
Kaiser Permanente, Fremont
Fremont, California, United States, 94538
Kaiser Permanente
Fresno, California, United States, 93720
University of Southern California/Norris Cancer Center
Los Angeles, California, United States, 90033
Kaiser Permanente-Modesto
Modesto, California, United States, 95356
Kaiser Permanente-Oakland
Oakland, California, United States, 94611
Kaiser Permanente-Redwood City
Redwood City, California, United States, 94063
Kaiser Permanente-Richmond
Richmond, California, United States, 94801
Kaiser Permanente-Roseville
Roseville, California, United States, 95661
Kaiser Permanente-South Sacramento
Sacramento, California, United States, 95823
Kaiser Permanente - Sacramento
Sacramento, California, United States, 95825
Kaiser Permanente-San Francisco
San Francisco, California, United States, 94115
Kaiser Permanente-Santa Teresa-San Jose
San Jose, California, United States, 95119
Kaiser Permanente San Leandro
San Leandro, California, United States, 94577
Kaiser Permanente-San Rafael
San Rafael, California, United States, 94903
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, United States, 95051
Kaiser Permanente-Santa Rosa
Santa Rosa, California, United States, 95403
Kaiser Permanente-South San Francisco
South San Francisco, California, United States, 94080
Kaiser Permanente-Stockton
Stockton, California, United States, 95210
Kaiser Permanente Medical Center-Vacaville
Vacaville, California, United States, 95688
Kaiser Permanente-Vallejo
Vallejo, California, United States, 94589
Kaiser Permanente-Walnut Creek
Walnut Creek, California, United States, 94596
United States, Colorado
Front Range Cancer Specialists
Fort Collins, Colorado, United States, 80528
Poudre Valley Hospital
Fort Collins, Colorado, United States, 80524
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06520
United States, Georgia
Memorial University Medical Center
Savannah, Georgia, United States, 31404
United States, Hawaii
Pali Momi Medical Center
Aiea, Hawaii, United States, 96701
Oncare Hawaii Inc-Pali Momi
Aiea, Hawaii, United States, 96701
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States, 96826
Kuakini Medical Center
Honolulu, Hawaii, United States, 96817
OnCare Hawaii-Liliha
Honolulu, Hawaii, United States, 96817-3169
Oncare Hawaii Inc-POB II
Honolulu, Hawaii, United States, 96813
Kaiser Permanente Moanalua Medical Center
Honolulu, Hawaii, United States, 96819
Oncare Hawaii Inc-Kuakini
Honolulu, Hawaii, United States, 96817
Queen's Medical Center
Honolulu, Hawaii, United States, 96813
Straub Clinic and Hospital
Honolulu, Hawaii, United States, 96813
Tripler Army Medical Center
Honolulu, Hawaii, United States, 96859
University of Hawaii
Honolulu, Hawaii, United States, 96813
Castle Medical Center
Kailua, Hawaii, United States, 96734
Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue, Hawaii, United States, 96766
United States, Illinois
Cadence Cancer Center at Delnor
Geneva, Illinois, United States, 60134
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Good Samaritan Regional Health Center
Mount Vernon, Illinois, United States, 62864
Cadence Cancer Center in Warrenville
Warrenville, Illinois, United States, 60555
United States, Indiana
Saint Francis Hospital and Health Centers
Beech Grove, Indiana, United States, 46107
Franciscan Saint Francis Health-Indianapolis
Indianapolis, Indiana, United States, 46237
Reid Hospital and Health Care Services
Richmond, Indiana, United States, 47374
United States, Kansas
Cancer Center of Kansas - Chanute
Chanute, Kansas, United States, 66720
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, United States, 67801
Cancer Center of Kansas - El Dorado
El Dorado, Kansas, United States, 67042
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, United States, 66701
Saint Rose Ambulatory and Surgery Center
Great Bend, Kansas, United States, 67530
Hays Medical Center
Hays, Kansas, United States, 67601
Promise Regional Medical Center-Hutchinson
Hutchinson, Kansas, United States, 65702
Cancer Center of Kansas-Independence
Independence, Kansas, United States, 67301
Providence Medical Center
Kansas City, Kansas, United States, 66112
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Cancer Center of Kansas-Kingman
Kingman, Kansas, United States, 67068
Lawrence Memorial Hospital
Lawrence, Kansas, United States, 66044
Cancer Center of Kansas-Liberal
Liberal, Kansas, United States, 67901
Cancer Center of Kansas - Newton
Newton, Kansas, United States, 67114
Saint Luke's South Hospital
Overland Park, Kansas, United States, 66213
Menorah Medical Center
Overland Park, Kansas, United States, 66209
Cancer Center of Kansas - Parsons
Parsons, Kansas, United States, 67357
Via Christi Hospital-Pittsburg
Pittsburg, Kansas, United States, 66762
Kansas City CCOP
Prairie Village, Kansas, United States, 66208
Cancer Center of Kansas - Pratt
Pratt, Kansas, United States, 67124
Cancer Center of Kansas - Salina
Salina, Kansas, United States, 67401
Salina Regional Health Center
Salina, Kansas, United States, 67401
Saint Francis Hospital and Medical Center - Topeka
Topeka, Kansas, United States, 66606
Cancer Center of Kansas - Wellington
Wellington, Kansas, United States, 67152
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, United States, 67208
Cancer Center of Kansas - Main Office
Wichita, Kansas, United States, 67214
Associates In Womens Health
Wichita, Kansas, United States, 67208
Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
Wichita CCOP
Wichita, Kansas, United States, 67214
Cancer Center of Kansas - Winfield
Winfield, Kansas, United States, 67156
United States, Louisiana
Christus Saint Frances Cabrini Hospital
Alexandria, Louisiana, United States, 71301
DeSoto Regional Health System
Mansfield, Louisiana, United States, 71052
Louisiana State University Sciences Center- Monroe
Monroe, Louisiana, United States, 71202
Highland Clinic
Shreveport, Louisiana, United States, 71105
Louisiana State University Health Sciences Center Shreveport
Shreveport, Louisiana, United States, 71130
Overton Brooks Veteran's Administration Medical Center
Shreveport, Louisiana, United States, 71101
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States, 01805
United States, Michigan
Bronson Battle Creek
Battle Creek, Michigan, United States, 49017
Spectrum Health Big Rapids Hospital
Big Rapids, Michigan, United States, 49307
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, United States, 49503
Mercy Health Saint Mary's
Grand Rapids, Michigan, United States, 49503
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, United States, 49503
Mercy Health Mercy Campus
Muskegon, Michigan, United States, 49444
Spectrum Health Reed City Hospital
Reed City, Michigan, United States, 49677
Munson Medical Center
Traverse City, Michigan, United States, 49684
United States, Missouri
North Kansas City Hospital
Kansas City, Missouri, United States, 64116
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States, 64111
Heartland Hematology and Oncology Associates Incorporated
Kansas City, Missouri, United States, 64118
Truman Medical Center
Kansas City, Missouri, United States, 64108
Saint Joseph Health Center
Kansas City, Missouri, United States, 64114
Research Medical Center
Kansas City, Missouri, United States, 64132
Saint Luke's East - Lee's Summit
Lee's Summit, Missouri, United States, 64086
Liberty Hospital
Liberty, Missouri, United States, 64068
Saint John's Clinic-Rolla-Cancer and Hematology
Rolla, Missouri, United States, 65401
Heartland Regional Medical Center
Saint Joseph, Missouri, United States, 64506
Saint Louis Cancer and Breast Institute-South City
Saint Louis, Missouri, United States, 63109
Saint John's Mercy Medical Center
Saint Louis, Missouri, United States, 63141
Ozark Health Ventures LLC-Cancer Research for The Ozarks Springfield
Springfield, Missouri, United States, 65804
Mercy Hospital Springfield
Springfield, Missouri, United States, 65804
United States, Montana
Hematology-Oncology Centers of the Northern Rockies PC
Billings, Montana, United States, 59102
Billings Clinic
Billings, Montana, United States, 59107-7000
Saint Vincent Healthcare
Billings, Montana, United States, 59101
Montana Cancer Consortium CCOP
Billings, Montana, United States, 59101
Bozeman Deaconess Hospital
Bozeman, Montana, United States, 59715
Bozeman Deaconess Cancer Center
Bozeman, Montana, United States, 59715
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, United States, 59701
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, United States, 59405
Great Falls Clinic
Great Falls, Montana, United States, 59405
Saint Peter's Community Hospital
Helena, Montana, United States, 59601
Kalispell Regional Medical Center
Kalispell, Montana, United States, 59901
Glacier Oncology PLLC
Kalispell, Montana, United States, 59901
Montana Cancer Specialists
Missoula, Montana, United States, 59802
Saint Patrick Hospital - Community Hospital
Missoula, Montana, United States, 59802
United States, New York
Arnot Ogden Medical Center
Elmira, New York, United States, 14905
Interlakes Foundation Inc-Rochester
Rochester, New York, United States, 14623
University of Rochester
Rochester, New York, United States, 14642
United States, North Carolina
Wayne Memorial Hospital
Goldsboro, North Carolina, United States, 27534
Margaret R Pardee Memorial Hospital
Hendersonville, North Carolina, United States, 28791
Park Ridge Hospital Breast Health Center
Hendersonville, North Carolina, United States, 28792
Iredell Memorial Hospital
Statesville, North Carolina, United States, 28677
Southeast Cancer Control Consortium CCOP
Winston-Salem, North Carolina, United States, 27104
United States, Ohio
Mary Rutan Hospital
Bellefontaine, Ohio, United States, 43311
Adena Regional Medical Center
Chillicothe, Ohio, United States, 45601
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Columbus CCOP
Columbus, Ohio, United States, 43215
Grant Medical Center
Columbus, Ohio, United States, 43215
Doctors Hospital
Columbus, Ohio, United States, 43228
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
Mount Carmel Health Center West
Columbus, Ohio, United States, 43222
Good Samaritan Hospital - Dayton
Dayton, Ohio, United States, 45406
Miami Valley Hospital
Dayton, Ohio, United States, 45409
Grandview Hospital
Dayton, Ohio, United States, 45405
Dayton CCOP
Dayton, Ohio, United States, 45420
Samaritan North Health Center
Dayton, Ohio, United States, 45415
Grady Memorial Hospital
Delaware, Ohio, United States, 43015
Blanchard Valley Hospital
Findlay, Ohio, United States, 45840
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, United States, 45005-1066
Wayne Hospital
Greenville, Ohio, United States, 45331
Kettering Medical Center
Kettering, Ohio, United States, 45429
Fairfield Medical Center
Lancaster, Ohio, United States, 43130
Marietta Memorial Hospital
Marietta, Ohio, United States, 45750
Knox Community Hospital
Mount Vernon, Ohio, United States, 43050
Licking Memorial Hospital
Newark, Ohio, United States, 43055
Southern Ohio Medical Center
Portsmouth, Ohio, United States, 45662
Springfield Regional Medical Center
Springfield, Ohio, United States, 45505
Upper Valley Medical Center
Troy, Ohio, United States, 45373
Saint Ann's Hospital
Westerville, Ohio, United States, 43081
Wright-Patterson Medical Center
Wright-Patterson Afb, Ohio, United States, 45433-5529
Greene Memorial Hospital
Xenia, Ohio, United States, 45385
Genesis HealthCare System
Zanesville, Ohio, United States, 43701
United States, Oregon
Saint Charles Medical Center-Bend
Bend, Oregon, United States, 97701
United States, South Carolina
AnMed Health Cancer Center
Anderson, South Carolina, United States, 29621
AnMed Health Hospital
Anderson, South Carolina, United States, 29621
Saint Francis Hospital
Greenville, South Carolina, United States, 29601
Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
Upstate Carolina CCOP
Spartanburg, South Carolina, United States, 29303
United States, Washington
Cancer Care Center at Island Hospital
Anacortes, Washington, United States, 98221
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, United States, 98225
Harrison HealthPartners Hematology and Oncology-Bremerton
Bremerton, Washington, United States, 98310
Highline Medical Center-Main Campus
Burien, Washington, United States, 98166
Swedish Medical Center-Edmonds
Edmonds, Washington, United States, 98026
Swedish Cancer Institute-Issaquah
Issaquah, Washington, United States, 98029
Columbia Basin Hematology and Oncology PLLC
Kennewick, Washington, United States, 99336
Skagit Valley Hospital
Mount Vernon, Washington, United States, 98274
Harrison HealthPartners Hematology and Oncology-Poulsbo
Poulsbo, Washington, United States, 98370
Group Health
Seattle, Washington, United States, 98109
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Minor and James Medical PLLC
Seattle, Washington, United States, 98104
Group Health Cooperative-Seattle
Seattle, Washington, United States, 98112
Harborview Medical Center
Seattle, Washington, United States, 98104
Swedish Medical Center-First Hill
Seattle, Washington, United States, 98122-4307
University of Washington Medical Center
Seattle, Washington, United States, 98195
The Polyclinic
Seattle, Washington, United States, 98122
United General Hospital
Sedro-Woolley, Washington, United States, 98284
Cancer Care Northwest - Spokane South
Spokane, Washington, United States, 99202
Evergreen Hematology and Oncology PS
Spokane, Washington, United States, 99218
Wenatchee Valley Medical Center
Wenatchee, Washington, United States, 98801
United States, Wyoming
Rocky Mountain Oncology
Casper, Wyoming, United States, 82609
Welch Cancer Center
Sheridan, Wyoming, United States, 82801
Sponsors and Collaborators
Investigators
Principal Investigator: Daniel Persky Southwest Oncology Group
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00972478     History of Changes
Other Study ID Numbers: NCI-2011-01964, NCI-2011-01964, CDR0000653803, S0806, S0806, U10CA032102
Study First Received: September 4, 2009
Last Updated: August 22, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antibodies, Monoclonal
Cyclophosphamide
Rituximab
Liposomal doxorubicin
Vorinostat
Doxorubicin
Prednisone
Vincristine
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic

ClinicalTrials.gov processed this record on August 25, 2014