- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00972478
Vorinostat, Rituximab, and Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II, Stage III, or Stage IV Diffuse Large B-Cell Lymphoma
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)
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
Alabama
-
Mobile, Alabama, United States, 36608
- Providence Hospital
-
-
Arizona
-
Tucson, Arizona, United States, 85704
- University of Arizona Cancer Center-Orange Grove Campus
-
Tucson, Arizona, United States, 85719
- Banner University Medical Center - Tucson
-
Tucson, Arizona, United States, 85719
- University of Arizona Cancer Center-North Campus
-
-
Arkansas
-
Fort Smith, Arkansas, United States, 72903
- Mercy Hospital Fort Smith
-
Jonesboro, Arkansas, United States, 72401
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
-
Jonesboro, Arkansas, United States, 72401
- NEA Baptist Memorial Hospital
-
-
California
-
Antioch, California, United States, 94531
- Kaiser Permanente-Deer Valley Medical Center
-
Duarte, California, United States, 91010
- City of Hope Comprehensive Cancer Center
-
Fremont, California, United States, 94538
- Kaiser Permanente-Fremont
-
Fresno, California, United States, 93720
- Kaiser Permanente-Fresno
-
Los Angeles, California, United States, 90033
- USC / Norris Comprehensive Cancer Center
-
Modesto, California, United States, 95356
- Kaiser Permanente-Modesto
-
Oakland, California, United States, 94611
- Kaiser Permanente-Oakland
-
Redwood City, California, United States, 94063
- Kaiser Permanente-Redwood City
-
Richmond, California, United States, 94801
- Kaiser Permanente-Richmond
-
Roseville, California, United States, 95661
- Kaiser Permanente-Roseville
-
Sacramento, California, United States, 95823
- Kaiser Permanente-South Sacramento
-
Sacramento, California, United States, 95825
- Kaiser Permanente - Sacramento
-
San Francisco, California, United States, 94115
- Kaiser Permanente-San Francisco
-
San Jose, California, United States, 95119
- Kaiser Permanente-Santa Teresa-San Jose
-
San Leandro, California, United States, 94577
- Kaiser Permanente San Leandro
-
San Rafael, California, United States, 94903
- Kaiser Permanente-San Rafael
-
Santa Clara, California, United States, 95051
- Kaiser Permanente Medical Center - Santa Clara
-
Santa Rosa, California, United States, 95403
- Kaiser Permanente-Santa Rosa
-
South San Francisco, California, United States, 94080
- Kaiser Permanente-South San Francisco
-
Stockton, California, United States, 95210
- Kaiser Permanente-Stockton
-
Vacaville, California, United States, 95688
- Kaiser Permanente Medical Center-Vacaville
-
Vallejo, California, United States, 94589
- Kaiser Permanente-Vallejo
-
Walnut Creek, California, United States, 94596
- Kaiser Permanente-Walnut Creek
-
-
Colorado
-
Fort Collins, Colorado, United States, 80524
- Poudre Valley Hospital
-
-
Connecticut
-
New Haven, Connecticut, United States, 06520
- Yale University
-
-
Georgia
-
Savannah, Georgia, United States, 31404
- Memorial Health University Medical Center
-
-
Hawaii
-
'Aiea, Hawaii, United States, 96701
- Pali Momi Medical Center
-
'Aiea, Hawaii, United States, 96701
- Queen's Cancer Center - Pearlridge
-
Honolulu, Hawaii, United States, 96813
- Queen's Medical Center
-
Honolulu, Hawaii, United States, 96813
- Hawaii Cancer Care Inc - Waterfront Plaza
-
Honolulu, Hawaii, United States, 96813
- Straub Clinic and Hospital
-
Honolulu, Hawaii, United States, 96813
- University of Hawaii Cancer Center
-
Honolulu, Hawaii, United States, 96817
- Hawaii Cancer Care Inc-Liliha
-
Honolulu, Hawaii, United States, 96817
- Kuakini Medical Center
-
Honolulu, Hawaii, United States, 96817
- Queen's Cancer Center - Kuakini
-
Honolulu, Hawaii, United States, 96826
- Kapiolani Medical Center for Women and Children
-
Honolulu, Hawaii, United States, 96819
- Kaiser Permanente Moanalua Medical Center
-
Honolulu, Hawaii, United States, 96859
- Tripler Army Medical Center
-
Kailua, Hawaii, United States, 96734
- Castle Medical Center
-
Lihue, Hawaii, United States, 96766
- Wilcox Memorial Hospital and Kauai Medical Clinic
-
-
Illinois
-
Geneva, Illinois, United States, 60134
- Northwestern Medicine Cancer Center Delnor
-
Maywood, Illinois, United States, 60153
- Loyola University Medical Center
-
Mount Vernon, Illinois, United States, 62864
- Good Samaritan Regional Health Center
-
Warrenville, Illinois, United States, 60555
- Northwestern Medicine Cancer Center Warrenville
-
-
Indiana
-
Beech Grove, Indiana, United States, 46107
- Franciscan Saint Francis Health-Beech Grove
-
Indianapolis, Indiana, United States, 46237
- Franciscan Health Indianapolis
-
Richmond, Indiana, United States, 47374
- Reid Health
-
-
Kansas
-
Chanute, Kansas, United States, 66720
- Cancer Center of Kansas - Chanute
-
Dodge City, Kansas, United States, 67801
- Cancer Center of Kansas - Dodge City
-
El Dorado, Kansas, United States, 67042
- Cancer Center of Kansas - El Dorado
-
Fort Scott, Kansas, United States, 66701
- Cancer Center of Kansas - Fort Scott
-
Great Bend, Kansas, United States, 67530
- Saint Rose Ambulatory and Surgery Center
-
Hays, Kansas, United States, 67601
- HaysMed University of Kansas Health System
-
Hutchinson, Kansas, United States, 67502
- Hutchinson Regional Medical Center
-
Independence, Kansas, United States, 67301
- Cancer Center of Kansas-Independence
-
Kansas City, Kansas, United States, 66160
- University of Kansas Cancer Center
-
Kansas City, Kansas, United States, 66112
- Providence Medical Center
-
Kingman, Kansas, United States, 67068
- Cancer Center of Kansas-Kingman
-
Lawrence, Kansas, United States, 66044
- Lawrence Memorial Hospital
-
Liberal, Kansas, United States, 67905
- Cancer Center of Kansas-Liberal
-
Newton, Kansas, United States, 67114
- Cancer Center of Kansas - Newton
-
Overland Park, Kansas, United States, 66209
- Menorah Medical Center
-
Overland Park, Kansas, United States, 66213
- Saint Luke's South Hospital
-
Parsons, Kansas, United States, 67357
- Cancer Center of Kansas - Parsons
-
Pittsburg, Kansas, United States, 66762
- Ascension Via Christi - Pittsburg
-
Prairie Village, Kansas, United States, 66208
- Kansas City NCI Community Oncology Research Program
-
Pratt, Kansas, United States, 67124
- Cancer Center of Kansas - Pratt
-
Salina, Kansas, United States, 67401
- Salina Regional Health Center
-
Salina, Kansas, United States, 67401
- Cancer Center of Kansas - Salina
-
Topeka, Kansas, United States, 66606
- University of Kansas Health System Saint Francis Campus
-
Wellington, Kansas, United States, 67152
- Cancer Center of Kansas - Wellington
-
Wichita, Kansas, United States, 67214
- Ascension Via Christi Hospitals Wichita
-
Wichita, Kansas, United States, 67208
- Cancer Center of Kansas-Wichita Medical Arts Tower
-
Wichita, Kansas, United States, 67214
- Cancer Center of Kansas - Wichita
-
Wichita, Kansas, United States, 67208
- Associates In Womens Health
-
Wichita, Kansas, United States, 67214
- Wichita NCI Community Oncology Research Program
-
Winfield, Kansas, United States, 67156
- Cancer Center of Kansas - Winfield
-
-
Louisiana
-
Alexandria, Louisiana, United States, 71301
- Christus Saint Frances Cabrini Hospital
-
Mansfield, Louisiana, United States, 71052
- DeSoto Regional Health System
-
Monroe, Louisiana, United States, 71202
- Ochsner LSU Health Monroe Medical Center
-
Shreveport, Louisiana, United States, 71103
- LSU Health Sciences Center at Shreveport
-
Shreveport, Louisiana, United States, 71105
- Highland Clinic
-
Shreveport, Louisiana, United States, 71101
- Overton Brooks Veteran's Administration Medical Center
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02118
- Boston Medical Center
-
Burlington, Massachusetts, United States, 01805
- Lahey Hospital and Medical Center
-
-
Michigan
-
Battle Creek, Michigan, United States, 49017
- Bronson Battle Creek
-
Big Rapids, Michigan, United States, 49307
- Spectrum Health Big Rapids Hospital
-
Grand Rapids, Michigan, United States, 49503
- Spectrum Health at Butterworth Campus
-
Grand Rapids, Michigan, United States, 49503
- Cancer Research Consortium of West Michigan NCORP
-
Grand Rapids, Michigan, United States, 49503
- Trinity Health Grand Rapids Hospital
-
Muskegon, Michigan, United States, 49444
- Trinity Health Muskegon Hospital
-
Reed City, Michigan, United States, 49677
- Corewell Health Reed City Hospital
-
Traverse City, Michigan, United States, 49684
- Munson Medical Center
-
-
Missouri
-
Kansas City, Missouri, United States, 64116
- North Kansas City Hospital
-
Kansas City, Missouri, United States, 64111
- Saint Luke's Hospital of Kansas City
-
Kansas City, Missouri, United States, 64132
- Research Medical Center
-
Kansas City, Missouri, United States, 64108
- Truman Medical Centers
-
Kansas City, Missouri, United States, 64118
- Heartland Hematology and Oncology Associates Incorporated
-
Kansas City, Missouri, United States, 64114
- Saint Joseph Health Center
-
Lee's Summit, Missouri, United States, 64086
- Saint Luke's East - Lee's Summit
-
Liberty, Missouri, United States, 64068
- Liberty Radiation Oncology Center
-
Rolla, Missouri, United States, 65401
- Mercy Clinic-Rolla-Cancer and Hematology
-
Saint Joseph, Missouri, United States, 64506
- Heartland Regional Medical Center
-
Saint Louis, Missouri, United States, 63141
- Mercy Hospital Saint Louis
-
Saint Louis, Missouri, United States, 63109
- Saint Louis Cancer and Breast Institute-South City
-
Springfield, Missouri, United States, 65804
- Cancer Research for the Ozarks NCORP
-
Springfield, Missouri, United States, 65804
- Mercy Hospital Springfield
-
-
Montana
-
Billings, Montana, United States, 59101
- Billings Clinic Cancer Center
-
Billings, Montana, United States, 59101
- Saint Vincent Healthcare
-
Billings, Montana, United States, 59102
- Montana Cancer Consortium NCORP
-
Billings, Montana, United States, 59102
- Saint Vincent Frontier Cancer Center
-
Bozeman, Montana, United States, 59715
- Bozeman Deaconess Hospital
-
Butte, Montana, United States, 59701
- Saint James Community Hospital and Cancer Treatment Center
-
Great Falls, Montana, United States, 59405
- Great Falls Clinic
-
Great Falls, Montana, United States, 59405
- Benefis Healthcare- Sletten Cancer Institute
-
Helena, Montana, United States, 59601
- Saint Peter's Community Hospital
-
Kalispell, Montana, United States, 59901
- Kalispell Regional Medical Center
-
Kalispell, Montana, United States, 59901
- Glacier Oncology PLLC
-
Missoula, Montana, United States, 59802
- Saint Patrick Hospital - Community Hospital
-
Missoula, Montana, United States, 59802
- Montana Cancer Specialists
-
-
New York
-
Elmira, New York, United States, 14905
- Arnot Ogden Medical Center/Falck Cancer Center
-
Rochester, New York, United States, 14642
- University of Rochester
-
Rochester, New York, United States, 14623
- Interlakes Foundation Inc-Rochester
-
-
North Carolina
-
Goldsboro, North Carolina, United States, 27534
- Wayne Memorial Hospital
-
Hendersonville, North Carolina, United States, 28791
- Margaret R Pardee Memorial Hospital
-
Hendersonville, North Carolina, United States, 28792
- AdventHealth Hendersonville
-
Statesville, North Carolina, United States, 28677
- Iredell Memorial Hospital
-
Winston-Salem, North Carolina, United States, 27104
- Southeast Clinical Oncology Research Consortium NCORP
-
-
Ohio
-
Bellefontaine, Ohio, United States, 43311
- Mary Rutan Hospital
-
Chillicothe, Ohio, United States, 45601
- Adena Regional Medical Center
-
Cincinnati, Ohio, United States, 45219
- University of Cincinnati Cancer Center-UC Medical Center
-
Columbus, Ohio, United States, 43214
- Riverside Methodist Hospital
-
Columbus, Ohio, United States, 43228
- Doctors Hospital
-
Columbus, Ohio, United States, 43215
- Grant Medical Center
-
Columbus, Ohio, United States, 43222
- Mount Carmel Health Center West
-
Columbus, Ohio, United States, 43215
- Columbus NCI Community Oncology Research Program
-
Dayton, Ohio, United States, 45406
- Good Samaritan Hospital - Dayton
-
Dayton, Ohio, United States, 45409
- Miami Valley Hospital
-
Dayton, Ohio, United States, 45415
- Miami Valley Hospital North
-
Dayton, Ohio, United States, 45405
- Grandview Hospital
-
Dayton, Ohio, United States, 45459
- Dayton NCI Community Oncology Research Program
-
Delaware, Ohio, United States, 43015
- Grady Memorial Hospital
-
Findlay, Ohio, United States, 45840
- Blanchard Valley Hospital
-
Franklin, Ohio, United States, 45005-1066
- Atrium Medical Center-Middletown Regional Hospital
-
Greenville, Ohio, United States, 45331
- Wayne Hospital
-
Kettering, Ohio, United States, 45429
- Kettering Medical Center
-
Lancaster, Ohio, United States, 43130
- Fairfield Medical Center
-
Marietta, Ohio, United States, 45750
- Marietta Memorial Hospital
-
Mount Vernon, Ohio, United States, 43050
- Knox Community Hospital
-
Newark, Ohio, United States, 43055
- Licking Memorial Hospital
-
Portsmouth, Ohio, United States, 45662
- Southern Ohio Medical Center
-
Springfield, Ohio, United States, 45505
- Springfield Regional Medical Center
-
Troy, Ohio, United States, 45373
- Upper Valley Medical Center
-
Westerville, Ohio, United States, 43081
- Saint Ann's Hospital
-
Wright-Patterson Air Force Base, Ohio, United States, 45433
- Wright-Patterson Medical Center
-
Xenia, Ohio, United States, 45385
- Greene Memorial Hospital
-
Zanesville, Ohio, United States, 43701
- Genesis Healthcare System Cancer Care Center
-
-
Oregon
-
Bend, Oregon, United States, 97701
- Saint Charles Health System
-
-
South Carolina
-
Anderson, South Carolina, United States, 29621
- AnMed Health Cancer Center
-
Anderson, South Carolina, United States, 29621
- AnMed Health Hospital
-
Greenville, South Carolina, United States, 29601
- Saint Francis Hospital
-
Spartanburg, South Carolina, United States, 29303
- Spartanburg Medical Center
-
-
Washington
-
Anacortes, Washington, United States, 98221
- Cancer Care Center at Island Hospital
-
Bellingham, Washington, United States, 98225
- PeaceHealth Saint Joseph Medical Center
-
Bremerton, Washington, United States, 98310
- Harrison HealthPartners Hematology and Oncology-Bremerton
-
Burien, Washington, United States, 98166
- Highline Medical Center-Main Campus
-
Edmonds, Washington, United States, 98026
- Swedish Cancer Institute-Edmonds
-
Issaquah, Washington, United States, 98029
- Swedish Cancer Institute-Issaquah
-
Kennewick, Washington, United States, 99336
- Kadlec Clinic Hematology and Oncology
-
Mount Vernon, Washington, United States, 98274
- Skagit Valley Hospital
-
Poulsbo, Washington, United States, 98370
- Harrison HealthPartners Hematology and Oncology-Poulsbo
-
Seattle, Washington, United States, 98109
- Fred Hutchinson Cancer Research Center
-
Seattle, Washington, United States, 98104
- Harborview Medical Center
-
Seattle, Washington, United States, 98122
- Swedish Medical Center-First Hill
-
Seattle, Washington, United States, 98195
- University of Washington Medical Center - Montlake
-
Seattle, Washington, United States, 98112
- Kaiser Permanente Washington
-
Seattle, Washington, United States, 98104
- Minor and James Medical PLLC
-
Sedro-Woolley, Washington, United States, 98284
- PeaceHealth United General Medical Center
-
Spokane, Washington, United States, 99218
- Evergreen Hematology and Oncology PS
-
Spokane, Washington, United States, 99202
- Cancer Care Northwest - Spokane South
-
Wenatchee, Washington, United States, 98801
- Wenatchee Valley Hospital and Clinics
-
-
Wyoming
-
Casper, Wyoming, United States, 82609
- Rocky Mountain Oncology
-
Sheridan, Wyoming, United States, 82801
- Welch Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
Correlative studies
Given IV
Other Names:
Given IV
Other Names:
Given IV
Other Names:
Given IV
Other Names:
Given PO
Other Names:
Given IV
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safe Dose of Vorinostat to be Used in Combination With R-CHOP Assessed by CTCAE Version 4.0 (Phase I)
Time Frame: 21 days
|
Safe dose of Vorinostat (in combination with R-CHOP) at which 3/10 or fewer patients have doselimiting toxicities (DLT).
Toxicities graded according to the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE 4.0).
DLT apply only during cycle 1 and should be drug-related (possible, probable, or definite).
|
21 days
|
Progression-free Survival (Phase II)
Time Frame: Up to 2 years
|
From date of registration to date of first documentation of progressive disease, or death due to any cause.
Patients last known to be alive and progression free are censored at date of last contact.
|
Up to 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival (Phase II)
Time Frame: Up to 2 years
|
From date of registration to date of death due to any cause.
Patients last known to be alive are censored at date of last contact.
|
Up to 2 years
|
Response Rate (Complete Response [CR]+Partial Response [PR]) (Phase II)
Time Frame: Up to week 26
|
Objective disease status is evaluated according to the 2007 revised Cheson et al. criteria.
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.
Partial Response (PR) is a 50% decrease in the sum of products of greatest diameters (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.
|
Up to week 26
|
Toxicity of Vorinostat-R-CHOP in Patients With Newly Diagnosed DLBCL
Time Frame: Up to week 26
|
Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
For each patient, worst grade of each event type is reported.
Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.
|
Up to week 26
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Daniel O Persky, SWOG Cancer Research Network
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, B-Cell
- Lymphoma
- Lymphoma, Large B-Cell, Diffuse
- Lymphoma, Non-Hodgkin
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Histone Deacetylase Inhibitors
- Cyclophosphamide
- Antibodies
- Immunoglobulins
- Rituximab
- Prednisone
- Doxorubicin
- Liposomal doxorubicin
- Antibodies, Monoclonal
- Antineoplastic Agents, Immunological
- Vincristine
- Vorinostat
- Cortisone
Other Study ID Numbers
- NCI-2011-01964 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- U10CA032102 (U.S. NIH Grant/Contract)
- U10CA180888 (U.S. NIH Grant/Contract)
- CDR0000653803
- S0806 (Other Identifier: CTEP)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ann Arbor Stage III Non-Hodgkin Lymphoma
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingAnn Arbor Stage I Grade 1 Follicular Lymphoma | Ann Arbor Stage I Grade 2 Follicular Lymphoma | Ann Arbor Stage II Grade 1 Follicular Lymphoma | Ann Arbor Stage II Grade 2 Follicular Lymphoma | Ann Arbor Stage IV B-Cell Non-Hodgkin Lymphoma | Ann Arbor Stage I B-Cell Non-Hodgkin Lymphoma | Ann... and other conditionsUnited States
-
Academic and Community Cancer Research UnitedNational Cancer Institute (NCI)Active, not recruitingAnn Arbor Stage III Hodgkin Lymphoma | Ann Arbor Stage IIIA Hodgkin Lymphoma | Ann Arbor Stage IIIB Hodgkin Lymphoma | Ann Arbor Stage IV Hodgkin Lymphoma | Ann Arbor Stage IVA Hodgkin Lymphoma | Ann Arbor Stage IVB Hodgkin Lymphoma | Classic Hodgkin Lymphoma | Ann Arbor Stage IB Hodgkin Lymphoma | Ann... and other conditionsUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedAnn Arbor Stage III Grade 1 Follicular Lymphoma | Ann Arbor Stage III Grade 2 Follicular Lymphoma | Ann Arbor Stage III Indolent Adult Non-Hodgkin Lymphoma | Ann Arbor Stage IV Grade 1 Follicular Lymphoma | Ann Arbor Stage IV Grade 2 Follicular Lymphoma | Ann Arbor Stage IV Indolent Adult Non-Hodgkin... and other conditionsUnited States
-
National Cancer Institute (NCI)Active, not recruitingAnn Arbor Stage III Hodgkin Lymphoma | Ann Arbor Stage III Lymphocyte-Depleted Classic Hodgkin Lymphoma | Ann Arbor Stage III Mixed Cellularity Classic Hodgkin Lymphoma | Ann Arbor Stage III Nodular Sclerosis Classic Hodgkin Lymphoma | Ann Arbor Stage IV Hodgkin Lymphoma | Ann Arbor Stage IV... and other conditionsUnited States, Canada, Puerto Rico
-
National Cancer Institute (NCI)The Lymphoma Academic Research OrganisationActive, not recruitingHIV Infection | Ann Arbor Stage III Hodgkin Lymphoma | Ann Arbor Stage IIIA Hodgkin Lymphoma | Ann Arbor Stage IIIB Hodgkin Lymphoma | Ann Arbor Stage IV Hodgkin Lymphoma | Ann Arbor Stage IVA Hodgkin Lymphoma | Ann Arbor Stage IVB Hodgkin Lymphoma | Classic Hodgkin Lymphoma | Ann Arbor Stage II Hodgkin... and other conditionsUnited States, France
-
National Cancer Institute (NCI)Celgene CorporationActive, not recruitingAnn Arbor Stage III Grade 1 Follicular Lymphoma | Ann Arbor Stage III Grade 2 Follicular Lymphoma | Ann Arbor Stage IV Grade 1 Follicular Lymphoma | Ann Arbor Stage IV Grade 2 Follicular Lymphoma | Ann Arbor Stage II Grade 3 Contiguous Follicular Lymphoma | Ann Arbor Stage II Grade 3 Non-Contiguous... and other conditionsUnited States
-
National Cancer Institute (NCI)CompletedAnn Arbor Stage III Grade 1 Follicular Lymphoma | Ann Arbor Stage III Grade 2 Follicular Lymphoma | Ann Arbor Stage IV Grade 1 Follicular Lymphoma | Ann Arbor Stage IV Grade 2 Follicular Lymphoma | Ann Arbor Stage II Grade 3 Contiguous Follicular Lymphoma | Ann Arbor Stage II Grade 3 Non-Contiguous... and other conditionsUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Genentech, Inc.; Pharmacyclics LLC.RecruitingNon-Hodgkin's Lymphoma | Indolent Non-hodgkin Lymphoma | Ann Arbor Stage II Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue | Ann Arbor Stage II Follicular Lymphoma | Ann Arbor Stage II Nodal Marginal Zone Lymphoma | Ann Abor Stage III B-Cell Non-Hodgkin Lymphoma | Ann Arbor... and other conditionsUnited States
-
Mayo ClinicNational Cancer Institute (NCI)CompletedAnn Arbor Stage I Grade 1 Follicular Lymphoma | Ann Arbor Stage I Grade 2 Follicular Lymphoma | Ann Arbor Stage III Grade 1 Follicular Lymphoma | Ann Arbor Stage III Grade 2 Follicular Lymphoma | Ann Arbor Stage IV Grade 1 Follicular Lymphoma | Ann Arbor Stage IV Grade 2 Follicular Lymphoma | Ann... and other conditionsUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingGrade 3a Follicular Lymphoma | Ann Arbor Stage III Grade 1 Follicular Lymphoma | Ann Arbor Stage III Grade 2 Follicular Lymphoma | Ann Arbor Stage IV Grade 1 Follicular Lymphoma | Ann Arbor Stage IV Grade 2 Follicular Lymphoma | Ann Arbor Stage III Grade 3 Follicular Lymphoma | Ann Arbor Stage...United States
Clinical Trials on Laboratory Biomarker Analysis
-
ECOG-ACRIN Cancer Research GroupNational Cancer Institute (NCI)CompletedProstate Cancer
-
National Cancer Institute (NCI)Recruiting
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)Not yet recruitingLynch Syndrome | Recurrent Uterine Corpus Carcinoma | Stage I Uterine Corpus Cancer | Stage II Uterine Corpus Cancer | Stage III Uterine Corpus Cancer | Stage IV Uterine Corpus CancerUnited States
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)Not yet recruitingRecurrent Uterine Corpus Carcinoma | Stage III Uterine Corpus Cancer | Stage IV Uterine Corpus CancerUnited States
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)RecruitingStage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian CancerUnited States
-
Ohio State University Comprehensive Cancer CenterActive, not recruitingLung Cancer | Radiation Toxicity | Adult Brain TumorUnited States
-
National Cancer Institute (NCI)Active, not recruitingMalignant NeoplasmUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedRecurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor | Metastatic Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor | Localized Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor | Askin TumorUnited States, Canada, Puerto Rico, Australia, New Zealand, Switzerland
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)Completed
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedRecurrent Osteosarcoma | Metastatic Osteosarcoma | Localized OsteosarcomaUnited States