Vorinostat, Rituximab, and Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II, Stage III, or Stage IV Diffuse Large B-Cell Lymphoma



Status:Active, not recruiting
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/17/2019
Start Date:November 15, 2010

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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)

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.

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.

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
We found this trial at
190
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3333 W Deyoung St
Saint Joseph, Missouri 64506
(618) 998-7000
Heartland Regional Medical Center Heartland Regional Medical Center is your community healthcare provider; a 98-bed...
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1500 E Duarte Rd
Duarte, California 91010
(626) 256-4673
City of Hope Comprehensive Cancer Center City of Hope is a leading research and treatment...
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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1100 Fairview Avenue North
Seattle, Washington 98109
(206) 667-5000
Fred Hutchinson Cancer Research Center At Fred Hutchinson Cancer Research Center, our interdisciplinary teams of...
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601 South Sherman Street
Spokane, Washington 99202
(509) 228-1000
Cancer Care Northwest - Spokane South Cancer Care Northwest is the Inland Northwest’s premier cancer...
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98-1079 Moanalua Road
'Aiea, Hawaii 96701
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'Aiea, Hawaii 96701
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Alexandria, Louisiana 71301
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Anacortes, Washington 98221
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Anderson, South Carolina 29621
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2000 E Greenville St
Anderson, South Carolina 29621
(864) 512-4640
AnMedical Health Cancer Center Cancer is the general term for a group of more than...
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265 Fremont St
Battle Creek, Michigan 49017
(269) 245-8166
Bronson Battle Creek As a proud member of the Battle Creek community, we believe everyone...
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Beech Grove, Indiana 46107
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205 Palmer Ave.
Bellefontaine, Ohio 43311
937.592.4015
Mary Rutan Hospital The hospital was endowed by the sale of a farm in Ridgeway...
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Bellingham, Washington 98225
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Bend, Oregon 97701
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Big Rapids, Michigan 49307
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Billings, Montana 59101
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Billings, Montana 59101
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1233 North 30th Street
Billings, Montana 59101
406-237-7000
Saint Vincent Healthcare The Sisters of Charity of Leavenworth, Kansas, founded St. Vincent Healthcare in...
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Billings, Montana 59102
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Boston, Massachusetts 02118
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915 Highland Blvd
Bozeman, Montana 59715
(406) 414-5000
Bozeman Deaconess Hospital Bozeman Deaconess Hospital is a Joint Commission certified, licensed Level III trauma...
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Burien, Washington 98166
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Burlington, Massachusetts 01805
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400 South Clark Street
Butte, Montana 59701
406-723-2500
Saint James Community Hospital and Cancer Treatment Center St. James Healthcare has played an important...
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6501 E 2nd St
Casper, Wyoming 82609
(307) 235-5433
Rocky Mountain Oncology Rocky Mountain Oncology Center is a spacious, comfortable, state-of-the-art 19,000 square foot...
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505 S Plummer Ave
Chanute, Kansas 66720
(620) 431-7580
Cancer Center of Kansas, PA - Chanute Dr. H.E. Hynes founded Cancer Center of Kansas,...
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272 Hospital Rd
Chillicothe, Ohio 45601
740-779-7500
Adena Regional Medical Center Since 1895, Adena Health System has remained focused on its commitment...
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5100 W Broad St
Columbus, Ohio 43228
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Columbus, Ohio 43222
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111 S Grant Ave
Columbus, Ohio 43215
(614) 566-9000
Grant Medical Center Founded in 1900 in Columbus' downtown, Grant has grown into one of...
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3535 Olentangy River Rd
Columbus, Ohio 43214
(614) 566-5000
Riverside Methodist Hospital Serving central Ohio since 1892, Riverside Methodist Hospital is consistently ranked one...
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1 Wyoming St,
Dayton, Ohio 45409
(937) 208-8000
Miami Valley Hospital Miami Valley Hospital (MVH) is passionate about providing the most recent medical...
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2222 Philadelphia Dr
Dayton, Ohio 45406
(937) 734-2612
Good Samaritan Hospital - Dayton Good Samaritan Hospital (GSH) is passionate about providing the most...
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Dayton, Ohio 45415
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405 W Grand Ave
Dayton, Ohio 45405
(937) 723-3200
Grandview Hospital You'll feel like part of our family when you visit Grandview Medical Center...
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561 W. Central Avenue
Delaware, Ohio 43015
(740) 615-1000
Grady Memorial Hospital As the center of healthcare in Delaware County, Grady Memorial Hospital is...
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2020 Central Ave
Dodge City, Kansas 67801
(620) 227-2488
Cancer Center of Kansas, PA - Dodge City Dr. H.E. Hynes founded Cancer Center of...
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Edmonds, Washington 98026
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700 West Central
El Dorado, Kansas 67042
(316) 889-0099
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1900 S Main St
Findlay, Ohio 45840
(419) 423-4500
Blanchard Valley Hospital For more than 100 years, Blanchard Valley Hospital has made quality care...
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1024 S Lemay Ave
Fort Collins, Colorado 80524
(970) 495-7000
Poudre Valley Hospital A 270-bed regional medical center offering a wide array of treatments, surgeries,...
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Fort Scott, Kansas 66701
(620) 223-8589
Cancer Center of Kansas - Fort Scott Dr. H.E. Hynes founded Cancer Center of Kansas,...
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Fort Smith, Arkansas 72903
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One Medical Center Drive
Franklin, Ohio 45005
(513) 424-2111
Atrium Medical Center - Middletown Regional Hospital Atrium Medical Center (Atrium) is built on the...
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39400 Paseo Padre Parkway
Fremont, California 94538
(510) 248-3000
Kaiser Permanente - Fremont You can rely on Kaiser Permanente for quality care, delivered with...
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Fresno, California 93720
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2700 Wayne Memorial Dr
Goldsboro, North Carolina 27534
(919) 736-1110
Wayne Memorial Hospital Wayne Memorial Hospital, an affiliate of Wayne Health Corporation, is home to...
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100 Michigan St NE
Grand Rapids, Michigan 49503
(616) 391-1774
Spectrum Health at Butterworth Campus Butterworth Hospital is one of four facilities that make up...
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Grand Rapids, Michigan 49503
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Great Bend, Kansas 67530
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1117 29th St S
Great Falls, Montana 59405
(406) 771-7300
Benefis Healthcare- Sletten Cancer Institute Benefis Hospitals has 516 beds at its two campuses (that...
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1400 29th Street South
Great Falls, Montana 59405
406-454-2171
Great Falls Clinic Founded in 1917, the Great Falls Clinic is the fourth oldest medical...
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835 Sweitzer St
Greenville, Ohio 45331
(937) 548-1141
Wayne Hospital Stretching back to our roots nearly 100 years ago, Wayne HealthCare has always...
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1 St. Francis Drive
Greenville, South Carolina 29601
864-255-1000
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2220 Canterbury Drive
Hays, Kansas 67601
785.623.5000
Hays Medical Center Hays Medical Center is a private, not-for-profit hospital formed by the 1991...
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Helena, Montana 59601
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Hendersonville, North Carolina 28791
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Hendersonville, North Carolina 28792
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1319 Punahou St
Honolulu, Hawaii 96826
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Kapiolani Medical Center for Women and Children Hawai‘i Pacific Health is an integrated health care...
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347 N Kuakini St
Honolulu, Hawaii 96817
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Kuakini Medical Center Kuakini is a 250-bed acute care hospital accredited by the Joint Commission...
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1301 Punchbowl St
Honolulu, Hawaii 96813
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Queen's Medical Center The Queen's Medical Center, located in downtown Honolulu, Hawaii, is a private,...
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1 Jarrett White Rd
Honolulu, Hawaii 96859
(808) 433-6661
Tripler Army Medical Center The attack of Pearl Harbor led to the construction of Tripler...
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888 S King St
Honolulu, Hawaii 96813
(808) 522-4000
Straub Clinic And Hospital Founded in 1921, Straub Clinic & Hospital is a fully integrated...
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Honolulu, Hawaii 96813
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Honolulu, Hawaii 96813
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Honolulu, Hawaii 96817
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Honolulu, Hawaii 96817
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Hutchinson, Kansas 67502
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800 W. Laurel
Independence, Kansas 67301
620-331-4099
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8111 South Emerson Avenue
Indianapolis, Indiana 46237
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Issaquah, Washington 98029
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Jonesboro, Arkansas 72401
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Jonesboro, Arkansas 72401
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640 Ulukahiki St,
Kailua, Hawaii 96734
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Castle Medical Center A full-service medical center offering a wide range of inpatient, outpatient, and...
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310 Sunnyview Ln
Kalispell, Montana 59901
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Kalispell Regional Medical Center Nestled in the beautiful Flathead Valley of Northwestern Montana, Kalispell Regional...
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75 Claremont St Ste E
Kalispell, Montana 59901
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Glacier Oncology, PLLC Glacier Oncology are physician clinics focusing exclusively on the medical subspecialties of...
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8929 Parallel Pkwy
Kansas City, Kansas 66112
(913) 596-4000
Providence Medical Center At Providence Medical Center you will discover quality doctors, innovative technology and...
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Kansas City, Kansas 66160
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Kansas City, Missouri 64114
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5400 N Oak Trafficway, Suite 101
Kansas City, Missouri 64118
(855) 603-3282
Heartland Hematology Oncology Associates, Incorporated Heartland Hematology-Oncology Associates PA in Kansas, Missouri, is a private...
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2301 Holmes
Kansas City, Missouri 64108
816-404-1000
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4401 Wornall Rd
Kansas City, Missouri 64111
(816) 932-2000
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2316 E Meyer Blvd
Kansas City, Missouri 64132
(816) 276-4000
Research Medical Center Research Medical Center offers hospital and health clinic services across three Kansas...
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2800 Clay Edwards Dr
Kansas City, Missouri 64116
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North Kansas City Hospital Generations of Northlanders have considered North Kansas City Hospital as their...
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Kennewick, Washington 99336
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3535 Southern Blvd
Kettering, Ohio 45429
(937) 298-4331
Kettering Medical Center Our flagship hospital, Kettering Medical Center, stands proudly in Kettering, Ohio. From...
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750 Avenue D West
Kingman, Kansas 67068
(620) 532-3147
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401 N Ewing St
Lancaster, Ohio 43130
(740) 687-8000
Fairfield Medical Center We are people you know offering care you trust. Serving more than...
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325 Maine Street
Lawrence, Kansas 66044
(785) 505-5000
Lawrence Memorial Hospital Lawrence Memorial Hospital (LMH), in collaboration with its medical staff, is dedicated...
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100 NE St Lukes Blvd
Lee's Summit, Missouri 64086
(816) 347-5000
Saint Luke's East - Lee's Summit Founded in 2006, Saint Luke
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