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ACTIVE NOT RECRUITING

NCT00972478

PHASE1/PHASE2

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

Sponsor: National Cancer Institute (NCI)

View on ClinicalTrials.gov

Summary

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.

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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2010-11-15

Completion Date

2026-03-06

Last Updated

2025-09-09

Healthy Volunteers

Conditions

Ann Arbor Stage II Non-Hodgkin Lymphoma Ann Arbor Stage III Non-Hodgkin Lymphoma Ann Arbor Stage IV Non-Hodgkin Lymphoma

Interventions

DRUG

Cyclophosphamide

Given IV

DRUG

Doxorubicin Hydrochloride

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Prednisone

Given IV

BIOLOGICAL

Rituximab

Given IV

DRUG

Vincristine Sulfate

Given IV

DRUG

Vorinostat

Given PO

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

Locations (190)

Providence Hospital

Mobile, Alabama, United States

University of Arizona Cancer Center-Orange Grove Campus

Tucson, Arizona, United States

Banner University Medical Center - Tucson

Tucson, Arizona, United States

University of Arizona Cancer Center-North Campus

Tucson, Arizona, United States

Mercy Hospital Fort Smith

Fort Smith, Arkansas, United States

NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro

Jonesboro, Arkansas, United States

NEA Baptist Memorial Hospital

Jonesboro, Arkansas, United States

Kaiser Permanente-Deer Valley Medical Center

Antioch, California, United States

City of Hope Comprehensive Cancer Center

Duarte, California, United States

Kaiser Permanente-Fremont

Fremont, California, United States

Kaiser Permanente-Fresno

Fresno, California, United States

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

Kaiser Permanente-Modesto

Modesto, California, United States

Kaiser Permanente-Oakland

Oakland, California, United States

Kaiser Permanente-Redwood City

Redwood City, California, United States

Kaiser Permanente-Richmond

Richmond, California, United States

Kaiser Permanente-Roseville

Roseville, California, United States

Kaiser Permanente-South Sacramento

Sacramento, California, United States

Kaiser Permanente Sacramento Medical Center

Sacramento, California, United States

Kaiser Permanente-San Francisco

San Francisco, California, United States

Kaiser Permanente-Santa Teresa-San Jose

San Jose, California, United States

Kaiser Permanente San Leandro

San Leandro, California, United States

Kaiser Permanente-San Rafael

San Rafael, California, United States

Kaiser Permanente Medical Center - Santa Clara

Santa Clara, California, United States

Kaiser Permanente-Santa Rosa

Santa Rosa, California, United States

Kaiser Permanente-South San Francisco

South San Francisco, California, United States

Kaiser Permanente-Stockton

Stockton, California, United States

Kaiser Permanente Medical Center-Vacaville

Vacaville, California, United States

Kaiser Permanente-Vallejo

Vallejo, California, United States

Kaiser Permanente-Walnut Creek

Walnut Creek, California, United States

Poudre Valley Hospital

Fort Collins, Colorado, United States

Yale University

New Haven, Connecticut, United States

Memorial Health University Medical Center

Savannah, Georgia, United States

Hawaii Cancer Care Inc - Waterfront Plaza