Page last updated: 2024-11-04

vorinostat and B Virus Infection

vorinostat has been researched along with B Virus Infection in 2 studies

Vorinostat: A hydroxamic acid and anilide derivative that acts as a HISTONE DEACETYLASE inhibitor. It is used in the treatment of CUTANEOUS T-CELL LYMPHOMA and SEZARY SYNDROME.
vorinostat : A dicarboxylic acid diamide comprising suberic (octanedioic) acid coupled to aniline and hydroxylamine. A histone deacetylase inhibitor, it is marketed under the name Zolinza for the treatment of cutaneous T cell lymphoma (CTCL).

Research

Studies (2)

Timeframe	Studies, this research(%)	All Research%
pre-1990	0 (0.00)	18.7374
1990's	0 (0.00)	18.2507
2000's	0 (0.00)	29.6817
2010's	1 (50.00)	24.3611
2020's	1 (50.00)	2.80

Authors

Authors	Studies
Ramos, JC	2
Sparano, JA	1
Chadburn, A	1
Reid, EG	1
Ambinder, RF	1
Siegel, ER	1
Moore, PC	1
Rubinstein, PG	1
Durand, CM	1
Cesarman, E	1
Aboulafia, D	1
Baiocchi, R	1
Ratner, L	1
Kaplan, L	1
Capoferri, AA	1
Lee, JY	1
Mitsuyasu, R	1
Noy, A	1
Bhatt, S	1
Ashlock, BM	1
Toomey, NL	1
Diaz, LA	1
Mesri, EA	1
Lossos, IS	1

Clinical Trials (1)

Trial Overview

Trial			Phase	Enrollment	Study Type	Start Date	Status
A Sequential Phase I/Randomized Phase II Trial of Vorinostat and Risk-Adapted Chemotherapy With Rituximab in HIV-Related B-Cell Non-Hodgkin's Lymphoma[NCT01193842]			Phase 1/Phase 2	107 participants (Actual)	Interventional	2010-10-06	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Event-free Survival (EFS) (Phase II)

The percentage of participants surviving without events (relapse or death) one year after starting treatment. (NCT01193842)
Timeframe: 1 year

Intervention	percentage of participants (Number)
Phase II: VR-DA-EPOCH	75.6
Phase II: DA-R-EPOCH	82.2

Overall Survival (OS) (Phase II)

The percentage of participants surviving one year after starting treatment. (NCT01193842)
Timeframe: 1 year

Intervention	percentage of participants (Number)
Phase II: VR-DA-EPOCH	77.6
Phase II: DA-R-EPOCH	86.7

Percentage of Participants With Complete Response (CR) as Assessed by Response Evaluation Criteria in Solid Tumors (Phase II)

"Percentage of participants with complete response as assessed by Response Evaluation Criteria in Solid Tumors (Phase II) according to treatment arm. Participants are planned to be treated for a total of 6 cycles (21 day cycle length). Participants with CR after Cycle 4 will receive two additional cycles of chemotherapy and complete 6 cycles of chemotherapy. Participants who achieve a partial response (PR) only after Cycle 4 may continue on protocol therapy or they may be removed from the study at the AMC discretion of the physician (local Principal Investigator). Participants with stable disease after 4 cycles (i.e., who did not achieve at least a PR) or progressive disease at any time will be removed from study.~In phase II, there are two arms: Vorinostat RPTD+rituximab-DA-EPOCH arm (VR-DA-EPOCH) and Rituximab-DA-EPOCH arm (DA-R-EPOCH)." (NCT01193842)
Timeframe: Up to 6 months

Intervention	percentage of participants (Number)
Phase II: VR-DA-EPOCH	67.5
Phase II: DA-R-EPOCH	76.2

Recommended Phase II Dose of Vorinostat Determined According to Dose-limiting Toxicities Graded Using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0) (Phase I)

Recommended phase II dose of vorinostat is defined as the dose level at which 0/6 or 1/6 subjects experience dose limiting toxicity (DLT) with the next higher dose having at least 2/3 or 2/6 subjects encountering DLT (Phase I). Toxicities will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Using a 3+3 design, the recommended phase II dose is defined as the level at which 0/6 or 1/6 patients experiences at dose-limiting toxicity in the first cycle. (NCT01193842)
Timeframe: 21 days

Intervention	Mg per day of Vorinostat (Number)
Phase I: VR-DA-EPOCH	300

Change in CD8 Cell Counts (Phase I)

Differences from baseline (specified follow-up assessment minus baseline) in absolute CD8 counts. (NCT01193842)
Timeframe: Baseline up to 12 months

Intervention	cells/mm^3 (Median)
	End of cycle 2	Treatment discontinuation	6-month follow-up	12-month follow-up
Phase I: VR-CHOP, Dose Level 1	-172	-81	-16	128
Phase I: VR-DA-EPOCH, Dose Level 1	35.5	-164.5	-56	604
Phase I: VR-DA-EPOCH, Dose Level 2	-115	211	275	154

Change in Plasma Associated Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) (Phase I)

Differences from baseline (specified follow-up assessment minus baseline) in HIV viral load. Undetectable viral load results were treated as 0 values. (NCT01193842)
Timeframe: Baseline up to 12 months

Intervention	copies per milliliter (Median)
	End of cycle 2	Treatment discontinuation	6-month follow-up	12-month follow-up
Phase I: VR-CHOP, Dose Level 1	28	0	0	0
Phase I: VR-DA-EPOCH, Dose Level 1	-14518	-4517	-55116	0
Phase I: VR-DA-EPOCH, Dose Level 2	-12.5	0	0	0

Changes in Absolute CD4 Cell Counts (Phase I)

Differences from baseline (specified follow-up assessment minus baseline) in absolute CD4 counts. (NCT01193842)
Timeframe: Baseline up to 12 months

Intervention	cell/mm^3 (Median)
	End of cycle 2	Treatment discontinuation	6-month follow-up	12-month follow-up
Phase I: VR-CHOP, Dose Level 1	-218	-190	-175	-84
Phase I: VR-DA-EPOCH, Dose Level 1	92	-39	76	169
Phase I: VR-DA-EPOCH, Dose Level 2	-9	-29	31	31

Changes in Epstein-Barr Virus (EBV) Viral Load

Differences from baseline (specified follow-up assessment minus baseline) in EBV viral load. (NCT01193842)
Timeframe: Baseline up to 12 months

,,,

Intervention	IU/mL (Median)
	End of Cycle 2	At treatment discontinuation	6-month follow-up	12-month follow-up
Phase I: VR-DA-EPOCH, Dose Level 1	0	0	0	0
Phase I: VR-DA-EPOCH, Dose Level 2	-2436.1	-1.92	-1.92	-1.15
Phase II, DA-R-EPOCH	0	-0.28	0	-2.7
Phase II, VR-DA-EPOCH	-0.61	-2.9	-1.55	-0.56

Changes in Human Herpes Virus (HHV)-8 Viral Load

Differences from baseline (specified follow-up assessment minus baseline) in (HHV)-8 viral load. (NCT01193842)
Timeframe: Baseline up to 12 months

Intervention	copies per 100uL (Median)
	12-month follow-up
Phase II: VR-DA-EPOCH	0

Changes in Human Herpes Virus (HHV)-8 Viral Load

Differences from baseline (specified follow-up assessment minus baseline) in (HHV)-8 viral load. (NCT01193842)
Timeframe: Baseline up to 12 months

Intervention	copies per 100uL (Median)
	At treatment discontinuation	6-month follow-up	12-month follow-up
Phase II: DA-R-EPOCH	0	0	0

Changes in Human Immunodeficiency Virus (HIV) Viral Load

Intervention	median change in copies per mL (Median)
	End of Cycle 2	At treatment discontinuation	6-month follow-up	12-month follow-up
Phase II: DA-R-EPOCH	-25	-22.5	-18	-20
Phase II: VR-DA-EPOCH	-20	-87	-20	0

Percentage of Participant Experiencing Adverse Events (AEs) for Each Treatment Arm as Assessed by Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0) (Phase II)

The percentage of participants with AEs and their worst severity will be tabulated for each treatment arm. If a participant has more than one AE, the most severe AE is analyzed. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any serious AE (SAE) that the investigator considers related to protocol therapy. (NCT01193842)
Timeframe: Up to 5 years

Intervention	percentage of participants (Number)
	Death	Life-threatening	Severe	Moderate	Mild
Phase II: DA-R-EPOCH	20.0	28.9	31.1	17.8	0
Phase II: VR-DA-EPOCH	28.9	37.8	20.0	8.9	2.2

Pharmacokinetic Clearance (Phase I)

Serial plasma samples for pharmacokinetic analysis were collected at 24-48, 48-72, and 72-96 hours after the start of the first chemotherapy infusion. Doxorubicin, etoposide, and vincristine concentrations were determined using a validated liquid chromatography-tandem mass spectrometry method. The clearance was determined by dividing the drug-infusion rate by the steady-state concentrations, which was the average of the three time points. (NCT01193842)
Timeframe: 24-48, 48-72, and 72-96 hours after the start of the first chemotherapy infusion

Intervention	Liter/hour (Mean)
	Doxorubicin	Etoposide	Vincristine
Phase I: VR-DA-EPOCH, Dose Level 1	78.6	3.0	22.4
Phase I: VR-DA-EPOCH, Dose Level 2	76.0	2.4	16.8

Tumor Response (Phase I)

The percentage of participants whose best tumor response is complete response (CR) or partial response (PR). Based on clinical, radiologic (CT), and pathologic criteria, CR requires 1) complete disappearance of all detectable disease and disease-related symptoms if present before therapy, 2) bone marrow aspirate and biopsy to confirm a CR if initially positive or if clinically indicated by new abnormalities in the peripheral blood counts or blood smear, 3) negative PET results, depending on typically, variably, or unknown pre-treatment FDG status, and 4) spleen and/or liver, if considered to be enlarged before therapy on physical examination or CT scan, not being palpable on physical examination and considered normal size by imaging studies, and nodules related to lymphoma disappeared. PR includes 1) ≥50% decrease in sum of product of diameters (SPD), 2) no increase in size of nodes, liver, or spleen, 3) splenic/hepatic nodules regressed by ≥ 50% SPD, 4) no new sites of disease (NCT01193842)
Timeframe: Up to 2 years post treatment

Intervention	percentage of participants (Number)
	Complete response	Partial Response
Phase I: Arm C (VR-CHOP) Dose Level 1	100	0
Phase I: VR-DA-EPOCH, Dose Level 1	83.3	16.7
Phase I: VR-DA-EPOCH, Dose Level 2	83.3	16.7

Trials

1 trial available for vorinostat and B Virus Infection

Article	Year
Impact of Myc in HIV-associated non-Hodgkin lymphomas treated with EPOCH and outcomes with vorinostat (AMC-075 trial). Blood, 2020, 09-10, Volume: 136, Issue:11 Topics: Adult; Aged; Anti-HIV Agents; Antineoplastic Combined Chemotherapy Protocols; CD4 Lymphocyte Count;	2020

Other Studies

1 other study available for vorinostat and B Virus Infection

Article	Year
Efficacious proteasome/HDAC inhibitor combination therapy for primary effusion lymphoma. The Journal of clinical investigation, 2013, Volume: 123, Issue:6 Topics: Animals; Antineoplastic Combined Chemotherapy Protocols; Apoptosis; Boronic Acids; Bortezomib; Cell	2013