Page last updated: 2024-11-04

vorinostat and Neutropenia

vorinostat has been researched along with Neutropenia in 6 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).

Neutropenia: A decrease in the number of NEUTROPHILS found in the blood.

Research Excerpts

ExcerptRelevanceReference
"Lenalidomide has multifaceted antimyeloma properties, including direct tumoricidal and immunomodulatory effects."6.55Lenalidomide in combination or alone as maintenance therapy following autologous stem cell transplant in patients with multiple myeloma: a review of options for and against. ( Anderson, KC; Attal, M; Holstein, SA; McCarthy, PL; Richardson, PG; Schlossman, RL, 2017)
"Vorinostat-XP is a feasible first-line chemotherapy for patients with advanced GC."2.82Vorinostat in combination with capecitabine plus cisplatin as a first-line chemotherapy for patients with metastatic or unresectable gastric cancer: phase II study and biomarker analysis. ( Kang, YK; Lee, CW; Na, YS; Ryoo, BY; Ryu, MH; Yoo, C, 2016)
" There was no clear relationship between vorinostat dosage and drug exposure over the dose range studied."2.78A pediatric phase 1 trial of vorinostat and temozolomide in relapsed or refractory primary brain or spinal cord tumors: a Children's Oncology Group phase 1 consortium study. ( Ahern, C; Ames, MM; Blaney, SM; Fouladi, M; Gilbertson, RJ; Horton, T; Hummel, TR; Ingle, AM; McGovern, RM; Reid, JM; Wagner, L; Weigel, B, 2013)
"Vorinostat was administered orally daily starting at 180 mg/m(2)/d with escalations planned in 30% increments."2.75Pediatric phase I trial and pharmacokinetic study of vorinostat: a Children's Oncology Group phase I consortium report. ( Adamson, PC; Ames, MM; Blaney, SM; Fouladi, M; Gilbertson, RJ; Ingle, AM; Park, JR; Reid, JM; Schaiquevich, P; Speights, R; Stewart, CF; Sun, J; Zwiebel, J, 2010)
"Lenalidomide has multifaceted antimyeloma properties, including direct tumoricidal and immunomodulatory effects."2.55Lenalidomide in combination or alone as maintenance therapy following autologous stem cell transplant in patients with multiple myeloma: a review of options for and against. ( Anderson, KC; Attal, M; Holstein, SA; McCarthy, PL; Richardson, PG; Schlossman, RL, 2017)

Research

Studies (6)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's0 (0.00)29.6817
2010's5 (83.33)24.3611
2020's1 (16.67)2.80

Authors

AuthorsStudies
Ramos, JC1
Sparano, JA1
Chadburn, A1
Reid, EG1
Ambinder, RF1
Siegel, ER1
Moore, PC1
Rubinstein, PG1
Durand, CM1
Cesarman, E1
Aboulafia, D1
Baiocchi, R1
Ratner, L1
Kaplan, L1
Capoferri, AA1
Lee, JY1
Mitsuyasu, R1
Noy, A1
Richardson, PG1
Holstein, SA1
Schlossman, RL1
Anderson, KC1
Attal, M1
McCarthy, PL1
Hummel, TR1
Wagner, L1
Ahern, C1
Fouladi, M2
Reid, JM2
McGovern, RM1
Ames, MM2
Gilbertson, RJ2
Horton, T1
Ingle, AM2
Weigel, B1
Blaney, SM2
Prebet, T1
Braun, T1
Beyne-Rauzy, O1
Dreyfus, F1
Stammatoullas, A1
Wattel, E1
Ame, S1
Raffoux, E1
Delaunay, J1
Charbonnier, A1
Adès, L1
Fenaux, P1
Vey, N1
Yoo, C1
Ryu, MH1
Na, YS1
Ryoo, BY1
Lee, CW1
Kang, YK1
Park, JR1
Stewart, CF1
Schaiquevich, P1
Sun, J1
Speights, R1
Zwiebel, J1
Adamson, PC1

Clinical Trials (3)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
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 2107 participants (Actual)Interventional2010-10-06Completed
A Phase I Study of SAHA and Temozolomide in Children With Relapsed or Refractory Primary Brain or Spinal Cord Tumors[NCT01076530]Phase 127 participants (Actual)Interventional2010-02-28Completed
A Phase I/II Study of Vorinostat in Combination With Low Dose Ara-C for Patients With Intermediate-2 or High Risk Myelodysplastic Syndromes[NCT00776503]Phase 1/Phase 252 participants (Actual)Interventional2008-05-31Completed
[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

Interventionpercentage of participants (Number)
Phase II: VR-DA-EPOCH75.6
Phase II: DA-R-EPOCH82.2

Overall Survival (OS) (Phase II)

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

Interventionpercentage of participants (Number)
Phase II: VR-DA-EPOCH77.6
Phase II: DA-R-EPOCH86.7

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

Interventionpercentage of participants (Number)
Phase II: VR-DA-EPOCH67.5
Phase II: DA-R-EPOCH76.2

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

InterventionMg per day of Vorinostat (Number)
Phase I: VR-DA-EPOCH300

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

,,
Interventioncells/mm^3 (Median)
End of cycle 2Treatment discontinuation6-month follow-up12-month follow-up
Phase I: VR-CHOP, Dose Level 1-172-81-16128
Phase I: VR-DA-EPOCH, Dose Level 135.5-164.5-56604
Phase I: VR-DA-EPOCH, Dose Level 2-115211275154

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

,,
Interventioncopies per milliliter (Median)
End of cycle 2Treatment discontinuation6-month follow-up12-month follow-up
Phase I: VR-CHOP, Dose Level 128000
Phase I: VR-DA-EPOCH, Dose Level 1-14518-4517-551160
Phase I: VR-DA-EPOCH, Dose Level 2-12.5000

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

,,
Interventioncell/mm^3 (Median)
End of cycle 2Treatment discontinuation6-month follow-up12-month follow-up
Phase I: VR-CHOP, Dose Level 1-218-190-175-84
Phase I: VR-DA-EPOCH, Dose Level 192-3976169
Phase I: VR-DA-EPOCH, Dose Level 2-9-293131

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

,,,
InterventionIU/mL (Median)
End of Cycle 2At treatment discontinuation6-month follow-up12-month follow-up
Phase I: VR-DA-EPOCH, Dose Level 10000
Phase I: VR-DA-EPOCH, Dose Level 2-2436.1-1.92-1.92-1.15
Phase II, DA-R-EPOCH0-0.280-2.7
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

Interventioncopies per 100uL (Median)
12-month follow-up
Phase II: VR-DA-EPOCH0

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

Interventioncopies per 100uL (Median)
At treatment discontinuation6-month follow-up12-month follow-up
Phase II: DA-R-EPOCH000

Changes in Human Immunodeficiency Virus (HIV) Viral Load

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

,
Interventionmedian change in copies per mL (Median)
End of Cycle 2At treatment discontinuation6-month follow-up12-month follow-up
Phase II: DA-R-EPOCH-25-22.5-18-20
Phase II: VR-DA-EPOCH-20-87-200

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

,
Interventionpercentage of participants (Number)
DeathLife-threateningSevereModerateMild
Phase II: DA-R-EPOCH20.028.931.117.80
Phase II: VR-DA-EPOCH28.937.820.08.92.2

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

,
InterventionLiter/hour (Mean)
DoxorubicinEtoposideVincristine
Phase I: VR-DA-EPOCH, Dose Level 178.63.022.4
Phase I: VR-DA-EPOCH, Dose Level 276.02.416.8

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

,,
Interventionpercentage of participants (Number)
Complete responsePartial Response
Phase I: Arm C (VR-CHOP) Dose Level 11000
Phase I: VR-DA-EPOCH, Dose Level 183.316.7
Phase I: VR-DA-EPOCH, Dose Level 283.316.7

Reviews

1 review available for vorinostat and Neutropenia

ArticleYear
Lenalidomide in combination or alone as maintenance therapy following autologous stem cell transplant in patients with multiple myeloma: a review of options for and against.
    Expert opinion on pharmacotherapy, 2017, Volume: 18, Issue:18

    Topics: Clinical Trials as Topic; Drug Therapy, Combination; Hematopoietic Stem Cell Transplantation; Humans

2017

Trials

5 trials available for vorinostat and Neutropenia

ArticleYear
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
A pediatric phase 1 trial of vorinostat and temozolomide in relapsed or refractory primary brain or spinal cord tumors: a Children's Oncology Group phase 1 consortium study.
    Pediatric blood & cancer, 2013, Volume: 60, Issue:9

    Topics: Adolescent; Adult; Antineoplastic Combined Chemotherapy Protocols; Brain Neoplasms; Child; Child, Pr

2013
Combination of vorinostat and low dose cytarabine for patients with azacitidine-refractory/relapsed high risk myelodysplastic syndromes.
    Leukemia research, 2014, Volume: 38, Issue:1

    Topics: Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Azacitidine; Cytarabine; Do

2014
Vorinostat in combination with capecitabine plus cisplatin as a first-line chemotherapy for patients with metastatic or unresectable gastric cancer: phase II study and biomarker analysis.
    British journal of cancer, 2016, May-24, Volume: 114, Issue:11

    Topics: Acetylation; Adenocarcinoma; Adult; Aged; Anorexia; Antineoplastic Combined Chemotherapy Protocols;

2016
Pediatric phase I trial and pharmacokinetic study of vorinostat: a Children's Oncology Group phase I consortium report.
    Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2010, Aug-01, Volume: 28, Issue:22

    Topics: Administration, Oral; Adolescent; Adult; Antineoplastic Agents; Antineoplastic Combined Chemotherapy

2010