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Zolinza (Vorinostat) - Summary

 
 



ZOLINZA SUMMARY

ZOLINZA contains vorinostat, an antineoplastic agent, which is described chemically as N- hydroxy- N'- phenyloctanediamide.

ZOLINZA1 is indicated for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma who have progressive, persistent or recurrent disease on or following two systemic therapies.

ZOLINZA is a histone deacetylase (HDAC) inhibitor indicated for:

  • Treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma (CTCL) who have progressive, persistent or recurrent disease on or following two systemic therapies. (1)

See all Zolinza indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Zolinza (Vorinostat)

Hodgkin lymphoma: Phase 3 AETHERA clinical trial data reported
Source: Clinical Trials / Drug Trials News From Medical News Today [2014.12.10]
Takeda UK Ltd has reported data demonstrating that Hodgkin lymphoma (HL) patients at risk of relapse following an autologous stem cell transplant (ASCT) who received ADCETRIS (brentuximab vedotin)...

Hodgkin lymphoma patients benefit from immunotherapy drugs
Source: Immune System / Vaccines News From Medical News Today [2014.12.10]
In recent years, a number of scientific breakthroughs have led to the development of drugs that unleash the power of the immune system to recognize and attack cancer.

Latest results of investigational cellular therapy in pediatric acute lymphoblastic leukemia, and first results of lymphoma trial
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2014.12.10]
The latest results of clinical trials of more than 125 patients testing an investigational personalized cellular therapy known as CTL019 was presented by a University of Pennsylvania research team at...

Cornerstone Pharmaceuticals commences Phase I clinical trial of CPI-613 for the treatment of B-cell Non-Hodgkin lymphoma
Source: Clinical Trials / Drug Trials News From Medical News Today [2014.12.09]
Cornerstone Pharmaceuticals, Inc., a clinical stage company and leader in the growing field of cancer metabolism-based therapeutics, has announced the initiation of a Phase I clinical trial...

Hodgkin lymphoma responds to immunotherapy
Source: Blood / Hematology News From Medical News Today [2014.12.08]
Two trials show promising results in Hodgkin lymphoma patients treated with immunotherapy drugs that helped their immune system recognize and attack their blood cancer.

more news >>

Published Studies Related to Zolinza (Vorinostat)

A phase I study of vorinostat in combination with idarubicin in relapsed or refractory leukaemia. [2010.07]
Histone deacetylase inhibitors (HDACi) affect chromatin remodelling and modulate the expression of aberrantly silenced genes. HDACi have single-agent clinical activity in haematological malignancies and have synergistic anti-leukaemia activity when combined with anthracyclines in vitro... The combination of vorinostat and idarubicin is generally tolerable and active in patients with advanced leukaemia and should be studied in the front-line setting.

Carboplatin and Paclitaxel in combination with either vorinostat or placebo for first-line therapy of advanced non-small-cell lung cancer. [2010.01.01]
PURPOSE Vorinostat, a histone deacetylase inhibitor, exerts anticancer effects by both histone and nonhistone-mediated mechanisms...

Carboplatin and Paclitaxel in combination with either vorinostat or placebo for first-line therapy of advanced non-small-cell lung cancer. [2010]
PURPOSE Vorinostat, a histone deacetylase inhibitor, exerts anticancer effects by both histone and nonhistone-mediated mechanisms...

A single supratherapeutic dose of vorinostat does not prolong the QTc interval in patients with advanced cancer. [2009.11.15]
CONCLUSIONS: Administration of a single supratherapeutic dose of the histone deacetylase inhibitor vorinostat is not associated with prolongation of the QTc interval. A dedicated QTc study in advanced cancer patients is a robust means for assessing risk for ventricular repolarization prolongation.

Phase 1 clinical trial of the novel proteasome inhibitor marizomib with the histone deacetylase inhibitor vorinostat in patients with melanoma, pancreatic and lung cancer based on in vitro assessments of the combination. [2011.11.12]
Purpose Combining proteasome and histone deacetylase (HDAC) inhibition has been seen to provide synergistic anti-tumor activity, with complementary effects on a number of signaling pathways. The novel bi-cyclic structure of marizomib with its unique proteasome inhibition, toxicology and efficacy profiles, suggested utility in combining it with an HDAC inhibitor such as vorinostat...

more studies >>

Clinical Trials Related to Zolinza (Vorinostat)

SAHA + CHOP in Untreated T-cell Non-Hodgkin's Lymphoma [Recruiting]
The goal of this clinical research study is to find out how well the drug Zolinza (vorinostat) works in combination with the drug combination called CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) to treat patients with untreated T-cell NHL. The safety of these drugs in combination and the best dose of vorinostat when given in combination with CHOP will also be studied.

Objectives:

Primary Objectives:

Phase I:

1. Determine the toxicity profile and the maximum tolerated dose (MTD) of vorinostat when administered in combination with Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP)

Phase II:

2. To evaluate the progression free survival for patients with T-cell NHL receiving the combination of vorinostat and CHOP

Secondary Objectives (Phase I and II):

1. To evaluate the response rate for patients with T-cell NHL receiving the combination of vorinostat and CHOP.

2. To assess overall survival in patients with T-cell NHL treated with the combination of vorinostat and CHOP.

Study of Vorinostat Plus Capecitabine (X) and Cisplatin (P) for 1st Line Treatment of Metastatic or Recurrent Gastric Cancer [Recruiting]
There is scientific rationale for exploring the role of vorinostat, histone deacetylase inhibitor with capecitabine (X) and cisplatin (P), one of standard chemotherapy in patients with advanced gastric cancer. XP is a new standard of care in advanced gastric cancer (AGC) and vorinostat is a novel targeted agent that prevents tumor cell proliferation, survival and angiogenesis through histone deacetylase inhibition.

High-Dose or Low-Dose Vorinostat in Combination With Carboplatin or Paclitaxel in Treating Patients With Advanced Solid Tumors [Recruiting]
This randomized clinical trial is studying high-dose or low-dose vorinostat in combination with carboplatin or paclitaxel to see how well it works in treating patients with advanced solid tumors. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving different doses of vorinostat together with carboplatin or paclitaxel may kill more tumor cells

Study of the Combination of Vorinostat and Radiation Therapy for the Treatment of Patients With Brain Metastases [Recruiting]
Vorinostat in combination with radiation therapy can be administered safely and will be tolerated in patients with brain metastases, while providing an assessment of the anti-tumor activity of this combination.

This is a multi-center, open-label, non-randomized Phase I study in patients with brain metastases. Patients will be administered oral Vorinostat and radiation therapy and will be treated for 3 weeks. Patients will be enrolled in cohorts and will be treated at sequentially rising dose levels of Vorinostat combined with radiation therapy. We will initially enter 3 subjects at each dose. If none of the three experiences a dose-limiting toxicity we will proceed to the next dose. If one of the three experiences that level of toxicity, we will accrue 3 more subjects at that dose. If at any time there are two or more dose-limiting toxicities (in the 3-6 subjects) on a given dose, we will drop down to a lower dose. Dose escalation will continue until the MTD of Vorinostat and radiation therapy is established. The MTD will then be one dose below the DLT occurring in at least 1 out of 3 subjects (2 out of 6 patients).

A Pilot Study of Oral Vorinostat Plus Oral Eltrombopag Support in Patients With Lymphoma (VEIL) [Recruiting]
Vorinostat is a drug (Histone Deacetylase Inhibitor [HDACi]) administered orally that has been approved in United States for the patients with cutaneous Tcell lymphoma (CTCL) who have progressive, persistent or recurrent disease on or following two systemic therapies.

In the early period of treatment with vorinostat, some patients may experience low platelet counts. Therefore this study will be examining the combination of these two medications (Vorinostat and eltrombopag) to assess if eltrombopag can overcome the low platelets during treatment with vorinostat.

Eltrombopag is a drug administered orally designed to mimic the protein thrombopoietin, which causes the body to make more platelets. Eltrombopag has been registered in Australia and approved overseas to treat patients with chronic ITP (Immune Thrombocytopenia Purpura) a disease where patients destroy their own platelets very rapidly and thus develop low platelet count) but it is not registered and it is not yet known whether eltrombopag can increase platelet counts in patients treated with the HDACi.

The aim of this project is to test whether Vorinostat and eltrombopag can be safely combined, and to test whether they are effective in participants with T-cell lymphoma involving the skin or patients with relapsed/refractory follicular lymphoma (FL), marginal zone lymphoma (MZL), or mantle cell lymphoma (MCL)

A total of 25 people with Cutaneous T cell lymphoma/ CTCL, marginal zone lymphoma, follicular lymphoma or mantle cell lymphoma will be recruited in this study.

more trials >>

Reports of Suspected Zolinza (Vorinostat) Side Effects

Pyrexia (15)Decreased Appetite (12)Dehydration (10)Pneumonitis (9)Pleural Effusion (8)Febrile Neutropenia (8)Sepsis (8)Disease Progression (6)White Blood Cell Count Decreased (6)Renal Failure (6)more >>


Page last updated: 2014-12-10

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