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)

NEWS HIGHLIGHTS

Media Articles Related to Zolinza (Vorinostat)

Co-Founder Of Microsoft Diagnosed With Non-Hodgkin's Lymphoma
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2009.11.17]
Paul Allen who co-founded the computer giant Microsoft with Bill Gates in the 1970s has been diagnosed with Non-Hodgkin's Lymphoma, 25 years after surviving Hodgkin's lymphoma. The news was announced in a memo to the staff of Allen's company Vulcan, by CEO Jody Allen, who is also Paul Allen's sister. A copy of the memo was also sent to the media.

FDA Approves New Drug For Rare Cancer Cutaneous T-Cell Lymphoma
Source: Blood / Hematology News From Medical News Today [2009.11.12]
The US Food and Drug Administration (FDA) has approved a new drug for treating patients with the rare white blood cell cancer Cutaneous T-cell Lymphoma (CTCL); the drug Istodax (romidepsin) is injectable and is marketed by Gloucester Pharmaceuticals Inc of Cambridge, Massachusetts. Every year, about 1,500 Americans are newly diagnosed with CTCL, a type of non-Hodgkin's lymphoma.

Istodax Approved for Cutaneous T-Cell Lymphoma
Source: MedicineNet Non-Hodgkins Lymphomas Specialty [2009.11.09]
Title: Istodax Approved for Cutaneous T-Cell Lymphoma
Category: Health News
Created: 11/6/2009 4:10:00 PM
Last Editorial Review: 11/9/2009

FDA Approves Gloucester Pharmaceuticals' ISTODAX(R) For Patients With Cutaneous T-cell Lymphoma
Source: Blood / Hematology News From Medical News Today [2009.11.06]
Gloucester Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) approved ISTODAX® (romidepsin) for the treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy. The approval of ISTODAX was based on objective disease response defined as the proportion of patients with confirmed complete response or partial response.

Approved Lymphoma Drug Shows Promise In Early Tests Against Bone Cancer
Source: Bones / Orthopaedics News From Medical News Today [2009.11.06]
A drug already approved for the treatment of lymphoma may also slow the growth of the most deadly bone cancer in children and teens, according to an early-stage study published online in the International Journal of Cancer. The study drug, Bortezomib, was found to be effective against bone cancer in human cancer cell studies and in mice.

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Published Studies Related to Zolinza (Vorinostat)

Phase I trial of vorinostat and doxorubicin in solid tumours: histone deacetylase 2 expression as a predictive marker. [2009.10.06]
BACKGROUND: Histone deacetylase inhibitors (HDACi) can sensitise cancer cells to topoisomerase inhibitors by increasing their access and binding to DNA... CONCLUSION: These findings suggest that vorinostat can be combined with weekly doxorubicin in this schedule at a dose of 800 mg day(-1). The HDAC2 expression may be a marker predictive of HDAC inhibition. Antitumor activity of this regimen in breast cancer, prostate cancer, and melanoma seems interesting.

A phase 2 study of vorinostat in acute myeloid leukemia. [2009.10]
BACKGROUND: This two-stage, multi-institutional, randomized phase 2 trial assessed the toxicity and response rate associated with two treatment schedules of the histone deacetylase inhibitor, vorinostat (suberoylanilide hydroxamic acid; SAHA) in patients with relapsed acute myeloid leukemia and in selected untreated patients with high-risk acute myeloid leukemia... CONCLUSIONS: Vorinostat monotherapy demonstrated minimal activity in this group of patients with acute myeloid leukemia. Therapy was discontinued in many patients before the planned four cycles had been administered, either because of failure of vorinostat to control the leukocyte count or patients' and physicians' preference. Future studies of vorinostat in acute myeloid leukemia should focus on combinations with other drugs with which it might interact pharmacodynamically. ClinicalTrials.gov Identifier: NCT00305773.

Potential efficacy of the oral histone deacetylase inhibitor vorinostat in a phase I trial in follicular and mantle cell lymphoma. [2009.09.10]
Vorinostat (suberoylanilide hydroxamic acid, SAHA, Zolinza) is a histone deacetylase inhibitor with clinical activity in cutaneous T-cell lymphoma (CTCL). A phase I trial of oral vorinostat was conducted in Japanese patients with malignant lymphoma... These data suggest that further investigations of vorinostat in non-Hodgkin lymphoma, focusing on FL and MCL, are warranted.

Phase I and pharmacokinetic study of vorinostat (suberoylanilide hydroxamic acid) in Japanese patients with solid tumors. [2009.09]
Vorinostat (suberoylanilide hydroxamic acid), a potent, oral histone deacetylase inhibitor, has demonstrated clinical activity in non-Japanese patients with various hematological and solid tumors. We sought to determine the maximum tolerated dose and a recommended phase II dose for 18 Japanese patients with solid tumors (median age, 58 years; range, 25-72 years) who failed standard therapy...

Vorinostat in advanced prostate cancer patients progressing on prior chemotherapy (National Cancer Institute Trial 6862): trial results and interleukin-6 analysis: A study by the Department of Defense Prostate Cancer Clinical Trial Consortium and University of Chicago Phase 2 Consortium. [2009.08.26]
BACKGROUND:: This phase 2 trial was designed to evaluate the efficacy of vorinostat in chemotherapy-pretreated patients with metastatic castration-resistant prostate cancer... CONCLUSIONS:: Vorinostat at this dose was associated with significant toxicities limiting efficacy assessment in this patient population. The significant association between IL-6 levels and removal from the study for toxicities warrants further investigation. Cancer 2009. (c) 2009 American Cancer Society.

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Clinical Trials Related to Zolinza (Vorinostat)

A Phase I/II Clinical Trial of an Experimental Cancer Drug in Combination With an FDA Approved Cancer Drug for Patients With Relapsed/Refractory Non-Small-Cell Lung Cancer [Terminated]
The reason for this study will be to find the safest maximum tolerated dose of oral vorinostat in combination with erlotinib (Tarceva (TM)) that can be given to patients with lung cancer who have relapsed or failed other therapy for the disease. Once the safest maximum tolerated dose of vorinostat is determined, patients enrolled in the clinical trial will continue vorinostat and erlotinib for up to 8 months. Safety and effectiveness will also be evaluated.

Suberoylanilide Hydroxamic Acid in Advanced Solid Tumors [Active, not recruiting]
The purpose of this investigational study is to determine the safety and tolerability of oral suberoylanilide hydroxamic acid when administered in combination with standard doses of pemetrexed and cisplatin for the treatment of advanced solid tumors.

Phase I Study of Vorinostat in Combination With Docetaxel in Patients With Advanced and Relapsed Solid Malignancies. [Recruiting]
Vorinostat (Suberoylanilide Hydroxamic Acid; NSC 701852) is a drug that inhibits an enzyme that plays a key role in the regulation of cell survival, growth, and eventual cell death, all of which play a role in cancer. As a result, this drug has the potential to affect a tumor's ability to survive. Vorinostat is the most potent drug of its kind that is currently under investigation in clinical trials. The primary objective of this study is to define the maximum safest dose of vorinostat in combination with a standard chemotherapy agent, docetaxel, in patients with advanced and relapsed lung, bladder, or prostate cancer.

Vorinostat, Carboplatin and Gemcitabine Plus Vorinostat Maintenance in Women With Recurrent, Platinum-Sensitive Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer [Recruiting]
The purpose of this research study is to: 1) Determine the highest dose of the drug vorinostat that can be given safely in combination with carboplatin and gemcitabine and 2) determine how long the participant's cancer will respond to the combination of vorinostat, carboplatin and gemcitabine. Vorinostat is a type of drug called a histone deacetylase inhibitor (HDAC inhibitor). HDAC inhibitors interact with chromosomes in the cancer cell and cause cancer cells to stop growing. Vorinostat has shown a decrease in the amount of ovarian cancer cells growing in the laboratory and also may enhance the anti-cancer effects of carboplatin.

A Crossover Study to Assess the Effects of Vorinostat (MK0683, SAHA) in Patients With Advanced Cancer [Recruiting]
A 2-period, crossover study to assess the effects of MK0683 (vorinostat) on the QTc interval in patients with relapsed or refractory advanced cancer.

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