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Istodax (Romidepsin) - Summary

 
 



ISTODAX SUMMARY

Romidepsin, a histone deacetylase (HDAC) inhibitor, is a bicyclic depsipeptide.

ISTODAX is indicated for treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy.


See all Istodax indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Istodax (Romidepsin)

Optimizing effectiveness of CAR T cell therapy in lymphoma highlighted in special nordic issue
Source: Immune System / Vaccines News From Medical News Today [2015.08.25]
Chimeric antigen receptor (CAR) T cells, which can specifically recognize and target tumor cells, have resulted in complete responses in patients with leukemia, and although equally promising for...

FDA approves Adcetris for high risk Hodgkin Lymphoma patients
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2015.08.20]
Seattle Genetics, Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved ADCETRIS (brentuximab vedotin) for the treatment of patients with classical Hodgkin lymphoma (HL)...

Topical drug leads to complete remission for some patients with rare skin lymphoma
Source: Dermatology News From Medical News Today [2015.08.07]
Researchers reveal how a topical drug called resiquimod led to total remission for some patients with a cutaneous T cell lymphoma - a rare skin lymphoma.

Topical gel proves safe, effective treatment for patients with skin T cell lymphoma
Source: Dermatology News From Medical News Today [2015.08.07]
Phase 1 trial first to show topical therapy causes systemic immune response, and may eradicate cancerous cells from treated and untreated lesionsResults of a phase one trial show that an...

Hodgkin's Lymphoma Survivors Face Higher Long-Term Heart Risks
Source: MedicineNet Hodgkins Disease Specialty [2015.04.28]
Title: Hodgkin's Lymphoma Survivors Face Higher Long-Term Heart Risks
Category: Health News
Created: 4/27/2015 12:00:00 AM
Last Editorial Review: 4/28/2015 12:00:00 AM

more news >>

Published Studies Related to Istodax (Romidepsin)

Romidepsin for peripheral T-cell lymphoma. [2013]
Peripheral T-cell lymphoma (PTCL) is comprised of a rare heterogeneous group of diseases with diverse clinical presentations; however outcomes associated with conventional chemotherapy are generally poor in the majority of patients. Newer approaches, which include dose-intensification and agents with novel mechanisms of action, are needed to improve outcomes in this group of patients...

Romidepsin: a novel histone deacetylase inhibitor for cancer. [2011.08]
Introduction: Romidepsin is a novel histone deacetylase (HDAC) inhibitor, with a recent approval for treatment of cutaneous T-cell lymphoma (CTCL).Future directions include expanded indications in T-cell lymphomas as well as novel combinations with other HDAC inhibitors and other therapeutic agents.

Romidepsin (Istodax, NSC 630176, FR901228, FK228, depsipeptide): a natural product recently approved for cutaneous T-cell lymphoma. [2011.08]
Romidepsin (Istodax), a selective inhibitor of histone deacetylases (HDACs), was approved for the treatment of cutaneous T-cell lymphoma in November 2009 by the US Food and Drug Administration. This unique natural product was discovered from cultures of Chromobacterium violaceum, a Gram-negative bacterium isolated from a Japanese soil sample...

Phase 2 trial of romidepsin in patients with peripheral T-cell lymphoma. [2011.06.02]
Romidepsin (depsipeptide or FK228) is a histone deacetylase inhibitor, one of a new class of agents active in T-cell lymphoma. A phase 2 trial was conducted in cutaneous (CTCL) and peripheral (PTCL) T-cell lymphoma... The histone deacetylase inhibitor romidepsin has single agent clinical activity associated with durable responses in patients with relapsed PTCL.

A phase I/II trial of the histone deacetylase inhibitor romidepsin for adults with recurrent malignant glioma: North American Brain Tumor Consortium Study 03-03. [2011.05]
Romidepsin, a potent histone deacetylase inhibitor, has shown activity in preclinical glioma models. The primary objectives of this trial were to determine the pharmacokinetics of romidepsin in patients with recurrent glioma on enzyme-inducing antiepileptic drugs (EIAEDs) and to evaluate the antitumor efficacy of romidepsin in patients with recurrent glioblastoma who were not receiving EIAEDs...

more studies >>

Clinical Trials Related to Istodax (Romidepsin)

Romidepsin Maintenance After Allogeneic Stem Cell Transplantation [Not yet recruiting]
The goal of this clinical research study is to learn if giving romidepsin before and after a stem cell transplant in combination with fludarabine and busulfan can help to control leukemia or lymphoma. Researchers also want to learn the highest tolerable dose of romidepsin that can be given with this combination. The safety of this combination and the safety of giving romidepsin after a stem cell transplant will also be studied.

Phase I Study of Romidepsin Plus ICE for Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma [Recruiting]
The goal of this clinical research study is find the highest tolerable dose of romidepsin that can be given in combination with ifosfamide, carboplatin, etoposide (ICE) to patients with PTCL. The safety of this drug combination will also be studied. Romidepsin is designed to stop the growth of cancer cells and block new blood vessels from forming around the cancer cells. This may cause the cancer cells to die. Ifosfamide and etoposide are designed to slow or stop the growth of cancer cells. Carboplatin is designed to interfere with the growth of cancer cells by stopping cell division, which may cause the cells to die.

Influence of Ketoconazole on the Pharmacokinetics of Romidepsin in Patients With Advanced Cancer [Completed]

Influence of Rifampin on the Pharmacokinetics of Romidepsin in Patients With Advanced Cancer [Completed]

Phase I Dose-finding and Preliminary Efficacy Study of the Istodax® in Combination With Doxil® for the Treatment of Adults With Relapsed or Refractory Cutaneous T-cell Lymphoma [Recruiting]
This a multi-center, single arm, open-label, Phase I dose-finding and preliminary efficacy study of the combination of the histone deacetylase inhibitor romidepsin (Istodax®) in combination with doxorubicin HCl liposomal (Doxil®) for adult patients with relapsed or refractory cutaneous T-cell lymphoma after at least 2 lines of skin-directed therapy or one prior line of systemic therapy. Patients will be treated with Doxil 20mg/m2 on day 1 and romidepsin 8-14mg/m2 on days 1, 8 and 15, every 28 days, until 2 cycles beyond the best response, 8 cycles, disease progression or intolerability whichever comes first. Importanly, doxil is administered prior to romidepsin on day1 of each cycle. Patients will be followed until disease progression or death whichever comes first.

more trials >>

Reports of Suspected Istodax (Romidepsin) Side Effects

Pyrexia (12)Thrombocytopenia (7)Decreased Appetite (6)Fatigue (5)Pulmonary Oedema (5)Infusion Site Extravasation (4)Peripheral Sensory Neuropathy (4)Death (4)General Physical Health Deterioration (4)Febrile Neutropenia (4)more >>


Page last updated: 2015-08-25

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