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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)

EU Thumbs Up for Bortezomib for Mantle Cell Lymphoma
Source: Medscape Hematology-Oncology Headlines [2014.12.19]
The European authorities have issued a positive opinion for the new indication to bortezomib, already marketed for multiple myeloma.
International Approvals

The Future of Hodgkin Lymphoma -- Brentuximab and Beyond
Source: Medscape Hematology-Oncology Headlines [2014.12.18]
Dr Bruce Cheson and Dr Ann LaCasce highlight data from ASH 2014 on brentuximab vedotin and discuss promising agents for Hodgkin lymphoma, including checkpoint inhibitors nivolumab and pembrolizumab.
Medscape Oncology

Study compares effectiveness of antiviral drugs to prevent hepatitis B virus-related hepatitis among patients receiving chemotherapy for lymphoma
Source: Liver Disease / Hepatitis News From Medical News Today [2014.12.17]
Among patients with lymphoma undergoing a certain type of chemotherapy, receiving the antiviral drug entecavir resulted in a lower incidence of hepatitis B virus (HBV)-related hepatitis and HBV...

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)...

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...

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)

A Study of Escalating Doses of Romidepsin in Association With CHOP in the Treatment of Peripheral T-Cell Lymphomas [Recruiting]
This study is an open label, multicenter study with two phases:

- A dose escalation phase of Romidepsin administered IV at day 1 and 8 or at day 1

without day 8 in combination with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP)administered every 3 weeks for 8 cycles in patients with T-cell lymphoma.

- An expansion phase in order to assess the safety and the efficacy of the association of

the recommended dose of Romidepsin associated with CHOP in a population of patients with T-cell lymphoma.

Topical Romidepsin to Treat Early-Stage Cutaneous T-Cell Lymphoma [Recruiting]
Background:

- Cutaneous T-cell lymphoma (CTCL) is a rare, slow-growing form of skin cancer. The

cancer cells are found in red, scaly patches that may sometimes itch.

- Early-stage CTCL is usually treated with topical therapies, which may lose

effectiveness over time and have adverse effects, such as risk of secondary skin cancers and difficulty of use.

- Romidepsin is an experimental drug that, given through a vein, has improved CTCL in

some patients with later stages of the disease.

- A topical ointment form of romidepsin may be helpful in treating early-stage CTCL.

Objectives:

- To determine the highest tolerated dose of topical romidepsin that can be given to

patients with early-stage CTCL.

- To evaluate the effectiveness of topical romidepsin in patients with early-stage CTCL.

- To determine how the body handles topical romidepsin.

Eligibility:

- Patients 18 of age and older with early-stage CTCL.

Design:

- Study Part 1: Successive groups of 3 patients are treated with increasingly higher

concentrations of topical romidepsin until the highest tolerated dose is found.

- Study Part II: The highest tolerated dose, as determined in Part I, is applied to

larger areas of skin in another group of patients.

- All study participants apply the study medicine to their skin three times a day for 4

weeks.

- During treatment, participants are monitored at weeks 2 and 4 with a history and

physical examination, blood tests, electrocardiogram, skin biopsies and photographs of the skin.

- After stopping treatment, participants return to the clinic at weeks 6 and 8 for blood

tests and to see how the study medication is affecting the body.

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

A Rollover Study for Subjects Who Participated in Other Romidepsin Protocols [Recruiting]
This study is intended to provide access to Romidepsin for subjects who received Romidepsin in other trials sponsored by Gloucester Pharmaceuticals or Celgene Corporation and for subjects whom the investigator feels may benefit from continuing treatment with Romidepsin.

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

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: 2014-12-19

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