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Istodax (Romidepsin) - 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 >>


Media Articles Related to Istodax (Romidepsin)

Follow-up PET/CT more than 95 percent sensitive for non-Hodgkin lymphoma
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2015.06.09]
Non-Hodgkin lymphoma (NHL), a potentially devastating cancer of the blood and immune system, can range from relatively easy to treat to very aggressive.

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

Non-Hodgkin's Lymphoma
Source: MedicineNet Biological Therapy Specialty [2015.04.01]
Title: Non-Hodgkin's Lymphoma
Category: Diseases and Conditions
Created: 12/31/1997 12:00:00 AM
Last Editorial Review: 4/1/2015 12:00:00 AM

Breakthrough test clearly distinguishes Burkitt lymphoma from DLBCL
Source: The Doctors Lounge - Oncology
A gene expression signature clearly distinguishes Burkitt lymphoma from DLBCL, a critical distinction in diagnosis.

Mount Sinai researchers to present key cancer trial data at ASCO
Source: Prostate / Prostate Cancer News From Medical News Today [2015.06.02]
Mount Sinai Health System faculty will be presenting research updates on a lymphoma vaccine clinical trial, the best dosing for a drug against metastatic cancer, and new treatment strategies in...

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]

- 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.


- 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.


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


- 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


- 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: 2015-06-09

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