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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)

Early results show response to new drug in patients with lymphomas and advanced solid tumours
Source: Cancer / Oncology News From Medical News Today [2014.11.21]
Patients with B-cell Non-Hodgkin lymphomas and advanced solid tumours have responded to a new drug that is being tested for the first time in humans in a phase I clinical trial.

In mouse model severe inflammations triggered by potential treatment approach for lymphomas
Source: Immune System / Vaccines News From Medical News Today [2014.11.20]
The Malt1 protein is one of the most important control centers in human immune cells and a real all-rounder. Genetic defects in it can lead to the development of lymphatic cancer (lymphoma).

Many older people have mutations linked to leukemia, lymphoma in their blood cells
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2014.10.21]
At least 2 percent of people over age 40 and 5 percent of people over 70 have mutations linked to leukemia and lymphoma in their blood cells, according to new research at Washington University...

FDA approves VELCADE® (bortezomib) for injection for previously untreated patients with mantle cell lymphoma
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2014.10.13]
Millennium: The Takeda Oncology Company with its parent company, Takeda Pharmaceutical Company Limited, has announced that the U.S.

Canine lymphoma: new hope for beloved family pets
Source: Veterinary News From Medical News Today [2014.09.23]
Nearly one out of four dogs will develop cancer in their lifetime and 20 per cent of those will be lymphoma cases.

more news >>

Published Studies Related to Istodax (Romidepsin)

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...

Inhibition of transcription, expression, and secretion of the vascular epithelial growth factor in human epithelial endometriotic cells by romidepsin. [2011.04]
OBJECTIVE: To investigate whether the histone deacetylase (HDAC) inhibitor romidepsin down-regulates VEGF (vascular endothelial growth factor) gene expression and abrogates VEGF protein secretion in human epithelial endometriotic cells. DESIGN: In vitro study with human immortalized epithelial endometriotic cells.

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.

Romidepsin in Treating Patients With Lymphoma, Chronic Lymphocytic Leukemia, or Solid Tumors With Liver Dysfunction [Recruiting]
This research is being done to study the safety of the anti-cancer drug romidepsin at different dose levels in patients with cancer who have different degrees of abnormal liver function. Romidepsin works by entering cancer cells and blocking the activity of proteins that are important for the cancer's growth and survival

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 Peripheral T-Cell Lymphoma (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.

Dose-Escalation Trial of Carfilzomib With and Without Romidepsin in Cutaneous T-Cell Lymphoma [Recruiting]
This randomized phase I trial studies the side effects and the best dose of carfilzomib when given together with or without romidepsin in treating patients with stage IA-IVB cutaneous T-cell lymphoma. Carfilzomib and romidepsin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving carfilzomib alone is more effective than when given together with romidepsin.

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.

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: 2014-11-21

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