Istodax

CTAGE1 protein, human
Treatment
13 Active Studies for Istodax

What is Istodax

RomidepsinThe Generic name of this drug
Treatment SummaryRomidepsin is a medication used to treat cutaneous T-cell lymphoma (CTCL) and peripheral T-cell lymphoma (PTCL) that have not responded to other treatments. It was approved by the FDA in 2009 and works by blocking certain enzymes that cause cancer cells to spread. While it has been shown to improve response rates, its effects on overall survival have yet to be proven.
Istodaxis the brand name
image of different drug pills on a surface
Istodax Overview & Background
Brand Name
Generic Name
First FDA Approval
How many FDA approvals?
Istodax
Romidepsin
2009
8

Effectiveness

How Istodax works in the bodyRomidepsin is a drug that targets cancer cells by inhibiting a specific enzyme, called HDAC. In some cancers, the levels of HDAC are higher than normal, which can turn off important regulatory genes and cause the growth of tumors. Romidepsin works by blocking HDAC, restoring normal gene expression and causing the cancer cells to stop growing and die.

When to interrupt dosage

The prescribed dosage of Istodax is contingent upon the diagnosed state. The quantity likewise fluctuates, in line with the method of administration cited in the table beneath.
Condition
Dosage
Administration
CTAGE1 protein, human
, 10.0 mg, 10.0 mg/mL, 5.0 mg/mL
, Kit, Intravenous, Kit; Powder, for solution, Kit; Powder, for solution - Intravenous, Kit - Intravenous, Injection, solution, concentrate - Intravenous, Injection, solution, concentrate

Warnings

There are 20 known major drug interactions with Istodax.
Common Istodax Drug Interactions
Drug Name
Risk Level
Description
Artemether
Major
The risk or severity of QTc prolongation can be increased when Romidepsin is combined with Artemether.
Asenapine
Major
The risk or severity of QTc prolongation can be increased when Romidepsin is combined with Asenapine.
Axitinib
Major
The metabolism of Axitinib can be decreased when combined with Romidepsin.
Cabazitaxel
Major
The metabolism of Cabazitaxel can be decreased when combined with Romidepsin.
Clonidine
Major
The metabolism of Clonidine can be decreased when combined with Romidepsin.
Istodax Toxicity & Overdose RiskRomidepsin is not recommended during pregnancy due to an unknown risk factor. If a nursing mother takes this drug, she should consider stopping breastfeeding or the drug, depending on how important the treatment is for her. Many patients who take romidepsin also experience nausea, vomiting, or loss of appetite.
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Istodax Novel Uses: Which Conditions Have a Clinical Trial Featuring Istodax?

No current clinical trials are investigating the utility of Istodax in treating Lymphoma, Cutaneous T-Cell Disorders.
Condition
Clinical Trials
Trial Phases
CTAGE1 protein, human
13 Actively Recruiting
Phase 1, Not Applicable, Phase 2, Early Phase 1, Phase 3

Istodax Reviews: What are patients saying about Istodax?

3Patient Review
5/16/2011
Istodax for Cutaneous T-Cell Lymphoma
The drug infusion itself only takes 4 and 1/2 hours, but there's also the approximately 1/2 hour infusion of an anti-nausea agent first. Then there is the 1 to 2 hour wait for the blood draw results. Somehow this neeeds to be streamlined.
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Patient Q&A Section about istodax

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is istodax chemo?

"It is classified as a "topoisomerase II inhibitor." Istodax is a chemotherapy drug that inhibits topoisomerase II."

Answered by AI

What is istodax used for?

"ISTODAX is a prescription medicine used to treat people with a type of cancer called cutaneous T-cell lymphoma (CTCL) or peripheral T-cell lymphoma (PTCL) after at least one other type of medicine by mouth or injection has been tried. It is not known if ISTODAX is effective in children under the age of 18."

Answered by AI

Why was romidepsin taken off the market?

"Bristol Myers Squibb announced today that it is withdrawing romidepsin (Istodax) as a treatment option for patients with relapsed/refractory peripheral T-cell lymphoma (PTCL) in the United States. This decision is based on the lack of beneficial effects of romidepsin identified in the confirmatory phase 3 Ro-CHOP trial (NCT01796002)."

Answered by AI

How is istodax administered?

"Romidepsin is indicated as a treatment for cutaneous T-cell lymphoma for patients who have received at least one prior systemic therapy. The recommended dose is 14 mg/m2 administered intravenously over a 4-hour period on days 1, 8 and 15 of a 28-day cycle."

Answered by AI

Clinical Trials for Istodax

Image of National Institutes of Health Clinical Center in Bethesda, United States.

CCR4 CAR T Cells for T-Cell Lymphoma

18 - 120
All Sexes
Bethesda, MD
Background: Chemokine receptor 4 (CCR4) is a protein that is found on the surface of certain T-cell lymphoma cells and is common in mature T-cell cancers. White blood cells can be changed with molecules called anti-CCR4 to express a chimeric antigen receptors (CAR), which is a molecule that directs a white blood cell to attack other cells. The CAR in this study attacks the CCR4 protein found on your T-cell lymphoma. This type if therapy is called gene therapy. Gene therapy involves a person s own white blood cells modified to target cancer cells. More research is needed to find out if gene therapy can treat T-cell cancers and do it safely. Objective: To test safety of giving people with certain mature T-cell lymphomas their own white blood cells modified with anti-CCR-4 CAR. Eligibility: People aged 18 and older with certain mature T-cell lymphomas that have not responded to or have come back after treatment. They must have a T-cell lymphoma that has CCR4 on the surface of the cancer cells. Design: Participants will be screened. They will have a medical history and physical exam. Tests of blood, urine, and heart and lung function will be done. Participants will have tests: Computed tomography (CT), positron emission tomography (PET), and magnetic resonance imaging scans: They will lie on a table that slides into a donut-shaped machine or a tube. Pictures of the inside of the body will be taken. Before the PET scan, they will get an injection of radioactive fluid in a vein in the arm. Before the MRI, they may get a contrast dye injected through a vein (IV) in the arm. A biopsy of the tumor may be taken. A bone marrow sample may be taken from the hip: The area will be numbed and a large needle inserted through the skin. Leukapheresis will be done to obtain T-cells that will be genetically modified to express anti-CCR4 CARs on T-cells: Blood is drawn through an IV in one arm, circulated through a machine, and then returned through an IV in the other arm. Chemotherapy drugs will be given in an IV to prepare the body to accept the modified CAR T cells. The modified cells will be given in an IV. Participants will be followed for 15 years: This will require blood tests over the first 1-2 years followed by yearly visits and possibly telehealth updates....
Phase 1
Recruiting
National Institutes of Health Clinical CenterSamuel Y Ng, M.D.
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Pembrolizumab + Mogamulizumab for Cutaneous T-Cell Lymphoma

18+
All Sexes
Ann Arbor, MI
This is an open-label, single-arm, multicenter, phase II study combining pembrolizumab and mogamulizumab in patients with advanced-stage, relapsed or refractory CTCL Each cycle will equal 6 weeks. Pembrolizumab will be administered on Day 1 of each cycle. Mogamulizumab will be administered on Day 1, 8, 15, and 22 of Cycle 1. For Cycle 2 and subsequent cycles, mogamulizumab will be administered on Day 1, 15 and 29 of each cycle. Subjects will undergo a response assessment prior to Cycle 3 and every 2 cycles thereafter. Subjects will continue study treatment until documented progression, unacceptable toxicity, or any other condition for discontinuation is met in protocol. A maximum of 2 years of study treatment may be administered. If a subject achieves a complete response (CR) per mSWAT criteria after 3 months of study treatment (2 cycles), they will continue study therapy for an additional 6 months (4 cycles). If a confirmed and persistent CR is met, they may discontinue study treatment and enter an observation period in protocol. Repeat disease evaluation is required prior to study therapy discontinuation. Subjects who progress during the observation period may be eligible for up to an additional 9 cycles (1 year) of pembrolizumab and mogamulizumab.
Phase 2
Recruiting
University of Michigan Comprehensive Cancer CenterRyan WilcoxMerck Sharp & Dohme LLC
Have you considered Istodax clinical trials? We made a collection of clinical trials featuring Istodax, we think they might fit your search criteria.Go to Trials
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RAdR Regimen for T-Cell Lymphoma

18+
All Sexes
Bethesda, MD
Background: Mature T-cell malignancies (TCMs) are a rare group of cancers that usually do not have effective treatments or cures. Because of this, participants with TCMs often relapse and have a poor overall prognosis. This trial is testing if combining several drugs against TCMs can be a more effective. Primary Objective: To test if the combination of romidepsin, CC-486 (5-azacitidine), dexamethasone, and lenalidomide (RAdR) can be given safely to participants with relapsed or treatment refractory TCM. Other (Secondary) Objective: Measure the activity of this combination treatment. Eligibility: People age 18 and older who have a failed or relapsed after standard treatments for mature TCMs. Design: Participants will be screened for eligibility by performing the following tests or procedures: Physical exam Medical history Medicine review Blood and urine tests Symptom review Bone marrow examination Total Body imaging scans or x-rays Tumor biopsy Participants will have blood tests during treatment to make sure their blood cell counts are okay. Romidepsin is infused through an intravenous (IV) placed in one of the veins usually in the arm. Lenalidomide, dexamethasone, and CC-486 (5-azacitidine) are pills or capsules taken by mouth. Participants are asked to keep a diary of when they take their pills to make sure they are taking these medicines properly. Participants will have tumor imaging scans after every 2nd cycle (or 6 weeks) to check if the treatment is working. If the doctors are concerned the cancer has spread to the brain and/or spine, they will have scans of the area(s) and a sampling of the fluid around the brain/spine which is obtained through a small needle inserted into the lower part of the back for a short time to collect the fluid. This procedure is called a spinal tap or lumbar puncture. Participants who have tumor in their skin will have repeat exams of their skin and sometimes photographs taken of these areas to see if the treatment is working. Participants will also be asked to give blood, saliva, and sometimes have optional biopsies of their tumor where these tests are done for research purposes. After they have completed the protocol treatment (6 cycles), they will be asked to return to clinic 30 days after treatment has ended, then every other month (or 60 days) for the first 6 months, then every 3 months (90 days) for 2 years, and then every 6 months for years 2 to 4 after completing treatment. After 4.5 years, they will be seen once a year.
Phase 1
Waitlist Available
National Institutes of Health Clinical CenterMark J Roschewski, M.D.
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