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Histone Deacetylase Inhibitor
Romidepsin for Cancer and Chronic Lymphocytic Leukemia with Liver Dysfunction
Phase 1
Waitlist Available
Led By Roisin M Connolly
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients who have received prior romidepsin use are eligible
Patients must have histologically or cytologically confirmed lymphoma, chronic lymphocytic lymphoma (CLL) or solid tumor, and be refractory to standard therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0, 1, 2, 3, 4, 4.25, 4.5, 5, 6, 8, 10, 24, and 48 hours after initiation of the infusion on day 1
Awards & highlights
Study Summary
This trial studies the side effects and best dose of romidepsin in treating patients with lymphoma, chronic lymphocytic leukemia, or solid tumors.
Who is the study for?
This trial is for patients with lymphoma, chronic lymphocytic leukemia, or solid tumors who also have liver dysfunction. They must be relatively active (able to care for themselves), not have had certain cancers that didn't respond to previous phase 2 studies unless they are in moderate/severe liver dysfunction groups, and meet specific health criteria including blood counts and kidney function. Pregnant women and those with significant heart disease or on certain medications like warfarin cannot join.Check my eligibility
What is being tested?
The trial is testing the effects of a drug called Romidepsin on various types of cancer in patients with liver problems. It aims to find the safest dose that can manage cancer growth by blocking proteins essential for cancer cell survival.See study design
What are the potential side effects?
Romidepsin may cause side effects such as nausea, fatigue, infections due to low blood cell counts, changes in sense of taste, coughing, shortness of breath, and potential heart issues like irregular heartbeat.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have previously been treated with romidepsin.
Select...
My cancer does not respond to standard treatments anymore.
Select...
I have a liver tumor, high alpha-fetoprotein levels, and hepatitis, indicating liver cancer.
Select...
I can take care of myself but might not be able to do heavy physical work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose-limiting toxicity of romidepsin in groups of patients with varying degree of hepatic dysfunction according to the National Cancer Institute Common Toxicity Criteria for Adverse Events version 5.0
Maximum tolerated dose of romidepsin in groups of patients with varying degree of hepatic dysfunction according to the National Cancer Institute Common Toxicity Criteria for Adverse Events version 5.0
Pharmacokinetic (PK) profile of romidepsin in patients with varying degrees of hepatic dysfunction using liquid chromatography-electrospray ionization tandem mass spectrometric method
Secondary outcome measures
Antitumor activity assessed using Response Evaluation Criteria in Solid Tumors and the International Workshop Lymphoma Response Criteria
Child-Pugh classification of hepatic dysfunction
Side effects data
From 2021 Phase 1 & 2 trial • 24 Patients • NCT0301035865%
Infusion related reaction
59%
Neutrophil count decreased
41%
Upper respiratory infection
29%
Aspartate aminotransferase increased
29%
Platelet count decreased
24%
Alanine aminotransferase increased
18%
Sinusitis
18%
Urinary tract infection
12%
Tooth infection
6%
Bronchial infection
6%
Acute Coronary Syndrome
6%
Febrile neutropenia
6%
Sepsis
6%
Infections and infestations - Other, specify
6%
Nail infection
6%
Rhinitis infective
6%
Tumor lysis syndrome
6%
Infusion Related Reaction
6%
Wound infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 2 and MTD (800 mg Entospletinib Daily)
Phase 1, Dose 1 (400 mg Entospletinib Daily)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (romidepsin)Experimental Treatment2 Interventions
Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Romidepsin
2011
Completed Phase 2
~790
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,116 Total Patients Enrolled
Celgene CorporationIndustry Sponsor
444 Previous Clinical Trials
58,199 Total Patients Enrolled
Roisin M ConnollyPrincipal InvestigatorJHU Sidney Kimmel Comprehensive Cancer Center LAO
3 Previous Clinical Trials
700 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have prostate, renal cell, neuroendocrine, lung, colorectal cancers, soft tissue sarcomas, glioma, or thyroid cancer.I have previously been treated with romidepsin.You need to have a certain level of red blood cells, white blood cells, platelets, and a substance called creatinine in your blood.I haven't had major surgery or antibody therapies recently.I have relapsed or refractory PTCL or CTCL without time restrictions on my last treatment.I am not taking any medications that affect heart rhythm.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.My cancer does not respond to standard treatments anymore.I have a liver tumor, high alpha-fetoprotein levels, and hepatitis, indicating liver cancer.I do not have prostate, renal, neuroendocrine, lung, colorectal cancers, soft tissue sarcomas, glioma, or thyroid cancer.I have a specific type of cancer and meet certain conditions for the study.My liver isn't working normally, but I can still join the study.My brain metastases are stable and meet treatment guidelines.My medications have been reviewed for interactions with romidepsin.I stopped taking certain medications 7 days before starting romidepsin.I have a stent placed for biliary obstruction.I agree to use birth control during the study.I do not have serious heart problems or recent heart attacks.I am not taking medications like rosiglitazone or pioglitazone.You have had allergic reactions to drugs similar to romidepsin.People who have HIV must meet certain requirements.I can take care of myself but might not be able to do heavy physical work.I am not taking Warfarin.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (romidepsin)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the opportunity for participation in this experiment available to patients at present?
"As shown on clinicaltrials.gov, this trial is not currently accepting patients; it was posted to the website on June 12th 2012 and most recently updated October 19th 2022. However, there are 15207 other studies actively recruiting right now."
Answered by AI
Could you explain the potential risks associated with Pharmacological Study for participants?
"As Phase 1 trials usually only provide limited evidence for the safety and efficacy of a drug, our team at Power has assigned Pharmacological Study a score of 1 on their risk-scale."
Answered by AI
Are there numerous institutions administering this clinical research in Canada?
"At present, 12 medical centres across the USA are taking part in this research study. Popular locations include Toronto, Sacramento and Detroit with a further 9 sites available. Choosing to take part at the closest centre can help alleviate some of the burdens associated with travelling for treatment."
Answered by AI
What other research endeavors have been completed involving Pharmacological Study?
"Presently, 18 trials for Pharmacological Study are in operation with 3 of them being at the Phase 3 stage. Although most studies take place in Baltimore, Maryland there are a total of 278 sites hosting clinical examinations related to this medication."
Answered by AI
Is this an experimental trial or has it been tested before?
"Currently, 18 trials studying Pharmacological Study are live in 52 cities and 14 nations. This research was first launched by Celgene Corporation back in 2012 with 37 participants as part of its Phase 1 drug approval cycle. Since then, 214 studies have been successfully completed."
Answered by AI
What is the current patient count for this medical experiment?
"Unfortunately, at this time the recruitment process for this trial has been completed. It was originally posted on June 12th 2012 and last edited in October 19th 2022. For those seeking alternatives, there are 15189 studies regarding lymphoma actively recruiting patients and 18 Pharmacological Studies searching for participants."
Answered by AI
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