A Multicenter, Open-Label Continuation Trial Evaluating the Tolerability and Activity of Depsipeptide (FK228) in Patients That Have Completed a Prior Clinical Study With Depsipeptide.

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2005 by Royal Marsden NHS Foundation Trust.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00299351
First received: March 3, 2006
Last updated: NA
Last verified: November 2005
History: No changes posted
  Purpose

To evaluate the safety and tolerability of extended treatment with depsipeptide in patients who have at least demonstrated stable disease on prior Gloucester-sponsored depsipeptide clinical trials, and in the opinion of their physician/ investigator might benefit from continued treatment with depsipeptide


Condition Intervention Phase
Peripheral T Cell Lymphoma (PTCL)
Drug: Depsipeptide
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Royal Marsden NHS Foundation Trust:

Estimated Enrollment: 8
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Written informed consent/ authorization Patient has completed 6 cycles of therapy in a prior Gloucester-sponsored depsipeptide clinical trial Patient has immediate past participation (not to exceed 21 days from Day 15 of cycle 6 in the previous study) in a prior Gloucester-sponsored depsipeptide clinical trial Patient has demonstrated stable disease, partial response or complete response as best overall response in their prior Gloucester-sponsored depsipeptide clinical trial and such response must be ongoing at the time of enrollment Patient must have serum potassium levels >4.0mEq/L and serum magnesium levels >2.0mg/dL Negative urine or serum pregnancy test on females of childbearing potential Sexually active females of child-bearing potential must be willing to practice reliable methods of birth control to prevent pregnancy after entering the trial Sexually active males must be willing to practice reliable methods of birht control after entering the trial

Exclusion Criteria:

Patients wiht known cardiac abnormalities such as

  • congenital long QT syndrome
  • QTc interval >480 milliseconds Patients with any cardiac arrhythmia requiring anti-arrhythmic medication Patients who have had a history of coronary artery disease (CAD) eg. angina Canadian class II-IV (see appendix G)> In any patient whom there is doubt, the patient should have a stress imaging study and, if abnormal, angiopathy to define whether or not CAD is present Patients who have had a myocardial infarction within 12 months of study entry. Patients with an ECG recorded at screening showing evidence of cardiac ishemia (ST depression of >2mm). If in any doubt, the patient should have a stress imaging study and if abnormal, angiograpphy to define whether or not CAD is present Patients with congestive heart failure that meets New York heart Association (NYHA) Class II to IV (see appendix F) definitions and/or ejection fraction <40% by MUGA scan or <50% by echocardiogram and/or magnetic resonance imaging (MRI) Patients with a history of sustained VT,VF,Torsade de Pointes, or cardiac arrest unless currently addressed with an automatic implantable cardioverter defibrillator (AICD) Patients with a hypertrophic cardiomelagy or restrictive cardiomyopathy from prior treatment or other causes (in doubt, see ejection fraction criteria above) Patients with uncontrolled hypertension ie > 160/95 Concomitant use of medications which may cause a prolongation of QT/QTc Concomitant use of medications that are inhibitors of the cytochrome P-450 isoenzyme CYP 3A4 Absolute neutrophil count (ANC) < 1.5 X 109 cells/L Platelet count <75 x 109 cells/L Serum creatinine concentration >2 mg/dL or creatinine clearance <40mL/min AST (aspartate aminotransferase ) and alanine aminotransferase (ALT) >2.0 x ULN or >5 X ULN in presence of demonstable liver metastasis Bilirubin concentration > 1.25 x ULN or > 2.0 x ULN in presence of demonstrable liver metastases Serum potassium <4.0mEq/L and serum magnesium <2.0 mg/dL Failure to recover of any drug-related non-hematological toxicity to grade 1 oe less or to baseline values unless otherwise indicated Concomitant use of warfarin (due to a potentialdrug to drug interaction with depsipeptide) Patient is pregnant or nursing Patient had been on prior Gloucester-sponsored depsipeptide clinical trial, left the trial and then received alternative neoplastic therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00299351

Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
Investigators
Principal Investigator: Dr Johann De Bono Royal Marsden NHS Foundation Trust
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00299351     History of Changes
Other Study ID Numbers: CCR2742
Study First Received: March 3, 2006
Last Updated: March 3, 2006
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Romidepsin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014