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Trial record 68 of 881 for:    "Reticulum Cell Sarcoma"

FR901228 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

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ClinicalTrials.gov Identifier: NCT00383565
Recruitment Status : Terminated
First Posted : October 3, 2006
Results First Posted : August 22, 2012
Last Update Posted : May 20, 2014
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Recurrent Adult Diffuse Large Cell Lymphoma
Recurrent Mantle Cell Lymphoma
Intervention Drug: romidepsin
Enrollment 9
Recruitment Details Recruitment Period: September 20, 2006 to May 08, 2009. All recruitment done at UT MD Anderson Cancer Center.
Pre-assignment Details  
Arm/Group Title FR901228
Hide Arm/Group Description 13 mg/m^2 FR901228 by vein (IV) over 4 hours on days 1, 8, and 15
Period Title: Overall Study
Started 9
Completed 9
Not Completed 0
Arm/Group Title FR901228
Hide Arm/Group Description 13 mg/m^2 FR901228 by vein (IV) over 4 hours on days 1, 8, and 15
Overall Number of Baseline Participants 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
<=18 years
0
   0.0%
Between 18 and 65 years
4
  44.4%
>=65 years
5
  55.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants
66.8  (12.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
Female
1
  11.1%
Male
8
  88.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 9 participants
9
1.Primary Outcome
Title Overall Objective Response Rate (Complete Response [CR] and Partial Response [PR]) After 6 Courses of Treatment
Hide Description International Working Group response for non- Hodgkin's lymphoma: Complete Response (CR) - disappearance all detectable clinical/radiographic evidence of disease and disappearance of all disease-related symptoms (present before therapy) and normalization of those biochemical abnormalities; Partial Response (PR) - ≥50% decrease in sum products of greatest diameters (SPD) of 6 largest dominant nodes or nodal masses, selected by clearly measurable in at least two perpendicular dimensions, from disparate regions of body and no decrease in size of other nodes, liver, or spleen.
Time Frame 24 weeks (6 courses of 4 week cycles)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FR901228
Hide Arm/Group Description:
13 mg/m^2 FR901228 by vein (IV) over 4 hours on days 1, 8, and 15
Overall Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: participants
Complete Response 0
Partial Response 1
2.Secondary Outcome
Title Median Progression Free-survival (PFS)
Hide Description Time to disease progression is defined as the time from registration to documentation of disease progression.
Time Frame 2 Years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FR901228
Hide Arm/Group Description:
13 mg/m^2 FR901228 by vein (IV) over 4 hours on days 1, 8, and 15
Overall Number of Participants Analyzed 9
Median (Full Range)
Unit of Measure: months
4
(1 to 7)
3.Secondary Outcome
Title Median Overall Survival
Hide Description Survival time is defined as the time from registration to death due to any cause, measured in months. The distribution of survival time estimated using the method of Kaplan-Meier.
Time Frame 5 Years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FR901228
Hide Arm/Group Description:
13 mg/m^2 FR901228 by vein (IV) over 4 hours on days 1, 8, and 15
Overall Number of Participants Analyzed 9
Median (Full Range)
Unit of Measure: months
20
(1 to 53)
Time Frame 3 years and 9 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title FR901228
Hide Arm/Group Description 13 mg/m^2 FR901228 by vein (IV) over 4 hours on days 1, 8, and 15
All-Cause Mortality
FR901228
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
FR901228
Affected / at Risk (%)
Total   6/9 (66.67%) 
Cardiac disorders   
Cardiac Arrhythmia  1  1/9 (11.11%) 
Infectious Endocarditis  1  1/9 (11.11%) 
Eye disorders   
Diplopia  1  1/9 (11.11%) 
Gastrointestinal disorders   
Dysphagia  1  1/9 (11.11%) 
General disorders   
Death NOS  1 [1]  1/9 (11.11%) 
Non-neutropenic fever  1  1/9 (11.11%) 
Fatigue  1  1/9 (11.11%) 
Infections and infestations   
Neutropenia  1  1/9 (11.11%) 
Thrombocytopenia  1  2/9 (22.22%) 
Infection  1  1/9 (11.11%) 
Metabolism and nutrition disorders   
Glucose, serum-high  1  1/9 (11.11%) 
Increased Alkaline phosphatase  1  1/9 (11.11%) 
Vascular disorders   
DVT, Vascular access-related  1 [2]  1/9 (11.11%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
NOS = Not Otherwise Specified
[2]
Deep vein thrombosis = DVT
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
FR901228
Affected / at Risk (%)
Total   9/9 (100.00%) 
Blood and lymphatic system disorders   
anemia  1  7/9 (77.78%) 
Cardiac disorders   
sinus tachycardia  1  1/9 (11.11%) 
Eye disorders   
blurry vision  1  2/9 (22.22%) 
Gastrointestinal disorders   
nausea  1  6/9 (66.67%) 
constipation  1  3/9 (33.33%) 
diarrhea  1  3/9 (33.33%) 
gastritis  1  1/9 (11.11%) 
hemorrhoids  1  1/9 (11.11%) 
mucositis oral  1  1/9 (11.11%) 
oral pain  1  1/9 (11.11%) 
periodontal disease  1  1/9 (11.11%) 
rectal pain  1  1/9 (11.11%) 
stomach pain  1  1/9 (11.11%) 
vomiting  1  3/9 (33.33%) 
taste alteration  1  1/9 (11.11%) 
General disorders   
fatigue  1  5/9 (55.56%) 
fever  1  2/9 (22.22%) 
edema limbs  1  2/9 (22.22%) 
Infections and infestations   
infection with normal Absolute neutrophil count (ANC)  1  7/9 (77.78%) 
sinusitis  1  1/9 (11.11%) 
Investigations   
weight loss  1  2/9 (22.22%) 
thrombocytopenia  1  8/9 (88.89%) 
alanine aminotransferase (ALT)  1  2/9 (22.22%) 
aspartate aminotransferase (AST)  1  3/9 (33.33%) 
alkaline phosphatase  1  3/9 (33.33%) 
creatinine  1  1/9 (11.11%) 
lymphopenia  1  6/9 (66.67%) 
leukopenia  1  3/9 (33.33%) 
neutropenia  1  2/9 (22.22%) 
Metabolism and nutrition disorders   
hyperglycemia  1  4/9 (44.44%) 
anorexia  1  2/9 (22.22%) 
hypocalcemia  1  2/9 (22.22%) 
hypoalbuminemia  1  4/9 (44.44%) 
hyperuricemia  1  1/9 (11.11%) 
hypoglycemia  1  1/9 (11.11%) 
hyperkalemia  1  4/9 (44.44%) 
hypomagnesemia  1  2/9 (22.22%) 
hyponatremia  1  2/9 (22.22%) 
hypophosphatemia  1  3/9 (33.33%) 
Musculoskeletal and connective tissue disorders   
myalgia  1  3/9 (33.33%) 
Nervous system disorders   
sensory neuropathy  1  2/9 (22.22%) 
dizziness  1  2/9 (22.22%) 
headache  1  1/9 (11.11%) 
Respiratory, thoracic and mediastinal disorders   
dyspnea  1  1/9 (11.11%) 
pneumonitis  1  1/9 (11.11%) 
cough  1  1/9 (11.11%) 
Skin and subcutaneous tissue disorders   
pruritus  1  1/9 (11.11%) 
Vascular disorders   
hypotension  1  1/9 (11.11%) 
thrombosis  1  1/9 (11.11%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Luis E. Fayad / Associate Professor
Organization: MD Anderson Cancer Center
Phone: 713-792-2860
EMail: jmdennison@mdanderson.org
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00383565     History of Changes
Other Study ID Numbers: NCI-2009-00240
NCI-2009-00240 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2005-0579
CDR0000486326
2005-0579 ( Other Identifier: M D Anderson Cancer Center )
7869 ( Other Identifier: CTEP )
P30CA016672 ( U.S. NIH Grant/Contract )
N01CM62202 ( U.S. NIH Grant/Contract )
First Submitted: September 29, 2006
First Posted: October 3, 2006
Results First Submitted: July 19, 2012
Results First Posted: August 22, 2012
Last Update Posted: May 20, 2014