UCN-01 (7-Hydroxystaurosporine) to Treat Relapsed T-Cell Lymphomas

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wyndham Wilson, National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00082017
First received: April 28, 2004
Last updated: July 26, 2012
Last verified: June 2012
Results First Received: June 6, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Lymphoma, Large-Cell, Ki-1
Lymphoma, T-Cell
Intervention: Drug: UCN-01 (7-hydroxystaurosporine)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
UCN-01 for T-cell Lymphomas - Cohort 1-Every 28 Days

Cohort 1 Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2

Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2. Repeat cycles every 28 days.

UCN-01 for T-cell Lymphomas - Cohort 2 Every 21 Days

Cohort 2 Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2

Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2; Repeat cycles every 21 days.


Participant Flow:   Overall Study
    UCN-01 for T-cell Lymphomas - Cohort 1-Every 28 Days     UCN-01 for T-cell Lymphomas - Cohort 2 Every 21 Days  
STARTED     11     9  
COMPLETED     11     9  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
UCN-01 for T-cell Lymphomas - Cohort 1&2

Cohort 1 Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2

Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2; Repeat cycles every 28 days.

Cohort 2 Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2

Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2; Repeat cycles every 21 days.


Baseline Measures
    UCN-01 for T-cell Lymphomas - Cohort 1&2  
Number of Participants  
[units: participants]
  20  
Age  
[units: participants]
 
<=18 years     5  
Between 18 and 65 years     14  
>=65 years     1  
Age  
[units: years]
Mean ± Standard Deviation
  35.29  ± 18.89  
Gender  
[units: participants]
 
Female     7  
Male     13  
Ethnicity (NIH/OMB)  
[units: Participants]
 
Hispanic or Latino     1  
Not Hispanic or Latino     19  
Unknown or Not Reported     0  
Race (NIH/OMB)  
[units: Participants]
 
American Indian or Alaska Native     1  
Asian     1  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     7  
White     11  
More than one race     0  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
United States     20  



  Outcome Measures
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1.  Primary:   Clinical Response Rate   [ Time Frame: 74.5 months ]

2.  Secondary:   Number of Participants With Adverse Events   [ Time Frame: 76 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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:  
Name/Title: Wyndham Wilson, M.D.
Organization: National Cancer Institute, National Institues of Health
phone: 301-435-2415
e-mail: wilsonw@mail.nih.gov


Publications:

Responsible Party: Wyndham Wilson, National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00082017     History of Changes
Obsolete Identifiers: NCT00085319
Other Study ID Numbers: 040173, 04-C-0173
Study First Received: April 28, 2004
Results First Received: June 6, 2012
Last Updated: July 26, 2012
Health Authority: United States: Federal Government