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

This study has been terminated.
(IND was withdrawn by CTEP due to low accrual and cost of maintaining the IND.)
Sponsor:
Information provided by (Responsible Party):
Wyndham Wilson, M.D., National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00082017
First received: April 28, 2004
Last updated: May 1, 2017
Last verified: May 2017
Results First Received: June 6, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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 
Overall Participants Analyzed 
[Units: Participants]
 20 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      5  25.0% 
Between 18 and 65 years      14  70.0% 
>=65 years      1   5.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 35.29  (18.89) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      7  35.0% 
Male      13  65.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      1   5.0% 
Not Hispanic or Latino      19  95.0% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      1   5.0% 
Asian      1   5.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      7  35.0% 
White      11  55.0% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   20 


  Outcome Measures
  Show All Outcome Measures

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

2.  Primary:   Progression Free Survival (PFS)   [ Time Frame: 3.6 months ]

3.  Primary:   Overall Survival (OS)   [ Time Frame: 55 months ]

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

5.  Other Pre-specified:   Effect of UCN-01 on Soluble TAC Cluster of Differentiation 25 (CD25)   [ Time Frame: Day 3-5 after drug administration ]

6.  Other Pre-specified:   Evaluation of Mature T-cell Lymphoma Cells by Complementary Double-Stranded Deoxyribonucleic Acid (cDNA) Microarray   [ Time Frame: Day 3-5 after drug administration ]

7.  Other Pre-specified:   Effect of UCN-01 on Anaplastic Lymphoma Kinase (ALK) Expression in ALCL   [ Time Frame: Day 3-5 after drug administration ]


  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, M.D., 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: May 1, 2017