A Phase II Study of UCN-01 in Metastatic Melanoma

This study has been terminated.
(Early termination for discouraging results)
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00072189
First received: November 4, 2003
Last updated: February 17, 2015
Last verified: October 2013
Results First Received: February 17, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Recurrent Melanoma
Stage IV Melanoma
Interventions: Drug: 7-hydroxystaurosporine
Other: laboratory biomarker analysis
Other: pharmacological study

  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
Arm 1

Patients receive UCN-01 IV at 90 mg/m2 over 3 hours on cycle 1, reduced to 45 mg/m2 over 3 hours for subsequent cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

7-hydroxystaurosporine: Given IV

laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies


Participant Flow:   Overall Study
    Arm 1  
STARTED     17  
COMPLETED     16  
NOT COMPLETED     1  
Withdrawal by Subject                 1  



  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.
No text entered.

Reporting Groups
  Description
Arm 1

Patients receive UCN-01 IV at 90 mg/m2 over 3 hours on cycle 1, reduced to 45 mg/m2 over 3 hours for subsequent cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

7-hydroxystaurosporine: Given IV

laboratory biomarker analysis: Correlative studies

pharmacological study: Correlative studies


Baseline Measures
    Arm 1  
Number of Participants  
[units: participants]
  17  
Age  
[units: years]
Median (Full Range)
  53   (34 to 85)  
Gender  
[units: participants]
 
Female     11  
Male     6  
Region of Enrollment  
[units: participants]
 
United States     17  



  Outcome Measures
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1.  Primary:   Response Rate   [ Time Frame: Up to 7 years ]

2.  Secondary:   Overall Survival   [ Time Frame: Up to 7 years ]

3.  Secondary:   Progression-free Survival   [ Time Frame: From the date of study registration to the first documentation of progressive tumor, assessed up to 7 years ]


  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
Study was terminated early after the first stage of a two-stage design, allowing for early termination for discouraging results


  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: DCC Project Administrator
Organization: California Cancer Consortium
phone: : 626-256-4673 ext 60094
e-mail: CCCP@coh.org


No publications provided by National Cancer Institute (NCI)

Publications automatically indexed to this study:

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00072189     History of Changes
Other Study ID Numbers: NCI-2012-02829, NCI-2012-02829, PHII-33, 5536, N01CM17101
Study First Received: November 4, 2003
Results First Received: February 17, 2015
Last Updated: February 17, 2015
Health Authority: United States: Food and Drug Administration