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Lenalidomide in Treating Patients With AIDS-Associated Kaposi's Sarcoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01057121
First received: January 26, 2010
Last updated: June 7, 2016
Last verified: June 2016
Results First Received: March 4, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: AIDS-Related Kaposi Sarcoma
Recurrent Kaposi Sarcoma
Intervention: Drug: Lenalidomide

  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
Phase I: Treatment (Lenalidomide) , 10 mg/Day Patients receive 10 mg lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Phase I: Treatment (Lenalidomide), 15 mg/Day Patients receive 15 mg lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Phase I, Treatment Ienalidomide), 20 mg/Day Patients receive 20 mg lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Phase I: Treatment (Lenalidomide), 25 mg/Day Patients receive 25 mg lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Phase II: Treatment (Lenalidomide), 25 mg/Day Patients receive 25 mg lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Participant Flow for 5 periods

Period 1:   Phase I: 10 mg/Day Lenalidomide
    Phase I: Treatment (Lenalidomide) , 10 mg/Day   Phase I: Treatment (Lenalidomide), 15 mg/Day   Phase I, Treatment Ienalidomide), 20 mg/Day   Phase I: Treatment (Lenalidomide), 25 mg/Day   Phase II: Treatment (Lenalidomide), 25 mg/Day
STARTED   3   0   0   0   0 
COMPLETED   3   0   0   0   0 
NOT COMPLETED   0   0   0   0   0 

Period 2:   Phase I: 15 mg/Day Lenolidomide
    Phase I: Treatment (Lenalidomide) , 10 mg/Day   Phase I: Treatment (Lenalidomide), 15 mg/Day   Phase I, Treatment Ienalidomide), 20 mg/Day   Phase I: Treatment (Lenalidomide), 25 mg/Day   Phase II: Treatment (Lenalidomide), 25 mg/Day
STARTED   0   3   0   0   0 
COMPLETED   0   3   0   0   0 
NOT COMPLETED   0   0   0   0   0 

Period 3:   Phase I: 20 mg/Day Lenalidomide
    Phase I: Treatment (Lenalidomide) , 10 mg/Day   Phase I: Treatment (Lenalidomide), 15 mg/Day   Phase I, Treatment Ienalidomide), 20 mg/Day   Phase I: Treatment (Lenalidomide), 25 mg/Day   Phase II: Treatment (Lenalidomide), 25 mg/Day
STARTED   0   0   3   0   0 
COMPLETED   0   0   3   0   0 
NOT COMPLETED   0   0   0   0   0 

Period 4:   Phase I: 25 mg/Day Lenalidomide
    Phase I: Treatment (Lenalidomide) , 10 mg/Day   Phase I: Treatment (Lenalidomide), 15 mg/Day   Phase I, Treatment Ienalidomide), 20 mg/Day   Phase I: Treatment (Lenalidomide), 25 mg/Day   Phase II: Treatment (Lenalidomide), 25 mg/Day
STARTED   0   0   0   6   0 
COMPLETED   0   0   0   6   0 
NOT COMPLETED   0   0   0   0   0 

Period 5:   Phase II: 25 mg/Day Lenalidomide
    Phase I: Treatment (Lenalidomide) , 10 mg/Day   Phase I: Treatment (Lenalidomide), 15 mg/Day   Phase I, Treatment Ienalidomide), 20 mg/Day   Phase I: Treatment (Lenalidomide), 25 mg/Day   Phase II: Treatment (Lenalidomide), 25 mg/Day
STARTED   0   0   0   0   23 
COMPLETED   0   0   0   0   23 
NOT COMPLETED   0   0   0   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.
No text entered.

Reporting Groups
  Description
Phase I - Treatment (Lenalidomide)

Patients receive lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles

Phase II - Treatment (Lenalidomide)

Patients receive lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles

Total Total of all reporting groups

Baseline Measures
   Phase I - Treatment (Lenalidomide)   Phase II - Treatment (Lenalidomide)   Total 
Overall Participants Analyzed 
[Units: Participants]
 15   23   38 
Age 
[Units: Years]
Mean (Standard Deviation)
 47.2  (11.8)   46.9  (8.2)   47.0  (9.6) 
Gender 
[Units: Participants]
     
Female   0   0   0 
Male   15   23   38 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   4   4   8 
Not Hispanic or Latino   11   18   29 
Unknown or Not Reported   0   1   1 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   0   0   0 
Asian   1   0   1 
Native Hawaiian or Other Pacific Islander   1   1   2 
Black or African American   1   5   6 
White   12   14   26 
More than one race   0   2   2 
Unknown or Not Reported   0   1   1 
Region of Enrollment 
[Units: Participants]
     
United States   15   23   38 


  Outcome Measures
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1.  Primary:   Maximum Tolerated Dose of Lenalidomide Defined as the Dose Level at Which 0/6 or 1/6 Subjects Experience Dose Limiting Toxicity (DLT) With the Next Higher Dose Having at Least 2/3 or 2/6 Subjects Encountering DLT (Phase I)   [ Time Frame: 28 days ]

2.  Primary:   Tumor Response Rate   [ Time Frame: Up to 30 days after completion of study treatment ]

3.  Secondary:   Time to Death   [ Time Frame: Up to 30 days after completion of study treatment ]

4.  Secondary:   Time to Relapse   [ Time Frame: Up to 30 days after completion of study treatment ]

5.  Secondary:   Time to Response   [ Time Frame: Up to 30 days after completion of study treatment ]

6.  Other Pre-specified:   Relationship Between Clinical Response and Quantitative Measures of Kaposi's Sarcoma-associated Herpesvirus (KSHV)/HHV-8 and HIV Viral Load   [ Time Frame: Up to 30 days after completion of study treatment ]


  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 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: AMC Statistical Center
Organization: AIDS Malignancy Consortium
phone: 501-526-6712
e-mail: jylee@uams.edu



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01057121     History of Changes
Other Study ID Numbers: NCI-2012-02923
NCI-2012-02923 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000664131
AMC-070 ( Other Identifier: AIDS - Associated Malignancies Clinical Trials Consortium )
AMC-070 ( Other Identifier: CTEP )
U01CA121947 ( US NIH Grant/Contract Award Number )
Study First Received: January 26, 2010
Results First Received: March 4, 2016
Last Updated: June 7, 2016
Health Authority: United States: Food and Drug Administration