Tipifarnib in Treating Patients With Relapsed or Refractory Lymphoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00082888
First received: May 14, 2004
Last updated: May 9, 2014
Last verified: December 2013
Results First Received: November 2, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Anaplastic Large Cell Lymphoma
Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
Nodal Marginal Zone B-cell Lymphoma
Peripheral T-cell Lymphoma
Recurrent Adult Diffuse Large Cell Lymphoma
Recurrent Adult Diffuse Mixed Cell Lymphoma
Recurrent Adult Hodgkin Lymphoma
Recurrent Adult T-cell Leukemia/Lymphoma
Recurrent Grade 1 Follicular Lymphoma
Recurrent Grade 2 Follicular Lymphoma
Recurrent Grade 3 Follicular Lymphoma
Recurrent Mantle Cell Lymphoma
Recurrent Small Lymphocytic Lymphoma
Splenic Marginal Zone Lymphoma
Interventions: Drug: tipifarnib
Other: laboratory biomarker analysis

  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
Participants were recruited from 2 medical clinics in the United States between March 2004 to November 2008.

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
R115777 (Tipifarnib) 300mg twice a day for 21 days. Cycle length is 28 days. After cycle 1, may increase the dose to 400mg twice a day or 600mg twice a day at physician dicretion.

Participant Flow:   Overall Study
    R115777 (Tipifarnib)  
STARTED     93  
COMPLETED     71  
NOT COMPLETED     22  
Death                 2  
Adverse Event                 4  
Withdrawal by Subject                 9  
Alternate Treatment                 1  
Other Medical Problems                 2  
Still receiving treatment                 4  



  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
R115777 (Tipifarnib) 300mg twice a day for 21 days. Cycle length is 28 days. After cycle 1, may increase the dose to 400mg twice a day or 600mg twice a day at physician dicretion.

Baseline Measures
    R115777 (Tipifarnib)  
Number of Participants  
[units: participants]
  93  
Age  
[units: years]
Median ( Full Range )
  62  
  ( 18 to 91 )  
Gender  
[units: participants]
 
Female     42  
Male     51  
Region of Enrollment  
[units: participants]
 
United States     93  
Relapsed or Refractory Lymphoma  
[units: participants]
 
Aggressive     42  
Indolent     15  
Uncommon     36  



  Outcome Measures

1.  Primary:   Proportion of Confirmed Response (Complete Response, Unconfirmed Complete Response, or Partial Response) During the First 6 Courses of Treatment   [ Time Frame: During the first 6 cycles of treatment ]

2.  Secondary:   Overall Survival   [ Time Frame: Up to 2 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Time to Progression   [ Time Frame: up to 2 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Duration of Response   [ Time Frame: up to 2 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Toxicity   [ Time Frame: 3/26/2004 - 2/1/2011 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  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: Thomas E. Witzig, M.D.
Organization: Mayo Clinic
phone: 507-266-2040
e-mail: witzig@mayo.edu


No publications provided by National Cancer Institute (NCI)

Publications automatically indexed to this study:

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00082888     History of Changes
Other Study ID Numbers: NCI-2012-02849, NCI-2012-02849, 6246, LS038B, 6246, P50CA097274
Study First Received: May 14, 2004
Results First Received: November 2, 2011
Last Updated: May 9, 2014
Health Authority: United States: Food and Drug Administration