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Fenretinide and Rituximab in Treating Patients With B-Cell Non-Hodgkin Lymphoma

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ClinicalTrials.gov Identifier: NCT00288067
Recruitment Status : Terminated (NCI stopped supplying fenretinide in November of 2012.)
First Posted : February 7, 2006
Results First Posted : October 6, 2014
Last Update Posted : October 6, 2014
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Adult Nodular Lymphocyte Predominant Hodgkin Lymphoma
B-cell Chronic Lymphocytic Leukemia
Contiguous Stage II Adult Burkitt Lymphoma
Contiguous Stage II Adult Diffuse Large Cell Lymphoma
Contiguous Stage II Adult Lymphoblastic Lymphoma
Contiguous Stage II Grade 1 Follicular Lymphoma
Contiguous Stage II Grade 2 Follicular Lymphoma
Contiguous Stage II Mantle Cell Lymphoma
Stage II Marginal Zone Lymphoma
Stage II Small Lymphocytic Lymphoma
Extranodal Marginal Zone B-cell Lymphoma
Nodal Marginal Zone B-cell Lymphoma
Noncontiguous Stage II Adult Burkitt Lymphoma
Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma
Noncontiguous Stage II Adult Lymphoblastic Lymphoma
Noncontiguous Stage II Grade 1 Follicular Lymphoma
Noncontiguous Stage II Grade 2 Follicular Lymphoma
Noncontiguous Stage II Mantle Cell Lymphoma
Recurrent Adult Burkitt Lymphoma
Recurrent Adult Diffuse Large Cell Lymphoma
Recurrent Adult Hodgkin Lymphoma
Recurrent Adult Lymphoblastic Lymphoma
Recurrent Grade 1 Follicular Lymphoma
Recurrent Grade 2 Follicular Lymphoma
Recurrent Mantle Cell Lymphoma
Recurrent Marginal Zone Lymphoma
Recurrent Small Lymphocytic Lymphoma
Refractory Chronic Lymphocytic Leukemia
Splenic Marginal Zone Lymphoma
Stage I Adult Burkitt Lymphoma
Stage I Adult Diffuse Large Cell Lymphoma
Stage I Adult Hodgkin Lymphoma
Stage I Adult Lymphoblastic Lymphoma
Stage I Chronic Lymphocytic Leukemia
Stage I Grade 1 Follicular Lymphoma
Stage I Grade 2 Follicular Lymphoma
Stage I Small Lymphocytic Lymphoma
Stage II Adult Hodgkin Lymphoma
Stage II Chronic Lymphocytic Leukemia
Stage III Adult Burkitt Lymphoma
Stage III Adult Diffuse Large Cell Lymphoma
Stage III Adult Hodgkin Lymphoma
Stage III Adult Lymphoblastic Lymphoma
Stage III Chronic Lymphocytic Leukemia
Stage III Grade 1 Follicular Lymphoma
Stage III Grade 2 Follicular Lymphoma
Stage III Mantle Cell Lymphoma
Stage III Marginal Zone Lymphoma
Stage III Small Lymphocytic Lymphoma
Stage IV Adult Burkitt Lymphoma
Stage IV Adult Diffuse Large Cell Lymphoma
Stage IV Adult Hodgkin Lymphoma
Stage IV Adult Lymphoblastic Lymphoma
Stage IV Chronic Lymphocytic Leukemia
Stage IV Grade 1 Follicular Lymphoma
Stage IV Grade 2 Follicular Lymphoma
Stage IV Mantle Cell Lymphoma
Stage IV Marginal Zone Lymphoma
Stage IV Small Lymphocytic Lymphoma
Waldenström Macroglobulinemia
Interventions: Drug: fenretinide
Drug: rituximab

  Participant Flow

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
Fenretinide and Rituximab

PHASE I: Patients receive fenretinide PO BID on days 1-5. Treatment repeats weekly for at least 4 weeks in the absence of disease progression or unacceptable toxicity.

PHASE II: Patients receive fenretinide PO BID on days 1-5 in weeks 1-8 and rituximab IV once weekly in weeks 5-8. Treatment continues in the absence of disease progression or unacceptable toxicity.

pharmacological study : Correlative studies

rituximab : Given IV

fenretinide : Given PO


Participant Flow:   Overall Study
    Fenretinide and Rituximab
STARTED   32 
COMPLETED   32 
NOT COMPLETED   0 



  Baseline Characteristics

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
Fenretinide and Rituximab

PHASE I: Patients receive fenretinide PO BID on days 1-5. Treatment repeats weekly for at least 4 weeks in the absence of disease progression or unacceptable toxicity.

PHASE II: Patients receive fenretinide PO BID on days 1-5 in weeks 1-8 and rituximab IV once weekly in weeks 5-8. Treatment continues in the absence of disease progression or unacceptable toxicity.

pharmacological study : Correlative studies

rituximab : Given IV

fenretinide : Given PO


Baseline Measures
   Fenretinide and Rituximab 
Overall Participants Analyzed 
[Units: Participants]
 32 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   19 
>=65 years   13 
Age 
[Units: Years]
Mean (Standard Deviation)
 62  (10) 
Gender 
[Units: Participants]
 
Female   6 
Male   26 
Region of Enrollment 
[Units: Participants]
 
United States   32 


  Outcome Measures

1.  Primary:   Safety, in Terms of Dose-limiting Toxicity (DLT) of 2 Daily Doses of Single Agent Fenretinide (Phase I)   [ Time Frame: Number of participants that experienced a dose-limiting toxicity ]

2.  Primary:   Response Rates of B-Non-Hodgkin Lymphoma to the Combination of Rituximab and Fenretinide (Phase II)   [ Time Frame: Up to 7 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

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: Dr. Ajay Gopal
Organization: University of Washington
phone: 206-288-2035
e-mail: agopal@uw.edu



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00288067     History of Changes
Other Study ID Numbers: NCI-2009-00104
NCI-2009-00104 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000456502 ( Other Identifier: NCI )
UWCC-UW-6071 ( Other Identifier: Fred Hutchinson Cancer Research Center )
UWCC-06-0644-H/A ( Other Identifier: Fred Hutchinson Cancer Research Center )
UWCC-6071 ( Other Identifier: Fred Hutchinson Cancer Research Center )
FHCRC-6071 ( Other Identifier: Fred Hutchinson Cancer Research Center )
6071 ( Other Identifier: University of Washington Medical Center )
6957 ( Other Identifier: CTEP )
R21CA119519 ( U.S. NIH Grant/Contract )
First Submitted: February 6, 2006
First Posted: February 7, 2006
Results First Submitted: January 8, 2014
Results First Posted: October 6, 2014
Last Update Posted: October 6, 2014