Trial of Low-Dose Methotrexate and I 131 Tositumomab for Previously Untreated, Advanced-Stage, Follicular Lymphoma

This study has been terminated.
(Bexxar isn't being produced by the manufacturer as of Feb. 2014)
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
University of Michigan Cancer Center
ClinicalTrials.gov Identifier:
NCT01389076
First received: July 5, 2011
Last updated: June 2, 2016
Last verified: June 2016
Results First Received: June 2, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Follicular Lymphoma
Intervention: Drug: Low dose methotrexate and Bexxar

  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
Methotrexate and Bexxar

Low dose methotrexate and Bexxar (tositumomab)

Patients will begin taking methotrexate 7.5 mg orally once weekly 3 weeks prior to initiating I-131 tositumomab, with additional weekly doses once I-131 tositumomab therapy has begun for a total of 10 doses.

On Study Day 0, patients will receive the IV administration of 450 mg unlabeled tositumomab followed by the IV administration of the dosimetric dose (5 mCi of Iodine I 131 tositumomab).


Participant Flow:   Overall Study
    Methotrexate and Bexxar  
STARTED     22  
COMPLETED     22  
NOT COMPLETED     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
Methotrexate and Bexxar

Low dose methotrexate and Bexxar (tositumomab)

Patients will begin taking methotrexate 7.5 mg orally once weekly 3 weeks prior to initiating I-131 tositumomab, with additional weekly doses once I-131 tositumomab therapy has begun for a total of 10 doses.

On Study Day 0, patients will receive the IV administration of 450 mg unlabeled tositumomab followed by the IV administration of the dosimetric dose (5 mCi of Iodine I 131 tositumomab).


Baseline Measures
    Methotrexate and Bexxar  
Number of Participants  
[units: participants]
  22  
Age  
[units: years]
Median (Full Range)
  56  
  (36 to 74)  
Gender  
[units: participants]
 
Female     9  
Male     13  



  Outcome Measures
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1.  Primary:   Rate of Early Onset HAMA (Human Anti-mouse Antibody) Conversion Following Treatment   [ Time Frame: 2 years ]

2.  Secondary:   Percentage of Participants That Respond to Treatment   [ Time Frame: 2 years ]

3.  Secondary:   The Percentage of Participants Alive at 2 Years   [ Time Frame: 2 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
This trial was abandoned prematurely due to the withdrawal of Bexxar by the manufacturer and failure to find another supplier.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Mark Kaminski, M.D.
Organization: University of Michigan Comprehensive Cancer Center
phone: 734-936-5310
e-mail: mkaminsk@umich.edu



Responsible Party: University of Michigan Cancer Center
ClinicalTrials.gov Identifier: NCT01389076     History of Changes
Other Study ID Numbers: UMCC 2010.098
HUM00043235 ( Other Identifier: University of Michigan IRBMED )
Study First Received: July 5, 2011
Results First Received: June 2, 2016
Last Updated: June 2, 2016
Health Authority: United States: Institutional Review Board