Pilot Trial of Intravenous Vitamin C in Refractory Non-Hodgkin Lymphoma (NHL)

This study has been terminated.
(Slow accrual)
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT00626444
First received: February 21, 2008
Last updated: December 3, 2014
Last verified: December 2014
Results First Received: November 24, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Non-Hodgkin Lymphoma
Intervention: Drug: Intravenous vitamin C

  Participant Flow
  Hide 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
Vitamin C

Intravenous vitamin C

Intravenous vitamin C: Up to 100 gms of intravenous vitamin C, three times per week for 10 weeks.


Participant Flow:   Overall Study
    Vitamin C  
STARTED     2  
COMPLETED     2  
NOT COMPLETED     0  



  Baseline Characteristics
  Hide 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
Vitamin C

Intravenous vitamin C

Intravenous vitamin C: Up to 100 gms of intravenous vitamin C, three times per week for 10 weeks.


Baseline Measures
    Vitamin C  
Number of Participants  
[units: participants]
  2  
Age  
[units: years]
Mean ± Standard Deviation
  55.3  ± 2.9  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     2  
>=65 years     0  
Gender  
[units: participants]
 
Female     1  
Male     1  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     0  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     0  
White     1  
More than one race     0  
Unknown or Not Reported     1  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     1  
Not Hispanic or Latino     1  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
United States     2  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Progression-free Survival   [ Time Frame: 10 weeks ]

2.  Secondary:   Duration of Response   [ Time Frame: 10 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
Study was terminated due to poor accrual. No reportable data has been collected for any of the specified outcome measures.


  More Information
  Hide More Information

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


Results Point of Contact:  
Name/Title: Daniel Monti, MD
Organization: Thomas Jefferson University
phone: 215-955-4410
e-mail: Daniel.Monti@jefferson.edu


No publications provided


Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT00626444     History of Changes
Other Study ID Numbers: 07U.21
Study First Received: February 21, 2008
Results First Received: November 24, 2014
Last Updated: December 3, 2014
Health Authority: United States: Food and Drug Administration