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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00626444
Recruitment Status : Terminated (Slow accrual)
First Posted : February 29, 2008
Results First Posted : December 10, 2014
Last Update Posted : November 29, 2016
Sponsor:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Non-Hodgkin Lymphoma
Intervention: Drug: Intravenous vitamin C

  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

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 
Overall Participants Analyzed 
[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

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

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

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



Responsible Party: Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )
ClinicalTrials.gov Identifier: NCT00626444     History of Changes
Other Study ID Numbers: 07U.21
First Submitted: February 21, 2008
First Posted: February 29, 2008
Results First Submitted: November 24, 2014
Results First Posted: December 10, 2014
Last Update Posted: November 29, 2016