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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):
Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Non-Hodgkin Lymphoma
Intervention Drug: Intravenous vitamin C
Enrollment 2
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Vitamin C
Hide Arm/Group Description

Intravenous vitamin C

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

Period Title: Overall Study
Started 2
Completed 2
Not Completed 0
Arm/Group Title Vitamin C
Hide Arm/Group Description

Intravenous vitamin C

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

Overall Number of Baseline Participants 2
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2 participants
55.3  (2.9)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
<=18 years
0
   0.0%
Between 18 and 65 years
2
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
Female
1
  50.0%
Male
1
  50.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
1
  50.0%
More than one race
0
   0.0%
Unknown or Not Reported
1
  50.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
Hispanic or Latino
1
  50.0%
Not Hispanic or Latino
1
  50.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants
2
1.Primary Outcome
Title Progression-free Survival
Hide Description [Not Specified]
Time Frame 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vitamin C
Hide Arm/Group Description:

Intravenous vitamin C

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

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Duration of Response
Hide Description [Not Specified]
Time Frame 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vitamin C
Hide Arm/Group Description:

Intravenous vitamin C

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

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Vitamin C
Hide Arm/Group Description

Intravenous vitamin C

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

All-Cause Mortality
Vitamin C
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Vitamin C
Affected / at Risk (%) # Events
Total   0/2 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Vitamin C
Affected / at Risk (%) # Events
Total   2/2 (100.00%)    
General disorders   
Abdominal pain  1/2 (50.00%)  1
Back pain  1/2 (50.00%)  1
Induration at IV site  1/2 (50.00%)  1
Lightheadedness  1/2 (50.00%)  1
Nausea  1/2 (50.00%)  1
Pain at IV site  1/2 (50.00%)  3
Viral illness  1/2 (50.00%)  1
Study was terminated due to poor accrual. No reportable data has been collected for any of the specified outcome measures.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Daniel Monti, MD
Organization: Thomas Jefferson University
Phone: 215-955-4410
EMail: Daniel.Monti@jefferson.edu
Layout table for additonal information
Responsible Party: Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )
ClinicalTrials.gov Identifier: NCT00626444    
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