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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT00626444
First received: February 21, 2008
Last updated: November 18, 2014
Last verified: November 2014

February 21, 2008
November 18, 2014
February 2008
December 2011   (final data collection date for primary outcome measure)
Progression-free survival [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00626444 on ClinicalTrials.gov Archive Site
Duration of response [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Pilot Trial of Intravenous Vitamin C in Refractory Non-Hodgkin Lymphoma (NHL)
Phase II Trial of High Dose Intravenous Vitamin C in Patients With Refractory Non-Hodgkin Lymphoma

Eligible candidates will be adults with aggressive or very aggressive NHL (WHO classification diagnosis confirmed by histological tumor examination). Patients must have failed one or more prior NHL chemotherapy or antibody therapy with curative intent, and the disease must not have progressed within 60 days of last therapy. In addition, patients must not be candidates for potentially curative therapy, such as HSCT, or they must have refused these alternative therapies. Full inclusion/exclusion criteria are available. History and physical examination, and laboratory and imaging analyses will be done within 14 days prior to registration. Intravenous ascorbic acid will be given in a dose based on the plasma vitamin C level to reach a level in the range of 300 to 350 mg/dL. Vitamin C infusions will be given three times a week on a schedule that allows at least 24 hours between each infusion, for a total of ten weeks (30 infusions). If disease progression occurs before or at the ten week assessment, then we discontinue protocol, based on futility. Toxicity and adverse events also will result in immediate discontinuation (details available in full protocol). If there is lack of disease progression or disease improvement, proceed and reassess again at 10 week intervals, for a total of three 10 week intervals. Initial criteria are based upon the criteria from the International Workshop to Standardize Criteria for Non-Hodgkin's Lymphoma (Cheson et al., Report of an international workshop to standardize response criteria for non-Hodgkin's lymphoma, Journal of Clinical Oncology, 1999, Vol. 17, No4, 1244-1253); response for this study will utilize PET in accordance with revised criteria (Cheson et al. Revised response criteria for malignant lymphoma. J of Clin Oncol 2007; 25(5): 579-586). We select 20 patients as an appropriate study size to evaluate a true response rate to therapy, compared to just the observed response.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-Hodgkin Lymphoma
Drug: Intravenous vitamin C
Up to 100 gms of intravenous vitamin C, three times per week for 10 weeks.
Experimental: 1
Intravenous vitamin C
Intervention: Drug: Intravenous vitamin C
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
December 2011
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age greater than 18 years old
  • Aggressive or very aggressive NHL
  • Failed one or more therapies
  • Patients must not have progressed within 60 days of last therapy
  • Not received allogeneic stem cell transplant
  • No reasonable standard therapeutic options available
  • Glucose 6 phosphate dehydrogenase status normal
  • ECOG performance status 0-2
  • Normal creatinine and transaminase
  • Women of child-bearing potential confirm negative pregnancy test

Exclusion Criteria:

  • Significant co-morbid disorders
  • Significant psychiatric symptoms
  • Smoking
  • Excessive alcohol or drug use
  • Enrollment in other experimental therapy
  • Active infection
  • Patients experiencing ongoing response to recent treatments
  • Patients who have received chemotherapy within 30 days or biological therapy within 6 weeks
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00626444
07U.21
Yes
Thomas Jefferson University
Thomas Jefferson University
Not Provided
Principal Investigator: Daniel Monti, MD Faculty Member
Thomas Jefferson University
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP