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

• ClinicalTrials.gov Identifier: NCT00626444
• Recruitment Status: Terminated
• First Posted: February 29, 2008
• Results First Posted: December 10, 2014
• Last Update Posted: November 29, 2016
• Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University
• Information provided by (Responsible Party): Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )

Tracking Information

• First Submitted Date: February 21, 2008
• First Posted Date: February 29, 2008
• Results First Submitted Date: November 24, 2014
• Results First Posted Date: December 10, 2014
• Last Update Posted Date: November 29, 2016
• Study Start Date: February 2008
• Actual Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: December 3, 2014): Progression-free Survival [ Time Frame: 10 weeks ]
• Original Primary Outcome Measures (submitted: February 28, 2008): Progression-free survival [ Time Frame: 10 weeks ]
• Current Secondary Outcome Measures (submitted: December 3, 2014): Duration of Response [ Time Frame: 10 weeks ]
• Original Secondary Outcome Measures (submitted: February 28, 2008): Duration of response [ Time Frame: 10 weeks ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Pilot Trial of Intravenous Vitamin C in Refractory Non-Hodgkin Lymphoma (NHL)
• Official Title: Phase II Trial of High Dose Intravenous Vitamin C in Patients With Refractory Non-Hodgkin Lymphoma
• Brief Summary: 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• 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

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

Study Arms

Experimental: 1

Intravenous vitamin C

Intervention: Drug: Intravenous vitamin C

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: December 3, 2014): 2
• Original Estimated Enrollment (submitted: February 28, 2008): 20
• Actual Study Completion Date: December 2011
• Actual Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00626444
• Other Study ID Numbers: 07U.21
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )
• Original Responsible Party: Daniel A. Monti, MD, Thomas Jefferson University
• Current Study Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University
• Original Study Sponsor: Thomas Jefferson University
• Collaborators: Not Provided

Investigators

• Principal Investigator: Daniel Monti, MD; Faculty Member

• PRS Account: Thomas Jefferson University
• Verification Date: October 2016