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

Non-Hodgkin Lymphoma Clinical Trial

Official title:

Phase II Trial of High Dose Intravenous Vitamin C in Patients With Refractory Non-Hodgkin Lymphoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00626444
• Other study ID #: 07U.21
• Status: Terminated
• Phase: Phase 2
• First received: February 21, 2008
• Last updated: December 3, 2014
• Start date: February 2008
• Est. completion date: December 2011

Study information

• Verified date: December 2014
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Non-Hodgkin Lymphoma

Intervention

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

Locations

Country	Name	City	State
United States	Jefferson-Myrna Brind Center of Integrative Medicine	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free Survival		10 weeks	No
Secondary	Duration of Response		10 weeks	No