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

• Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00626444
• Collaborator: (none)
• Enrollment: 2
• Location: 1
• Arm: 1
• Duration (Months): 46
• Patients Per Site Per Month: 0

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non-Hodgkin Lymphoma	Drug: Intravenous vitamin C	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 2 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase II Trial of High Dose Intravenous Vitamin C in Patients With Refractory Non-Hodgkin Lymphoma
• Study Start Date: Feb 1, 2008
• Actual Primary Completion Date: Dec 1, 2011
• Actual Study Completion Date: Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Intravenous vitamin C	Drug: Intravenous vitamin C; Up to 100 gms of intravenous vitamin C, three times per week for 10 weeks.

Outcome Measures

Primary Outcome Measures

1. Progression-free Survival [10 weeks]

Secondary Outcome Measures

1. Duration of Response [10 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jefferson-Myrna Brind Center of Integrative Medicine	Philadelphia	Pennsylvania	United States	19107

Sponsors and Collaborators

• Sidney Kimmel Cancer Center at Thomas Jefferson University

Investigators

• Principal Investigator: Daniel Monti, MD, Faculty Member

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sidney Kimmel Cancer Center at Thomas Jefferson University
• ClinicalTrials.gov Identifier: NCT00626444
• Other Study ID Numbers: 07U.21
• First Posted: Feb 29, 2008
• Last Update Posted: Nov 29, 2016
• Last Verified: Oct 1, 2016

• Additional relevant MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Ascorbic Acid

Study Results

Participant Flow

Arm/Group Title	Vitamin C
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

Baseline Characteristics

Arm/Group Title	Vitamin C
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 Participants	2
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	55.3 (2.9)
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	2 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	1 50%
Male	1 50%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	1 50%
More than one race	0 0%
Unknown or Not Reported	1 50%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 50%
Not Hispanic or Latino	1 50%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	2 100%

Outcome Measures

1. Primary Outcome

Title	Progression-free Survival
Time Frame	10 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Vitamin C
Arm/Group Description	Intravenous vitamin C Intravenous vitamin C: Up to 100 gms of intravenous vitamin C, three times per week for 10 weeks.
Measure Participants	0

2. Secondary Outcome

Title	Duration of Response
Time Frame	10 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Vitamin C
Arm/Group Description	Intravenous vitamin C Intravenous vitamin C: Up to 100 gms of intravenous vitamin C, three times per week for 10 weeks.
Measure Participants	0

Adverse Events

Arm/Group Title	Vitamin C
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 (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Vitamin C
	Affected / at Risk (%)	# Events
Total	0/2 (0%)
Other (Not Including Serious) Adverse Events
	Vitamin C
	Affected / at Risk (%)	# Events
Total	2/2 (100%)
General disorders
Abdominal pain	1/2 (50%)	1
Back pain	1/2 (50%)	1
Induration at IV site	1/2 (50%)	1
Lightheadedness	1/2 (50%)	1
Nausea	1/2 (50%)	1
Pain at IV site	1/2 (50%)	3
Viral illness	1/2 (50%)	1

Limitations/Caveats

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.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.