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NCT00626444 · ClinicalTrials.gov registry record · Phase 2
Pilot Trial of Intravenous Vitamin C in Refractory Non-Hodgkin Lymphoma (NHL)
A Phase 2 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 2
- Enrollment target
NCT00626444 is a Phase 2 study that was terminated before completion, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University. The registered enrollment target is 2 participants.
The verdict
NCT00626444, a Phase 2 study, was terminated before completion, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 2 participants
- Enrollment target
Study 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.
Interventions
- DRUG Intravenous vitamin C
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2008-02 |
| Est. Completion | 2011-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00626444
The ClinicalTrials.gov registry entry for NCT00626444 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University, which has 138 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Intravenous vitamin C is the first listed.
NCT00626444 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00626444 about?
NCT00626444 is a clinical study titled "Pilot Trial of Intravenous Vitamin C in Refractory Non-Hodgkin Lymphoma (NHL)". 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...
What is the current status of trial NCT00626444?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 2 participants. The study started on 2008-02. Estimated completion is 2011-12.
What interventions are being tested in trial NCT00626444?
The interventions under investigation include: Intravenous vitamin C (DRUG).
Who is sponsoring clinical trial NCT00626444?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University, which has 138 total clinical trials registered on ClinicalTrials.gov.
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