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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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13 May 2013 |
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Main ID: |
NCT00626444 |
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Date of registration:
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21/02/2008 |
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Primary sponsor: |
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Public title:
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Pilot Trial of Intravenous Vitamin C in Refractory Non-Hodgkin Lymphoma (NHL)
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Scientific title:
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Phase II Trial of High Dose Intravenous Vitamin C in Patients With Refractory Non-Hodgkin Lymphoma |
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Date of first enrolment:
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February 2008 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00626444 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Daniel Monti, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Faculty Member |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Non-Hodgkin Lymphoma
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Intervention(s)
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Drug: Intravenous vitamin C
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Primary Outcome(s)
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Progression-free survival
[Time Frame: 10 weeks]
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Secondary Outcome(s)
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Duration of response
[Time Frame: 10 weeks]
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Secondary ID(s)
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IND-77486
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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