Low Dose Arsenic Trioxide as a Potential Chemotherapy Protector
Public ClinicalTrials.gov record NCT01428128. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase II Study of Low Dose Arsenic Trioxide in Patients With Malignancies as a Potential Chemotherapy Protector
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Many types of cancer are treated with chemotherapy drugs and/or radiation therapy. These forms of treatment, however, can also damage normal (non-cancer) cells and cause a variety of side effects. There are many side effects of chemotherapy. A few examples are: lowered red blood cell counts (anemia) which can lead to tiredness, weakness or shortness of breath; lowered white cell counts (white blood cells which help the body to fight infection); low platelet counts (platelets help blood to clot); nausea and vomiting; diarrhea; lip and mouth sores and hair loss. These side effects can range from mild to severe. P53 is a protein in the body that regulates the cell cycle. If a cell becomes damaged from chemotherapy or radiation treatment, the p53 protein becomes activated. This activation can cause the cell to die and is involved in causing side effects from chemotherapy or radiation therapy. Arsenic trioxide is a drug that is currently approved by the FDA (Food and Drug Administration) for the treatment of acute promyelocytic leukemia (APL), which is a type of blood and bone marrow cancer. It is given by I.V (intravenous, by vein). New preclinical studies have shown that when given in smaller than normal doses before treatment with chemotherapy and/or radiation therapy, the arsenic trioxide can block the activation of p53 and protect normal tissues from treatment damage. Preclinical means that the studies have been done in a laboratory and not on humans. This study has two purposes. The first is to find the dose range for arsenic trioxide that will block p53 activity. This dose has been determined from the first five subjects who took part in the study and received arsenic trioxide. The dose of arsenic trioxide for this study is about 1/30 of the normal dose given when arsenic trioxide is used to treat acute promyelocytic leukemia. The second is to see if the arsenic trioxide will decrease the side effects of chemotherapy. In this study, arsenic trioxide is investigational. "Investigational" means that arsenic trioxide has not yet been approved by the FDA to block p53 activity. This study will help find out what the smallest (best) dose is that can be given and the effects, good and/or bad, this drug has on people who take it. The safety of this drug in humans has been tested in prior research studies; however, whether the side effects will still be present at this lower dose is not yet known.
Study identification
- NCT ID
- NCT01428128
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 50 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 31, 2011
- Primary completion
- Dec 31, 2012
- Completion
- Dec 31, 2012
- Last update posted
- Dec 12, 2017
2011 – 2013
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| The University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01428128, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 12, 2017 · Synced Sep 10, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01428128 live on ClinicalTrials.gov.