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NCT01428128 · ClinicalTrials.gov registry record · Phase 2
Low Dose Arsenic Trioxide as a Potential Chemotherapy Protector
A Phase 2 study, sponsored by The University of Texas Health Science Center at San Antonio.
- Completed
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
NCT01428128 is a Phase 2 study that has completed, run by The University of Texas Health Science Center at San Antonio. The registered enrollment target is 50 participants.
The verdict
NCT01428128, a Phase 2 study, has completed, sponsored by The University of Texas Health Science Center at San Antonio.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
Study Summary
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 investiga
Interventions
- DRUG Arsenic Trioxide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2011-04 |
| Est. Completion | 2013-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01428128
The ClinicalTrials.gov registry entry for NCT01428128 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The University of Texas Health Science Center at San Antonio, which has 378 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Arsenic Trioxide is the first listed.
NCT01428128 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01428128 about?
NCT01428128 is a clinical study titled "Low Dose Arsenic Trioxide as a Potential Chemotherapy Protector". 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)...
What is the current status of trial NCT01428128?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2011-04. Estimated completion is 2013-01.
What interventions are being tested in trial NCT01428128?
The interventions under investigation include: Arsenic Trioxide (DRUG).
Who is sponsoring clinical trial NCT01428128?
This trial is sponsored by The University of Texas Health Science Center at San Antonio, which has 378 total clinical trials registered on ClinicalTrials.gov.
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