Cancer Other Than LeukemiaPhase 2NCT01428128
Low Dose Arsenic Trioxide as a Potential Chemotherapy Protector
A Phase 2 study testing Arsenic Trioxide in people with Cancer Other Than Leukemia, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Other Than Leukemia
- What is being tested?
- Arsenic Trioxide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Jan 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥ 18 years of age with the diagnosis of malignancy other than leukemia who are to start chemotherapy known to suppress peripheral blood counts. The expected interval between each cycle of chemotherapy should be a minimum of 2 weeks. The minimum number of planned chemotherapy cycles should be 4. Radiation therapy during chemotherapy is allowed as long as less than 10% of the total bone marrow is radiated.
- Present with or without previous treatment for the disease.
- ECOG (Eastern Cooperative Oncology Group) performance status </= 2 (see Appendix B).
- Life expectancy of greater than 6 months
- Organ functions as deemed appropriate for chemotherapy per standard of care
- Agree to use adequate contraception prior to study entry and for the duration of study participation.
- Ability to understand and the willingness to sign a written informed consent document.
- No baseline p53 activation in peripheral lymphocytes in culture but p53 activation should be inducible upon radiation with 2 Gy in culture
Who cannot join
- History of allergic reactions attributed to Arsenic Trioxide
- Experiencing uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant
- HIV-positive patients and taking combination antiretroviral therapy.
- History of having circulating malignant cells if the patient has lymphoma or myeloma
- Impaired cardiac function or clinically significant cardiac diseases, including any of the following: history of long QT syndrome; mean QTc (corrected QT interval) > 500 msec on screening EKG; history of clinically manifest ischemic heart disease including myocardial infarction; stable or unstable angina, coronary arteriography or cardiac stress testing/imaging with findings consistent with coronary occlusion or infarction < 6 months prior to study start; history of heart failure or left ventricular (LV) dysfunction (LVEF < 45%) by MUGA or ECHO; clinically significant EKG abnormalities including one or more of the following: left bundle branch block (LBBB), right bundle branch block (RBBB) with left anterior hemiblock (LAHB). ST segment elevations or depressions > lmm, or 2nd (Mobitz 11) or 3rd degree AV block; history or presence of atrial fibrillation, atrial flutter or ventricular arrhythmias including ventricular tachycardia or Torsades de Pointes; other clinically significant heart disease (e.g. congestive heart failure, uncontrolled hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen); clinically significant resting bradycardia (< 50 beats per minute); obligate use of a cardiac pacemaker.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
About this study
Official title: A Phase II Study of Low Dose Arsenic Trioxide in Patients With Malignancies 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) 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.
Read more
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.
- Conditions
- Cancer Other Than Leukemia
- Being tested
- Arsenic Trioxide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arsenic TrioxideDrug
Also called Brand name: Trisonex
IV; 0.005mg/kg. Infusion on Days -3, -2 and -1 of Chemo Cycles 2, 4, and 6 (if more than 4 cycles received).
| Study group | Role | What they receive |
|---|---|---|
| Arsenic Trioxide | Experimental | Not described Receives: Drug: Arsenic Trioxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose of Arsenic That Blocks Activation of p53
A main objective of this trial is to find the dose of arsenic that blocks the activation of p53. Blockage will reduce the amount of p53 production as measured by Western Blot.
Measured: Day 1 of chemotherapy
Secondary outcomes (1)
Complete Blood Count (CBC)
Another objective of this trial is to assess if arsenic protects the blood counts that are adversely affected by chemotherapy
Measured: Day 9 of chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2011 (estimated)
- Study startApr 2011
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer Other Than LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center at San Antonio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chul S. Ha, M.D., Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01428128
- Sponsor's protocol ID
- HSC20110177H
- Status last verified
- Nov 2017
- First submitted
- 17 Jun 2011
- Last updated
- 13 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Ha CS, Michalek JE, Elledge R, Kelly KR, Ganapathy S, Su H, Jenkins CA, Argiris A, Swords R, Eng TY, Karnad A, Crownover RL, Swanson GP, Goros M, Pollock BH, Yuan ZM. p53-based strategy to reduce hematological toxicity of chemotherapy: A proof of principle study. Mol Oncol. 2016 Jan;10(1):148-56. doi: 10.1016/j.molonc.2015.09.004. Epub 2015 Sep 18.
PubMed 26440706
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Low Dose Arsenic Trioxide in Patients With Malignancies as a Potential Chemotherapy Protector
- ClinicalTrials.gov ID
- NCT01428128
- Acronym / sponsor ID
- HSC20110177H
- Conditions
- Cancer Other Than Leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 2 Sep 2011 (estimated)
- Results
- Posted 18 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arsenic Trioxide | Experimental | Drug: Arsenic Trioxide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients ≥ 18 years of age with the diagnosis of malignancy other than leukemia who are to start chemotherapy known to suppress peripheral blood counts. The expected interval between each cycle of chemotherapy should be a minimum of 2 weeks. The minimum number of planned chemotherapy cycles should be 4. Radiation therapy during chemotherapy is allowed as long as less than 10% of the total bone marrow is radiated.
- Present with or without previous treatment for the disease.
- ECOG (Eastern Cooperative Oncology Group) performance status </= 2 (see Appendix B).
- Life expectancy of greater than 6 months
- Organ functions as deemed appropriate for chemotherapy per standard of care
Key exclusion criteria (6 listed)
- History of allergic reactions attributed to Arsenic Trioxide
- Experiencing uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant
- HIV-positive patients and taking combination antiretroviral therapy.
- History of having circulating malignant cells if the patient has lymphoma or myeloma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arsenic TrioxideAlso: Brand name: TrisonexIV; 0.005mg/kg. Infusion on Days -3, -2 and -1 of Chemo Cycles 2, 4, and 6 (if more than 4 cycles received). | Drug | Arsenic Trioxide |
Primary outcome
Dose of Arsenic That Blocks Activation of p53
Time frame: Day 1 of chemotherapy
A main objective of this trial is to find the dose of arsenic that blocks the activation of p53. Blockage will reduce the amount of p53 production as measured by Western Blot.
1 secondary outcome
Complete Blood Count (CBC)
Time frame: Day 9 of chemotherapy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26440706Ha CS, Michalek JE, Elledge R, Kelly KR, Ganapathy S, Su H, Jenkins CA, Argiris A, Swords R, Eng TY, Karnad A, Crownover RL, Swanson GP, Goros M, Pollock BH, Yuan ZM. p53-based strategy to reduce hematological toxicity of chemotherapy: A proof of principle study. Mol Oncol. 2016 Jan;10(1):148-56. doi: 10.1016/j.molonc.2015.09.004. Epub 2015 Sep 18.
Related trials for Cancer Other Than Leukemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chul S. Ha, M.D. principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Arsenic Trioxide in people with Cancer Other Than Leukemia, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose of Arsenic That Blocks Activation of p53 (time frame: Day 1 of chemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01428128, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2017.