LeukemiaPhase 1/2NCT00053248
Arsenic Trioxide and Imatinib Mesylate in Treating Patients With Chronic Myelogenous Leukemia
A Phase 1/2 study testing arsenic trioxide and imatinib mesylate in people with Leukemia, run by OHSU Knight Cancer Institute at 3 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Combining chemotherapy with imatinib mesylate may kill more cancer cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia
- What is being tested?
- arsenic trioxide and imatinib mesylate
- How many people
- 16 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2002to Jun 2005
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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
DISEASE CHARACTERISTICS:
- Cytogenetically confirmed Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia, meeting one of the following criteria:
- Chronic phase
- Less than 15% blasts in peripheral blood or marrow
- Less than 30% blasts and promyelocytes in peripheral blood or marrow
- Less than 20% basophils in blood or marrow
- Platelet count at least 100,000/mm^3 (unless therapy related)
- No progressive (increase of at least 10 cm in any 4 of the past 24 weeks) or existing (greater than 10 cm) splenomegaly
- Complete hematologic response (CHR)
- No immature myeloid cells in peripheral blood
- No increased basophils in peripheral blood
- WBC less than upper limit of normal (ULN)
- Platelet count less than ULN
- No major (less than 35% Ph+) or complete (0% Ph+) cytogenetic response after at least 6 months of imatinib mesylate
- Loss of prior major cytogenetic response or failure to achieve major cytogenetic response
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- Not specified
Hematopoietic
- See Disease Characteristics
Hepatic
- Bilirubin less than 1.5 times ULN
- AST or ALT less than 2.5 times ULN
Renal
- Creatinine less than 1.5 times ULN
Cardiovascular
- No New York Heart Association grade III or IV congestive heart failure
- No untreated symptomatic cardiac ischemia
- No underlying cardiac arrhythmia, including but not limited to any of the following:
- Conduction abnormality/atrioventricular heart block
- Nodal/junctional arrhythmia/dysrhythmia
- Sinus bradycardia or tachycardia
- Supraventricular tachycardia
- Ventricular arrhythmia
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use 2 methods of effective barrier contraception during and for 3 months after study
- Electrolyte levels (especially potassium and magnesium) normal (CHR patients)
- No history of noncompliance that would preclude study participation
- No other concurrent serious, uncontrolled medical condition
- No grade 2 or greater neuropathy
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- More than 14 days since prior therapy except hydroxyurea, anagrelide hydrochloride, or imatinib mesylate
- More than 28 days since prior investigational agents
- No concurrent grapefruit or grapefruit juice
Trial locations and contacts
3 sites in 1 country.
United States3 sites
UCLA Department of Medicine, Division of Hematology/Oncology
Los Angeles, California, 90095
OHSU Knight Cancer Institute
Portland, Oregon, 97239
H. Lee Moffitt Cancer Center
Tampa, Florida, 33612
About this study
Official title: A Phase I/II Study To Determine The Safety, Tolerability, And Anti-Leukemic Effects of Trisenox (Arsenic Trioxide) In Combination With Gleevec (STI571) In Patients With Resistant Chronic Myelogenous Leukemia In Chronic Phase
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Combining chemotherapy with imatinib mesylate may kill more cancer cells.
PURPOSE: Phase I/II trial to study the effectiveness of combining arsenic trioxide with imatinib mesylate in treating patients who have chronic phase chronic myelogenous leukemia.
Read the detailed description
OBJECTIVES:
- Determine the safety and tolerability of arsenic trioxide and imatinib mesylate in patients with resistant chronic phase chronic myelogenous leukemia.
- Determine potential dose-limiting toxic effects in patients treated with this regimen.
- Determine the pharmacokinetics of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral imatinib mesylate once daily and arsenic trioxide IV over 1-2 hours on days 1-5 of week 1 and then twice weekly. Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 18-24 patients (at least 6 patients for phase I and at least 12 patients for phase II) will be accrued for this study .
- Conditions
- Leukemia
- Being tested
- arsenic trioxide, imatinib mesylate
- Keywords
- chronic phase chronic myelogenous leukemia, Philadelphia chromosome positive chronic myelogenous leukemia
- Medical subject headings
- Leukemia, Leukemia, Myeloid, Chronic-Phase, Leukemia, Myelogenous, Chronic, BCR-ABL Positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arsenic trioxideDrug
imatinib mesylateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Satey and Tolerability
Dose-limiting toxicity
Pharmacokinetics
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2003 (estimated)
- Study startOct 2002
- Primary completionJun 2005
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by OHSU Knight Cancer InstituteThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Michael Mauro, MD, Principal investigator, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00053248
- Sponsor's protocol ID
- CDR0000269319
- Other IDs
- OHSU-UCLA-0206062, OHSU-HEM-02001-L, OHSU-1096
- Status last verified
- Jun 2010
- First submitted
- 27 Jan 2003
- Last updated
- 28 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study To Determine The Safety, Tolerability, And Anti-Leukemic Effects of Trisenox (Arsenic Trioxide) In Combination With Gleevec (STI571) In Patients With Resistant Chronic Myelogenous Leukemia In Chronic Phase
- ClinicalTrials.gov ID
- NCT00053248
- Acronym / sponsor ID
- CDR0000269319
- Conditions
- Leukemia
- Keywords
- chronic phase chronic myelogenous leukemia, Philadelphia chromosome positive chronic myelogenous leukemia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2002
- Primary completion
- Jun 2005 (actual)
- Study completion
- Jun 2005 (actual)
- First posted
- 28 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Combining chemotherapy with imatinib mesylate may kill more cancer cells.
PURPOSE: Phase I/II trial to study the effectiveness of combining arsenic trioxide with imatinib mesylate in treating patients who have chronic phase chronic myelogenous leukemia.
Detailed description
OBJECTIVES:
- Determine the safety and tolerability of arsenic trioxide and imatinib mesylate in patients with resistant chronic phase chronic myelogenous leukemia.
- Determine potential dose-limiting toxic effects in patients treated with this regimen.
- Determine the pharmacokinetics of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral imatinib mesylate once daily and arsenic trioxide IV over 1-2 hours on days 1-5 of week 1 and then twice weekly. Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 18-24 patients (at least 6 patients for phase I and at least 12 patients for phase II) will be accrued for this study .
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 trioxide | Drug | – |
| imatinib mesylate | Drug | – |
Primary outcome
Satey and Tolerability
Dose-limiting toxicity
Pharmacokinetics
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2012.
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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.
Michael Mauro, MD principal investigator
OHSU Knight Cancer Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing arsenic trioxide and imatinib mesylate in people with Leukemia, run by OHSU Knight Cancer Institute at 3 sites 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?
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 28 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Satey and Tolerability. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 May 2012.