LeukemiaPhase 2NCT00006091
Arsenic Trioxide in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia That Has Not Responded to Previous Treatment
A Phase 2 study testing arsenic trioxide in people with Leukemia, run by M.D. Anderson Cancer Center.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have chronic phase chronic myelogenous leukemia that has not responded to previous treatment. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Leukemia
- What is being tested?
- arsenic trioxide
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 19 Jun 2000to Jan 2002
- Phase
- Phase 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of Philadelphia (Ph) chromosome positive (or breakpoint cluster region bcr positive) chronic myelogenous leukemia in chronic phase
- Ineligible for or refused allogeneic bone marrow transplantation
- Interferon alfa refractory or intolerant as defined by the following:
- Refractory: Failure to achieve a complete hematologic response lasting for at least 1 month after prior therapy with interferon alfa based regimen for at least 3 months 65% or more Ph positive chromosomes in bone marrow after one year of interferon alfa based therapy
- At least a 30% increase in Ph positive chromosomes in bone marrow in samples taken at least one month apart OR
- An increase of at least 65% in Ph positive chromosomes in bone marrow
- Intolerant: Grade 3 or greater nonhematologic toxicity Autoimmune phenomenon at any grade
- No accelerated phase or blastic phase disease as defined by the following:
- Greater than 15% blasts or basophils in the peripheral blood or bone marrow
- Greater than 30% blasts plus promyelocytes in the peripheral blood or bone marrow
- Documented extramedullary blastic disease outside liver or spleen
- Platelet count less than 100,000/mm3 unrelated to therapy
- Clonal evolution (additional chromosomal abnormalities other than Ph chromosome) as solitary feature is not considered accelerated disease
- No known brain metastases or central nervous system (CNS) disease
PATIENT CHARACTERISTICS:
- Age: 12 and over
- Performance status: Zubrod 0-2
- Life expectancy: At least 2 years
- Hematopoietic: See Disease Characteristics
- Hepatic: Unless due to direct disease infiltration of the liver:
- ALT and AST no greater than 2.5 times upper limit of normal (ULN)
- Bilirubin no greater than 1.5 times ULN (unless due to Gilbert's disease)
- No hepatic disease that would preclude study
- Renal: Creatinine no greater than 1.5 times ULN Creatinine clearance at least 60 mL/min
- Cardiovascular: No history of New York Heart Association grade III or IV cardiac disease
- No cardiovascular disease that would preclude study
- No unstable angina pectoris or cardiac arrhythmia that would shorten life expectancy
- Other: No history of grand mal seizures other than infantile febrile seizures
- No active secondary malignancy or other uncontrolled concurrent medical problem that would shorten life expectancy
- No neurologic, endocrine, or other major systemic disease that would preclude study
- No active infection uncontrolled by oral or IV antibiotics
- No history of hypersensitivity to the study drug or drugs with similar chemical structure
- No mental condition that would preclude study Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
- Biologic therapy: See Disease Characteristics
- No concurrent bone marrow or peripheral blood stem cell transplantation
- Chemotherapy: At least 14 days since prior chemotherapy (48 hours for hydroxyurea and 6 weeks for busulfan) and recovered (unless evidence of rapidly progressive disease)
- No other concurrent cytotoxic chemotherapy
- No prior arsenic trioxide
- Endocrine therapy: No concurrent steroids for the treatment of neoplasms (except for new adrenal failures)
- No concurrent hormones for the treatment of neoplasms (except for nondisease related conditions)
- Radiotherapy: At least 14 days since prior radiotherapy
- No concurrent radiotherapy
- Surgery: Not specified
- Other: At least 14 days since other prior investigational agent
- No other concurrent investigational or antileukemic agents
About this study
Official title: Arsenic Trioxide Therapy for Interferon Alpha Refractory or Intolerant Chronic Phase Chronic Myelogenous Leukemia
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have chronic phase chronic myelogenous leukemia that has not responded to previous treatment.
Read the detailed description
OBJECTIVES:
- Determine the rate of complete or major cytogenetic response to arsenic trioxide as demonstrated by a decrease in the percentage of Philadelphia chromosome positive (or breakpoint cluster region bcr positive) cells in the bone marrow in patients with interferon alfa refractory or intolerant chronic phase chronic myelogenous leukemia.
II. Determine the rate and duration of complete hematological response to this treatment in these patients.
III. Determine the duration of complete and major cytogenetic response to this treatment in these patients.
IV. Determine the pattern of clinical adverse experience and improvement in symptomatic parameters with this treatment in these patients.
- Determine the time to accelerated disease or blast crisis and overall survival in these patients after receiving this treatment.
VI. Determine the effects of this treatment on cytokines, apoptosis, and angiogenesis in these patients.
OUTLINE: Patients receive arsenic trioxide intravenous (IV) over 2 hours either daily for 15 consecutive days or 5 days on, 2 days off for a total of 15 doses. Treatment repeats every 2-5 weeks after the previous course for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity. Patients achieving complete remission are followed every month for 3 months, every 2 months for 6 months, every 3-4 months for 1 year, and then every 6 months thereafter. All other patients are followed every 3 months for 1 year and then annually thereafter.
PROJECTED ACCRUAL: A total of 17-53 patients will be accrued for this study within 2.5 years.
- Conditions
- Leukemia
- Being tested
- arsenic trioxide
- Keywords
- relapsing chronic myelogenous leukemia, chronic phase chronic myelogenous leukemia, chronic myelogenous leukemia, BCR-ABL1 positive
- 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2004 (estimated)
- Study start19 Jun 2000
- Primary completionJan 2002
- Study completionJan 2002
Why it stopped: No enrollment.
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 M.D. Anderson Cancer CenterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Deborah A. Thomas, MD, Study chair, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006091
- Sponsor's protocol ID
- CDR0000068094
- Other IDs
- MDA-DM-00058, NCI-311, ID00-058
- Status last verified
- Nov 2018
- First submitted
- 3 Aug 2000
- Last updated
- 14 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arsenic Trioxide Therapy for Interferon Alpha Refractory or Intolerant Chronic Phase Chronic Myelogenous Leukemia
- ClinicalTrials.gov ID
- NCT00006091
- Acronym / sponsor ID
- CDR0000068094
- Conditions
- Leukemia
- Keywords
- relapsing chronic myelogenous leukemia, chronic phase chronic myelogenous leukemia, chronic myelogenous leukemia, BCR-ABL1 positive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No enrollment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 19 Jun 2000 (actual)
- Primary completion
- Jan 2002 (actual)
- Study completion
- Jan 2002 (actual)
- First posted
- 16 Mar 2004 (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.
PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have chronic phase chronic myelogenous leukemia that has not responded to previous treatment.
Detailed description
OBJECTIVES:
- Determine the rate of complete or major cytogenetic response to arsenic trioxide as demonstrated by a decrease in the percentage of Philadelphia chromosome positive (or breakpoint cluster region bcr positive) cells in the bone marrow in patients with interferon alfa refractory or intolerant chronic phase chronic myelogenous leukemia.
II. Determine the rate and duration of complete hematological response to this treatment in these patients.
III. Determine the duration of complete and major cytogenetic response to this treatment in these patients.
IV. Determine the pattern of clinical adverse experience and improvement in symptomatic parameters with this treatment in these patients.
- Determine the time to accelerated disease or blast crisis and overall survival in these patients after receiving this treatment.
VI. Determine the effects of this treatment on cytokines, apoptosis, and angiogenesis in these patients.
OUTLINE: Patients receive arsenic trioxide intravenous (IV) over 2 hours either daily for 15 consecutive days or 5 days on, 2 days off for a total of 15 doses. Treatment repeats every 2-5 weeks after the previous course for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity. Patients achieving complete remission are followed every month for 3 months, every 2 months for 6 months, every 3-4 months for 1 year, and then every 6 months thereafter. All other patients are followed every 3 months for 1 year and then annually thereafter.
PROJECTED ACCRUAL: A total of 17-53 patients will be accrued for this study within 2.5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2018.
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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.
Deborah A. Thomas, MD study chair
M.D. Anderson Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing arsenic trioxide in people with Leukemia, run by M.D. Anderson Cancer Center.
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: withdrawn, as of the sponsor's last update on 14 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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.
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 14 Nov 2018.