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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.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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:

  1. 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.

  1. 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.

  1. First posted16 Mar 2004 (estimated)
  2. Study start19 Jun 2000
  3. Primary completionJan 2002
  4. Study completionJan 2002

Why it stopped: No enrollment.

Resources

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)
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

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.

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