LeukemiaPhase 2NCT00005618
Arsenic Trioxide in Treating Patients With Relapsed or Refractory Chronic Myelogenous Leukemia
A Phase 2 study testing arsenic trioxide in people with Leukemia, run by Memorial Sloan Kettering Cancer Center at 1 site 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. PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have relapsed or refractory chronic myelogenous leukemia. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Leukemia
- What is being tested?
- arsenic trioxide
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Feb 2000to Mar 2004
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS: Chronic myelogenous leukemia (CML) confirmed by: Cytogenetic testing demonstrating presence of t(9:22) OR RT-PCR demonstrating presence of BCR/ABL rearrangement Chronic phase Blast count less than 15% OR Accelerated phase defined by 1 or more of the following: Blast count greater than 15% but less than 30% Blast count and promyelocytes greater than 30% Basophils greater than 20% Thrombocytopenia less than 100,000/mm3 not related to therapy Cytogenetic clonal evolution (13) OR Blastic phase Blast count greater than 30% OR Evidence of extramedullary blasts Relapse from or failure to achieve a major cytogenetic response to at least 1 course of standard anti-CML therapy including interferon alfa or cytotoxic chemotherapy Must have failed adequate trial of interferon alfa unless intolerance to or contraindication to interferon alfa Not eligible for allogeneic stem cell transplant
PATIENT CHARACTERISTICS: Age: Not specified Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) Renal: Creatinine no greater than 1.5 times ULN Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 4 months after study No active serious infections that are not controlled by antibiotics
PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics At least 4 weeks since prior interferon alfa Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy (1 day for hydroxyurea) No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No concurrent radiotherapy Surgery: Not specified Other: No other concurrent investigational agents
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
About this study
Official title: Phase II Study of Arsenic Trioxide, NSC 706363, in Relapsed of Refractory 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 relapsed or refractory chronic myelogenous leukemia.
Read the detailed description
OBJECTIVES: I. Determine the antileukemic efficacy of arsenic trioxide in patients with relapsed and/or refractory, chronic, accelerated, or blastic phase chronic myelogenous leukemia. II. Determine the pattern of clinical adverse experience in this patient population administered this drug.
OUTLINE: Patients are stratified according to disease stage (chronic phase vs accelerated phase or blastic phase). Patients receive arsenic trioxide IV over 1 hour on consecutive days or weekdays only for a total of 25 days followed by 3-5 weeks of rest. Treatment continues for a maximum of 6 courses in the absence of unacceptable toxicity or disease progression. Patients with responding disease are followed at least monthly.
PROJECTED ACCRUAL: A total of 10-27 patients will be accrued for the chronic phase stratum of this study within 2 years. A total of 17-37 patients will be accrued for the accelerated and blastic phases stratum of this study within 2 years.
- Conditions
- Leukemia
- Being tested
- arsenic trioxide
- Keywords
- relapsing chronic myelogenous leukemia, chronic phase chronic myelogenous leukemia, accelerated phase chronic myelogenous leukemia, blastic phase chronic myelogenous leukemia
- Medical subject headings
- Leukemia, Leukemia, Myeloid, Chronic-Phase, Leukemia, Myeloid, Accelerated Phase, Blast Crisis
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 posted2 Apr 2004 (estimated)
- Study startFeb 2000
- Study completionMar 2004
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 Memorial Sloan Kettering 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
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- David A. Scheinberg, MD, PhD, Study chair, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005618
- Sponsor's protocol ID
- CDR0000067755
- Other IDs
- MSKCC-99076A, NCI-190
- Status last verified
- Oct 2001
- First submitted
- 2 May 2000
- Last updated
- 21 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Arsenic Trioxide, NSC 706363, in Relapsed of Refractory Chronic Myelogenous Leukemia
- ClinicalTrials.gov ID
- NCT00005618
- Acronym / sponsor ID
- CDR0000067755
- Conditions
- Leukemia
- Keywords
- relapsing chronic myelogenous leukemia, chronic phase chronic myelogenous leukemia, accelerated phase chronic myelogenous leukemia, blastic phase chronic myelogenous leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2000
- Study completion
- Mar 2004 (actual)
- First posted
- 2 Apr 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 relapsed or refractory chronic myelogenous leukemia.
Detailed description
OBJECTIVES: I. Determine the antileukemic efficacy of arsenic trioxide in patients with relapsed and/or refractory, chronic, accelerated, or blastic phase chronic myelogenous leukemia. II. Determine the pattern of clinical adverse experience in this patient population administered this drug.
OUTLINE: Patients are stratified according to disease stage (chronic phase vs accelerated phase or blastic phase). Patients receive arsenic trioxide IV over 1 hour on consecutive days or weekdays only for a total of 25 days followed by 3-5 weeks of rest. Treatment continues for a maximum of 6 courses in the absence of unacceptable toxicity or disease progression. Patients with responding disease are followed at least monthly.
PROJECTED ACCRUAL: A total of 10-27 patients will be accrued for the chronic phase stratum of this study within 2 years. A total of 17-37 patients will be accrued for the accelerated and blastic phases stratum of this study within 2 years.
Study design
- Primary purpose
- Treatment
Who may qualify
- 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 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 21 Jun 2013.
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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.
David A. Scheinberg, MD, PhD study chair
Memorial Sloan Kettering Cancer Center
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 Leukemia, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2013. 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?
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.
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 21 Jun 2013.