LeukemiaPhase 2NCT00020969
Arsenic Trioxide in Treating Patients With Myelodysplastic Syndromes
A Phase 2 study testing arsenic trioxide in people with Leukemia and Myelodysplastic Syndromes, run by CTI BioPharma at 8 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. PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have myelodysplastic syndromes. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms
- What is being tested?
- arsenic trioxide
- How many people
- Not given
- Where
- 8 sitesUnited States
- Study dates
- Mar 2001to Jan 2005
- 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 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of myelodysplastic syndromes (MDS)
- Refractory anemia (RA)
- RA with ringed sideroblasts
- RA with excess blasts (RAEB)
- RAEB in transformation
- Chronic myelomonocytic leukemia
- Low-risk MDS patients:
- If serum erythropoietin less than 200 IU/mL, must have failed prior recombinant epoetin alfa (EPO) trial
- No prior acute myeloid leukemia
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 70-100%
Life expectancy:
- More than 3 months
Hematopoietic:
- Not specified
Hepatic:
- Bilirubin no greater than 2.5 times upper limit of normal (ULN)
- SGPT and SGOT no greater than 2.5 times ULN
Renal:
- Creatinine no greater than 1.5 times ULN
Cardiovascular:
- Absolute QT interval less than 460 msec in the presence of magnesium greater than 1.8 mg/dL and potassium greater than 4.0 mEq/L
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- See Disease Characteristics
- At least 30 days since prior biologic therapy (except recombinant EPO in low-risk MDS patients)
Chemotherapy:
- Not specified
Endocrine therapy:
- Not specified
Radiotherapy:
- At least 30 days since prior radiotherapy
Surgery:
- Not specified
Other:
- At least 30 days since prior cytotoxic agents
- At least 30 days since prior investigational agents
- No prior arsenic trioxide
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Georgia Cancer Specialists - Northside Office
Atlanta, Georgia, 30342
Lynn Regional Cancer Center West
Boca Raton, Florida, 33428
Corpus Christi Cancer Center
Corpus Christi, Texas, 78412
Green Cancer Center at Scripps Clinic
La Jolla, California, 92037-1027
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90033-0804
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1678
St. Joseph Hospital Regional Cancer Center - Orange
Orange, California, 92868-3849
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, 85724
About this study
Official title: Phase Two Multicenter Study Of Arsenic Trioxide In Patients With Myelodysplastic Syndromes
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 myelodysplastic syndromes.
Read the detailed description
OBJECTIVES:
- Determine the percentage of patients with low-risk myelodysplastic syndromes (MDS) who achieve a major hematologic improvement after treatment with arsenic trioxide.
- Determine the percentage of patients with high-risk MDS who achieve complete or partial remission or major hematological improvement after treatment with this drug.
- Determine the durability of responses in patients treated with this drug.
- Determine the duration of overall and progression-free survival of patients treated with this drug.
- Assess the quality of life of patients treated with this drug.
- Assess the toxicity profile of this drug in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to risk score (low risk vs high risk).
Patients receive arsenic trioxide IV 5 days a week on weeks 1-2. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with stable disease or better may receive additional courses of treatment. Patients who achieve a complete remission (CR) should receive 2 additional courses of treatment after documentation of CR.
Quality of life is assessed at baseline, every 8 weeks during study, and then at 4 weeks after study completion.
Patients are followed at 4 weeks, every 3 months until completion of study treatment, and then annually thereafter.
PROJECTED ACCRUAL: A total of 30-110 patients (15-55 per stratum) will be accrued for this study.
- Being tested
- arsenic trioxide
- Keywords
- refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, chronic myelomonocytic leukemia, de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes, atypical chronic myeloid leukemia, BCR-ABL1 negative, myelodysplastic/myeloproliferative neoplasm, unclassifiable
- Medical subject headings
- Leukemia, Myelodysplastic Syndromes, Myelodysplastic-Myeloproliferative Diseases, Anemia, Refractory, Anemia, Refractory, with Excess of Blasts, Leukemia, Myelomonocytic, Chronic, Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative, Myeloproliferative Disorders
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 posted27 Jan 2003 (estimated)
- Study startMar 2001
- Primary completionJan 2005
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
Sponsor and investigators
- Lead sponsor
- CTI BioPharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Scott C. Stromatt, MD, Study chair, CTI BioPharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00020969
- Sponsor's protocol ID
- CTI-1058
- Other IDs
- CDR0000068734, UCLA-HSPC-010104701, NCI-G01-1971
- Status last verified
- Oct 2020
- First submitted
- 11 Jul 2001
- Last updated
- 5 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Schiller GJ, Slack J, Hainsworth JD, Mason J, Saleh M, Rizzieri D, Douer D, List AF. Phase II multicenter study of arsenic trioxide in patients with myelodysplastic syndromes. J Clin Oncol. 2006 Jun 1;24(16):2456-64. doi: 10.1200/JCO.2005.03.7903. Epub 2006 May 1.
PubMed 16651647
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Two Multicenter Study Of Arsenic Trioxide In Patients With Myelodysplastic Syndromes
- ClinicalTrials.gov ID
- NCT00020969
- Acronym / sponsor ID
- CTI-1058
- Keywords
- refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, chronic myelomonocytic leukemia, de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Lead sponsor
- CTI BioPharmaIndustry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2001 (actual)
- Primary completion
- Jan 2005 (actual)
- Study completion
- Jan 2005 (actual)
- First posted
- 27 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.
PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have myelodysplastic syndromes.
Detailed description
OBJECTIVES:
- Determine the percentage of patients with low-risk myelodysplastic syndromes (MDS) who achieve a major hematologic improvement after treatment with arsenic trioxide.
- Determine the percentage of patients with high-risk MDS who achieve complete or partial remission or major hematological improvement after treatment with this drug.
- Determine the durability of responses in patients treated with this drug.
- Determine the duration of overall and progression-free survival of patients treated with this drug.
- Assess the quality of life of patients treated with this drug.
- Assess the toxicity profile of this drug in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to risk score (low risk vs high risk).
Patients receive arsenic trioxide IV 5 days a week on weeks 1-2. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with stable disease or better may receive additional courses of treatment. Patients who achieve a complete remission (CR) should receive 2 additional courses of treatment after documentation of CR.
Quality of life is assessed at baseline, every 8 weeks during study, and then at 4 weeks after study completion.
Patients are followed at 4 weeks, every 3 months until completion of study treatment, and then annually thereafter.
PROJECTED ACCRUAL: A total of 30-110 patients (15-55 per stratum) will be accrued for this study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 120 years
- 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 | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2020.
- Results publication: PubMed 16651647Schiller GJ, Slack J, Hainsworth JD, Mason J, Saleh M, Rizzieri D, Douer D, List AF. Phase II multicenter study of arsenic trioxide in patients with myelodysplastic syndromes. J Clin Oncol. 2006 Jun 1;24(16):2456-64. doi: 10.1200/JCO.2005.03.7903. Epub 2006 May 1.
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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.
Scott C. Stromatt, MD study chair
CTI BioPharma
8 sites 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 and Myelodysplastic Syndromes, run by CTI BioPharma at 8 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: stopped early, as of the sponsor's last update on 5 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 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 stopped early. Results are not available in the source record.
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?
On the ClinicalTrials.gov record for NCT00020969, 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 5 Oct 2020.