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Arsenic Trioxide in Treating Patients With Myelodysplastic Syndromes

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ClinicalTrials.gov Identifier: NCT00020969
Recruitment Status : Terminated
First Posted : January 27, 2003
Last Update Posted : October 5, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
CTI BioPharma

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasms Drug: arsenic trioxide Phase 2

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
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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Phase Two Multicenter Study Of Arsenic Trioxide In Patients With Myelodysplastic Syndromes
Actual Study Start Date : March 2001
Actual Primary Completion Date : January 2005
Actual Study Completion Date : January 2005

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00020969


Locations
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United States, Arizona
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, United States, 85724
United States, California
Green Cancer Center at Scripps Clinic
La Jolla, California, United States, 92037-1027
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90033-0804
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1678
St. Joseph Hospital Regional Cancer Center - Orange
Orange, California, United States, 92868-3849
United States, Florida
Lynn Regional Cancer Center West
Boca Raton, Florida, United States, 33428
United States, Georgia
Georgia Cancer Specialists - Northside Office
Atlanta, Georgia, United States, 30342
United States, Texas
Corpus Christi Cancer Center
Corpus Christi, Texas, United States, 78412
Sponsors and Collaborators
CTI BioPharma
National Cancer Institute (NCI)
Investigators
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Study Chair: Scott C. Stromatt, MD CTI BioPharma
More Information
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Publications of Results:

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Responsible Party: CTI BioPharma
ClinicalTrials.gov Identifier: NCT00020969    
Other Study ID Numbers: CTI-1058
CDR0000068734 ( Registry Identifier: PDQ (Physician Data Query) )
UCLA-HSPC-010104701
NCI-G01-1971
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: October 5, 2020
Last Verified: October 2020
Keywords provided by CTI BioPharma:
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
Additional relevant MeSH terms:
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Leukemia
Preleukemia
Myelodysplastic Syndromes
Myeloproliferative Disorders
Myelodysplastic-Myeloproliferative Diseases
Syndrome
Disease
Pathologic Processes
 Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Arsenic Trioxide
Antineoplastic Agents