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Arsenic Trioxide in Treating Patients With Myelodysplastic Syndromes

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ClinicalTrials.gov Identifier: NCT00020969
Recruitment Status : Unknown
Verified September 2004 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : May 13, 2011
Sponsor:
Collaborator:
Information provided by:

Study Description
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

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


Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

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
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
Study Chair: Scott C. Stromatt, MD CTI BioPharma
More Information

Publications:
ClinicalTrials.gov Identifier: NCT00020969     History of Changes
Other Study ID Numbers: CDR0000068734
CTI-1058
UCLA-HSPC-010104701
NCI-G01-1971
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: May 13, 2011
Last Verified: September 2004

Keywords provided by National Cancer Institute (NCI):
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:
Syndrome
Leukemia
Myelodysplastic Syndromes
Preleukemia
Myeloproliferative Disorders
Myelodysplastic-Myeloproliferative Diseases
Disease
Pathologic Processes
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Arsenic trioxide
Antineoplastic Agents