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Arsenic Trioxide in Treating Patients With Myelodysplastic Syndromes
This study is ongoing, but not recruiting participants.
First Received: July 11, 2001   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: Cell Therapeutics
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00020969
  Purpose

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 Intervention Phase
Leukemia
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Diseases
 Drug: arsenic trioxide
 Phase II

Study Type: Interventional
Study Design: Treatment
Official Title: Phase Two Multicenter Study Of Arsenic Trioxide In Patients With Myelodysplastic Syndromes

Resource links provided by NLM:

MedlinePlus related topics: Anemia Arsenic Cancer Leukemia, Adult Acute Leukemia, Adult Chronic
Drug Information available for: Arsenic trioxide
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: March 2001
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
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
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90033-0804
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
Cell Therapeutics
National Cancer Institute (NCI)
Investigators
Study Chair: Scott C. Stromatt, MD Cell Therapeutics
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

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. Epub 2006 May 1.

Study ID Numbers: CDR0000068734, CTI-1058, UCLA-HSPC-010104701, NCI-G01-1971
Study First Received: July 11, 2001
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00020969     History of Changes
Health Authority: United States: Federal Government

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
myelodysplastic/myeloproliferative disease, unclassifiable

Study placed in the following topic categories:
Chronic Myelomonocytic Leukemia
Precancerous Conditions
Hematologic Diseases
Leukemia, Myelomonocytic, Chronic
Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative
Myelodysplastic Syndromes
Anemia
Myeloproliferative Disorders
Arsenic trioxide
Leukemia, Myeloid
Refractory Anemia
 Leukemia
Preleukemia
Anemia, Refractory
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasm Metastasis
Chronic Myelogenous Leukemia
Anemia, Refractory, with Excess of Blasts
Bone Marrow Diseases
Myelodysplastic-Myeloproliferative Diseases
Myelodysplastic Myeloproliferative Disease

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Disease
Precancerous Conditions
Antineoplastic Agents
Hematologic Diseases
Myelodysplastic Syndromes
Myeloproliferative Disorders
Arsenic trioxide
Pharmacologic Actions
 Leukemia
Preleukemia
Neoplasms
Pathologic Processes
Therapeutic Uses
Syndrome
Myelodysplastic-Myeloproliferative Diseases
Bone Marrow Diseases

ClinicalTrials.gov processed this record on July 02, 2009



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