NCT00020969

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Mar 2001

Geographic Reach
1 country

8 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2001

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2001

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
Last Updated

October 5, 2020

Status Verified

October 1, 2020

Enrollment Period

3.8 years

First QC Date

July 11, 2001

Last Update Submit

October 2, 2020

Conditions

LeukemiaMyelodysplastic SyndromesMyelodysplastic/Myeloproliferative Neoplasms

Keywords

refractory anemiarefractory anemia with ringed sideroblastsrefractory anemia with excess blastsrefractory anemia with excess blasts in transformationchronic myelomonocytic leukemiade novo myelodysplastic syndromespreviously treated myelodysplastic syndromessecondary myelodysplastic syndromesatypical chronic myeloid leukemia, BCR-ABL1 negativemyelodysplastic/myeloproliferative neoplasm, unclassifiable

Interventions

arsenic trioxideDRUG

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (8)

Arizona Cancer Center at University of Arizona Health Sciences Center

Tucson, Arizona, 85724, United States

Location

Green Cancer Center at Scripps Clinic

La Jolla, California, 92037-1027, United States

Location

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90033-0804, United States

Location

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1678, United States

Location

St. Joseph Hospital Regional Cancer Center - Orange

Orange, California, 92868-3849, United States

Location

Lynn Regional Cancer Center West

Boca Raton, Florida, 33428, United States

Location

Georgia Cancer Specialists - Northside Office

Atlanta, Georgia, 30342, United States

Location

Corpus Christi Cancer Center

Corpus Christi, Texas, 78412, United States

Location

Related Publications (1)

  • 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.

    PMID: 16651647RESULT

MeSH Terms

Conditions

LeukemiaMyelodysplastic SyndromesMyelodysplastic-Myeloproliferative DiseasesAnemia, RefractoryAnemia, Refractory, with Excess of BlastsLeukemia, Myelomonocytic, ChronicLeukemia, Myeloid, Chronic, Atypical, BCR-ABL NegativeMyeloproliferative Disorders

Interventions

Arsenic Trioxide

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesBone Marrow DiseasesAnemiaLeukemia, MyeloidChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ArsenicalsInorganic ChemicalsOxidesOxygen Compounds

Study Officials

  • Scott C. Stromatt, MD

    CTI BioPharma

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2001

First Posted

January 27, 2003

Study Start

March 1, 2001

Primary Completion

January 1, 2005

Study Completion

January 1, 2005

Last Updated

October 5, 2020

Record last verified: 2020-10

Locations

US(8)