Arsenic Trioxide in Treating Patients With Myelodysplastic Syndromes

Sponsor

CTI BioPharma (Industry)

Overall Status

Terminated

CT.gov ID

NCT00020969

Collaborator

National Cancer Institute (NCI) (NIH)

Locations

46.1

Actual Duration (Months)

Study Details

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

Primary Purpose:

Treatment

Official Title:

Phase Two Multicenter Study Of Arsenic Trioxide In Patients With Myelodysplastic Syndromes

Actual Study Start Date :

Mar 1, 2001

Actual Primary Completion Date :

Jan 1, 2005

Actual Study Completion Date :

Jan 1, 2005

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Arizona Cancer Center at University of Arizona Health Sciences Center	Tucson	Arizona	United States	85724
2	Green Cancer Center at Scripps Clinic	La Jolla	California	United States	92037-1027
3	USC/Norris Comprehensive Cancer Center and Hospital	Los Angeles	California	United States	90033-0804
4	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California	United States	90095-1678
5	St. Joseph Hospital Regional Cancer Center - Orange	Orange	California	United States	92868-3849
6	Lynn Regional Cancer Center West	Boca Raton	Florida	United States	33428
7	Georgia Cancer Specialists - Northside Office	Atlanta	Georgia	United States	30342
8	Corpus Christi Cancer Center	Corpus Christi	Texas	United States	78412