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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Scott C. Stromatt, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Cell Therapeutics

Authority:

United States: Federal Government

Study ID:

CDR0000068734

NCT ID:

NCT00020969

Start Date:

March 2001

Completion Date:

Related Keywords:

  • Leukemia
  • Myelodysplastic Syndromes
  • Myelodysplastic/Myeloproliferative Neoplasms
  • 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
  • Neoplasms
  • Leukemia
  • Myelodysplastic Syndromes
  • Preleukemia
  • Myeloproliferative Disorders
  • Myelodysplastic-Myeloproliferative Diseases

Name

Location
Jonsson Comprehensive Cancer Center, UCLA Los Angeles, California  90095-1781
USC/Norris Comprehensive Cancer Center and Hospital Los Angeles, California  90033-0804
Arizona Cancer Center at University of Arizona Health Sciences Center Tucson, Arizona  85724
Green Cancer Center at Scripps Clinic La Jolla, California  92037
St. Joseph Hospital Regional Cancer Center - Orange Orange, California  92868-3849
Lynn Regional Cancer Center West Boca Raton, Florida  33428
Georgia Cancer Specialists - Northside Office Atlanta, Georgia  30342
Corpus Christi Cancer Center Corpus Christi, Texas  78412