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Therapy of Advanced Stage Myelodysplastic Syndrome (MDS) With Arsenic Trioxide Given in Combination With Etanercept: A Phase I/II Study


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Diseases

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Trial Information

Therapy of Advanced Stage Myelodysplastic Syndrome (MDS) With Arsenic Trioxide Given in Combination With Etanercept: A Phase I/II Study


OBJECTIVES:

- Determine the frequency of hematologic response in patients with intermediate-2 or
high-risk myelodysplastic syndromes (MDS) treated with arsenic trioxide and etanercept.

- Determine the efficacy of this regimen in patients with intermediate-1 or low-risk MDS
that was refractory to anti-thymocyte globulin and etanercept on protocol FHCRC-1872.

- Correlate results of ex vivo and in vitro studies of phenotypic, cytogenetic, and
functional disease characteristics with in vivo treatment response in patients treated
with this regimen.

- Determine parameters that are associated with a high probability of disease response in
patients treated with this regimen.

OUTLINE: This is a pilot study.

Patients receive arsenic trioxide IV over 1-4 hours on days 1-5 of week 1 and then twice
weekly on weeks 2-12 during course 1 (twice weekly on weeks 1-12 during course 2). Patients
also receive etanercept subcutaneously twice weekly during weeks 1, 2, 5, 6, 9, and 10.
Treatment repeats every 12 weeks for 2 courses in the absence of disease progression or
unacceptable toxicity.

Patients are followed for 3 months.

PROJECTED ACCRUAL: A total of 15-32 patients will be accrued for this study within 8-18
months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of myelodysplastic syndromes (MDS) meeting 1 of the following criteria:

- Intermediate-2 or high-risk disease

- Intermediate-1 or low-risk disease that was refractory to anti-thymocyte
globulin and etanercept on protocol FHCRC-1872

- Not eligible for stem cell transplantation for any of the following reasons:

- Suitable bone marrow donor is not available

- Ineligible for a transplantation protocol

- Not willing to undergo transplantation

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- Not specified

Hematopoietic

- Absolute neutrophil count > 500/mm^3

Hepatic

- Not specified

Renal

- Not specified

Cardiovascular

- No evidence of cardiac arrhythmia

- No evidence of congestive heart failure

- QTc interval ≤ 460 msec

Pulmonary

- No pneumonia

Other

- Potassium > 4.0 mEq/L (supplemental electrolytes allowed)

- Magnesium > 1.8 mg/dL (supplemental electrolytes allowed)

- No history of anaphylactic reaction to arsenic trioxide

- No active severe infection (e.g., septicemia) within the past 2 weeks

- No other severe disease that would preclude study compliance

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

- See Disease Characteristics

- No prior hematopoietic stem cell transplantation

- More than 4 weeks since prior hematopoietic growth factors for MDS

- More than 4 weeks since prior immunomodulatory therapy for MDS

- No concurrent hematopoietic growth factors for MDS

- No other concurrent immunomodulatory therapy for MDS

Chemotherapy

- Not specified

Endocrine therapy

- Not specified

Radiotherapy

- Not specified

Surgery

- Not specified

Other

- More than 4 weeks since prior cytotoxic therapy for MDS

- More than 4 weeks since prior experimental therapy for MDS

- No other concurrent cytotoxic therapy for MDS

- No other concurrent experimental therapy for MDS

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

Hematologic response in patients with intermediate-2 or high-risk myelodysplastic syndromes

Safety Issue:

No

Principal Investigator

Bart L. Scott, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fred Hutchinson Cancer Research Center

Authority:

United States: Federal Government

Study ID:

1888.00

NCT ID:

NCT00093366

Start Date:

June 2004

Completion Date:

July 2006

Related Keywords:

  • Leukemia
  • Myelodysplastic Syndromes
  • Myelodysplastic/Myeloproliferative Diseases
  • de novo myelodysplastic syndromes
  • previously treated myelodysplastic syndromes
  • secondary myelodysplastic syndromes
  • myelodysplastic/myeloproliferative disease, unclassifiable
  • atypical chronic myeloid leukemia
  • chronic myelomonocytic leukemia
  • Leukemia
  • Myelodysplastic Syndromes
  • Preleukemia
  • Myeloproliferative Disorders
  • Myelodysplastic-Myeloproliferative Diseases

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109