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Phase II Study of Doxercalciferol for the Treatment of Myelodysplastic Syndromes


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

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Trial Information

Phase II Study of Doxercalciferol for the Treatment of Myelodysplastic Syndromes


OBJECTIVES:

- Determine the response rate of patients with myelodysplastic syndromes or chronic
myelomonocytic leukemia treated with doxercalciferol.

- Determine the toxicity profile of this drug in these patients.

- Determine the time to progression and overall survival of patients treated with this
drug.

OUTLINE: Patients receive oral doxercalciferol daily for 12 weeks. Treatment continues in
the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: Approximately 41 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Morphologically and cytogenetically confirmed myelodysplastic syndromes or chronic
myelomonocytic leukemia

- No more than 20% blasts by bone marrow biopsy

- Must meet at least 1 of the following criteria:

- Anemia

- Hemoglobin less than 11 g/dL over a 2-month period

- Thrombocytopenia

- Neutropenia

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- Not specified

Hematopoietic

- See Disease Characteristics

Hepatic

- ALT and AST less than 1.5 times upper limit of normal

- Bilirubin less than 3 mg/dL

- Albumin greater than 3.0 g/dL

Renal

- Creatinine clearance greater than 50 mL/min

- No history of hypercalcemia

- No renal stones within the past 5 years

Cardiovascular

- No clinically significant heart failure

- No uncontrolled hypertension

Pulmonary

- No clinically significant pulmonary failure

Other

- Not pregnant

- Fertile patients must use effective contraception during and for 6 months after study

PRIOR CONCURRENT THERAPY:

Biologic therapy

- At least 4 weeks since prior growth factor or cytokine therapy

Chemotherapy

- At least 8 weeks since prior cytotoxic chemotherapy

Endocrine therapy

- Not specified

Radiotherapy

- Not specified

Surgery

- Not specified

Other

- Concurrent transfusion support allowed

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Mark B. Juckett, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Wisconsin, Madison

Authority:

United States: Federal Government

Study ID:

CDR0000258754

NCT ID:

NCT00052832

Start Date:

September 2002

Completion Date:

Related Keywords:

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

Name

Location

University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792