Clinical trial NCT00052832: Doxercalciferol in Treating Patients With Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia
Official title: Phase II Study of Doxercalciferol for the Treatment of Myelodysplastic Syndromes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Leukemia
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Diseases
Keywords: chronic myelomonocytic leukemia
previously treated myelodysplastic syndromes
secondary myelodysplastic syndromes
de novo myelodysplastic syndromes
atypical chronic myeloid leukemia
myelodysplastic/myeloproliferative disease, unclassifiable
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: RATIONALE: Doxercalciferol may improve low blood cell counts and decrease the need for blood transfusions and may be an effective treatment for myelodysplastic syndrome or chronic myelomonocytic leukemia.

PURPOSE: Phase II trial to study the effectiveness of doxercalciferol in treating patients who have myelodysplastic syndrome or chronic myelomonocytic leukemia.

Detailed description: 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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Comprehensive Cancer Center
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Mark B. Juckett, MD
role: STUDY_CHAIR
References:
citation: Petrich A, Kahl B, Bailey H, Kim K, Turman N, Juckett M. Phase II study of doxercalciferol for the treatment of myelodysplastic syndrome. Leuk Lymphoma. 2008 Jan;49(1):57-61. doi: 10.1080/10428190701713648.