Clinical trial NCT00064376: Paricalcitol in Treating Patients With Myelodysplastic Syndrome
Official title: A Phase II Trial Of Paricalcitol In Myelodysplastic Syndromes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Leukemia
Myelodysplastic Syndromes
Keywords: de novo myelodysplastic syndromes
previously treated myelodysplastic syndromes
secondary myelodysplastic syndromes
refractory anemia with excess blasts in transformation
refractory anemia with excess blasts
refractory anemia with ringed sideroblasts
refractory anemia
chronic myelomonocytic leukemia
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2003-07-09
Sex: ALL
Minimum age (years): 25
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: RATIONALE: Paricalcitol is a form of vitamin D that may help myelodysplastic cells develop into normal bone marrow cells.

PURPOSE: Phase II trial to study the effectiveness of paricalcitol in treating patients who have myelodysplastic syndrome.

Detailed description: OBJECTIVES:

* Determine the clinical effects of paricalcitol in patients with myelodysplastic syndromes.
* Determine whether this drug can improve RBC, WBC, or platelet counts in these patients.
* Determine whether this drug can decrease the risk of development of leukemia without causing undue toxicity in these patients.

OUTLINE: Patients receive oral paricalcitol daily for 4 months in the absence of disease progression or unacceptable toxicity.

Patients are followed at 1 month.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study within 8 months.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Clinical diagnosis of myelodysplastic syndromes according to the modified FAB classification

  * Confirmed by bone marrow aspiration showing blast and promyelocyte count no greater than 30% of the bone marrow differential
* Patients with refractory anemia with ringed sideroblasts are eligible provided there was no response to a 3-week course of prior high-dose pyridoxine

PATIENT CHARACTERISTICS:

Age

* 25 to 100

Performance status

* Karnofsky 60-100%

Life expectancy

* At least 12 weeks

Hematopoietic

* See Disease Characteristics

Hepatic

* Bilirubin less than 2.0 mg/dL

Renal

* Creatinine less than 2.5 mg/dL
* Calcium normal

Other

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No prior sensitivity to paricalcitol or any component of its formulation
* No prior cholecalciferol toxicity
* No other concurrent acute illness

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* More than 5 weeks since prior chemotherapy

Endocrine therapy

* Not specified

Radiotherapy

* More than 5 weeks since prior radiotherapy

Surgery

* Prior recent surgery allowed, if fully recovered

Other

* More than 5 weeks since prior megadose vitamins
* No concurrent cholecalciferol, phosphate, calcium, or cholestyramine
* No concurrent digoxin

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: H. Phillip Koeffler, MD
role: STUDY_CHAIR
References: