Paricalcitol in Treating Patients With Myelodysplastic Syndrome

• Sponsor: Cedars-Sinai Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00064376
• Collaborator: Abbott (Industry)
• Location: 1
• Actual Duration (Months): 30.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Leukemia; Myelodysplastic Syndromes	Drug: paricalcitol	Phase 2

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.

Study Design

• Study Type: Interventional
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Trial Of Paricalcitol In Myelodysplastic Syndromes
• Actual Study Start Date: May 1, 2003
• Actual Primary Completion Date: Nov 1, 2005
• Actual Study Completion Date: Nov 1, 2005

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center	Los Angeles	California	United States	90048

Sponsors and Collaborators

• Cedars-Sinai Medical Center
• Abbott

Investigators

• Study Chair: H. Phillip Koeffler, MD, Cedars-Sinai Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: H. Phillip Koeffler, Director, Medicine / Hematology/Oncology, Cedars-Sinai Medical Center
• ClinicalTrials.gov Identifier: NCT00064376
• Other Study ID Numbers: CDR0000315451; CSMC-IRB-4107-01
• First Posted: Jul 9, 2003
• Last Update Posted: Jan 29, 2018
• Last Verified: Jan 1, 2018

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by H. Phillip Koeffler, Director, Medicine / Hematology/Oncology, Cedars-Sinai Medical Center: 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
• Additional relevant MeSH terms: Preleukemia; Myelodysplastic Syndromes; Syndrome

Study Results

No Results Posted as of Jan 29, 2018