Paricalcitol in Treating Patients With Myelodysplastic Syndrome

NCT00064376 | Completed Phase 2 FDA Drug

• 2 other identifiers: CDR0000315451CSMC-IRB-4107-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

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

Interventions

paricalcitol DRUG

Eligibility Criteria

• Age: 25 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead
• Abbott: collaborator

Study Sites (1)

Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Leukemia; Myelodysplastic Syndromes; Anemia, Refractory, with Excess of Blasts; Anemia, Refractory; Leukemia, Myelomonocytic, Chronic

Interventions

paricalcitol

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases; Anemia; Leukemia, Myeloid; Myelodysplastic-Myeloproliferative Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• H. Phillip Koeffler, MD

  Cedars-Sinai Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Medicine / Hematology/Oncology

Study Record Dates

• First Submitted: July 8, 2003
• First Posted: July 9, 2003
• Study Start: May 1, 2003
• Primary Completion: November 1, 2005
• Study Completion: November 1, 2005
• Last Updated: January 29, 2018

Record last verified: 2018-01

Locations

US (1)