Cholecalciferol in Treating Patients With Myelodysplastic Syndrome

NCT00068276 | Completed Phase 2 FDA Drug

• 3 other identifiers: CCCWFU-29203CDR0000318802CCCWFU-BG03-117
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Cholecalciferol (vitamin D) may improve quality of life by increasing blood counts, decreasing fatigue, and improving other symptoms of myelodysplastic syndrome. PURPOSE: This phase II trial is studying how well cholecalciferol works in treating patients with myelodysplastic syndrome.

Conditions

Leukemia; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Neoplasms

Keywords

previously treated myelodysplastic syndromes; de novo myelodysplastic syndromes; secondary myelodysplastic syndromes; atypical chronic myeloid leukemia, BCR-ABL1 negative; myelodysplastic/myeloproliferative neoplasm, unclassifiable; childhood myelodysplastic syndromes

Interventions

cholecalciferol DIETARY_SUPPLEMENT

Eligibility Criteria

• Age: Up to 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed myelodysplastic syndromes (MDS) * Must have undergone bone marrow aspirate and biopsy with karyotype within the past 3 months * International Prognostic Scoring System score of 0 or 1 PATIENT CHARACTERISTICS: Age * Any age Performance status * Any Life expectancy * More than 1 year Hematopoietic * Not specified Hepatic * Not specified Renal * No history of hypercalcemia PRIOR CONCURRENT THERAPY: Biologic therapy * Prior stem cell transplantation allowed * No concurrent hematopoietic growth factors Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified Other * More than 6 weeks since prior cholecalciferol supplements or analogs * More than 4 weeks since any prior therapy for MDS (except supportive care) * No other concurrent therapy for MDS

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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, 27157-1082, United States

Location

MeSH Terms

Conditions

Leukemia; Myelodysplastic Syndromes; Myelodysplastic-Myeloproliferative Diseases; Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative; Myeloproliferative Disorders

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Istvan Molnar, MD

  Wake Forest University Health Sciences

  STUDY CHAIR

• Bayard L. Powell, MD

  Wake Forest University Health Sciences

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2003
• First Posted: September 11, 2003
• Study Start: July 1, 2003
• Primary Completion: June 1, 2005
• Study Completion: September 1, 2006
• Last Updated: August 10, 2018

Record last verified: 2018-08

Locations

US (1)