Cholecalciferol in Improving Survival in Patients With Newly Diagnosed Cancer With Vitamin D Insufficiency

Chronic Lymphocytic Leukemia Clinical Trial

Official title: Effect of Vitamin D Replacement on Tumor Response and Survival Parameters for Vitamin D Insufficient Patients With Cancer

Status Recruiting

Clinical Trial Summary

This partially randomized clinical trial studies cholecalciferol in improving survival in patients with newly diagnosed cancer with vitamin D insufficiency. Vitamin D replacement may improve tumor response and survival and delay time to treatment in patients with cancer who are vitamin D insufficient.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To determine if vitamin D replacement in vitamin D insufficient patients with newly diagnosed untreated diffuse large B-cell lymphoma (DLBCL) can improve event free survival at 12 months to be equivalent to that of a control population of vitamin D sufficient patients. (Study I) II. To assess the percentage of patients requiring treatment with conventional therapy at 36 in months in vitamin D insufficient patients with early stage chronic lymphocytic leukemia (CLL) being managed with observation who undergo vitamin D replacement. (Study II)

SECONDARY OBJECTIVES:

I. To assess the effect of vitamin D replacement in vitamin D insufficient patients with newly diagnosed untreated DLBCL on overall survival. (Study I) II. To assess the effect of vitamin D replacement in vitamin D insufficient patients with newly diagnosed untreated DLBCL on event free survival. (Study I) III. To assess the effect of vitamin D replacement in vitamin D insufficient patients with newly diagnosed untreated T cell lymphoma on event free and overall survival. (Study I) IV. To assess the effect of vitamin D replacement in vitamin D insufficient CLL patients on Bio-r response rate and overall response rate. (Study II) V. To assess time to treatment and overall survival in vitamin D insufficient CLL patients who received vitamin D replacement. (Study II)

TERTIARY OBJECTIVES:

I. To study immune effector cells (lymphocytes, monocytes), serum cytokines, and tumor cells from vitamin D deficient and sufficient patients to learn the effects of vitamin D on both tumor cells and the patient's immune system. (Study I-II)

OUTLINE:

Vitamin D sufficient patients receive no intervention. Vitamin D insufficient patients receive cholecalciferol orally (PO) once weekly for 12 weeks and then once monthly for a total of 36 months.

After completion of study treatment, patients are followed up for 2 years. ;

Related Conditions & MeSH terms

• Aggressive Non-Hodgkin Lymphoma
• Anaplastic Large Cell Lymphoma
• Angioimmunoblastic T-Cell Lymphoma
• Chronic Lymphocytic Leukemia
• Diffuse Large B-Cell Lymphoma
• Enteropathy-Associated T-Cell Lymphoma
• Hepatosplenic T-Cell Lymphoma
• Leukemia, Lymphocytic, Chronic, B-Cell
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Extranodal NK-T-Cell
• Lymphoma, Large B-Cell, Diffuse
• Lymphoma, Large-Cell, Anaplastic
• Lymphoma, Non-Hodgkin
• Lymphoma, Primary Cutaneous Anaplastic Large Cell
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Peripheral
• Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma
• Mediastinal (Thymic) Large B-Cell Lymphoma
• Nasal Type Extranodal NK/T-Cell Lymphoma
• Panniculitis
• Peripheral T-Cell Lymphoma, Not Otherwise Specified
• Primary Cutaneous Anaplastic Large Cell Lymphoma
• Refractory Anaplastic Large Cell Lymphoma
• Small Lymphocytic Lymphoma
• Subcutaneous Panniculitis-Like T-Cell Lymphoma

• NCT number: NCT01787409
• Study type: Interventional
• Source: Mayo Clinic
• Status: Recruiting
• Phase: N/A
• Start date: March 6, 2013
• Completion date: March 28, 2025