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

Location:

Rochester, Minn.

Trial status:

Open for Enrollment

Why is this study being done?

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 determine if vitamin D replacement in vitamin D insufficient patients with early stage chronic lymphocytic leukemia (CLL) being managed with observation can improve the percentage of patients requiring treatment with conventional therapy at 36 months to that of a control population of vitamin D sufficient patients. (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 if vitamin D replacement will increase the tumor response rate in Vitamin D insufficient CLL patients. (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: STUDY I: 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. STUDY II: Vitamin D sufficient patients receive no intervention. Vitamin D insufficient patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive cholecalciferol PO once weekly for 12 weeks and then once monthly for a total of 36 months. ARM II: Patients receive placebo PO once weekly for 12 weeks and then once monthly for a total of 12 months. Patients then receive cholecalciferol once monthly for up to 24 months. After completion of study treatment, patients are followed up for 2 years.

Who is eligible to participate?

Inclusion Criteria: - Newly diagnosed aggressive lymphoma or CLL/small lymphocytic lymphoma (SLL) that meets disease specific criteria below: - Study 1 - Aggressive lymphoma - Newly diagnosed de-novo DLBCL or primary mediastinal B-cell lymphoma that will be treated with an anthracycline-containing regimen (rituximab-cyclophosphamide, doxorubicin hydrochloride, prednisone [R-CHOP] or equivalent); patients with composite lymphomas can also be enrolled as long as they have large cell component and will be treated with an anthracycline; in addition, patients with "B cell lymphoma, unclassifiable, with features intermediate between diffuse large B cell lymphoma and Burkitt lymphoma" or post-transplant DLBCL are also eligible as long as they meet other criteria; patients with typical Burkitt lymphoma are not eligible - NOTE: patients can be enrolled up through day 1 of cycle 3 of therapy; the patient is permitted to participate in any other therapeutic therapy for their disease as long as it does not concern vitamin D; patients can begin their chemotherapy while awaiting vitamin D results and treatment arm assignment or - Newly diagnosed untreated peripheral T-cell non-Hodgkin lymphoma (NHL) that will be treated with chemotherapy; NOTE: patients can be enrolled up through day 1 of cycle 3 of therapy; this includes the following disease types: - Peripheral T cell lymphoma, unspecified - Anaplastic large cell lymphoma (T and null cell type) - Extranodal NK/T-cell lymphoma, nasal type - Enteropathy-type T-cell lymphoma - Hepatosplenic T-cell lymphoma - Subcutaneous panniculitis-like T-cell lymphoma - Angioimmunoblastic T-cell lymphoma - Anaplastic large cell lymphoma - primary cutaneous type and - Willing to provide tissue for correlative research purposes - Study 2 - CLL/SLL - Newly diagnosed (< 12 months from pre-registration on this study) CLL according to the National Cancer Institute (NCI) criteria or SLL according to the World Health Organization (WHO) criteria; this includes previous documentation of: - Biopsy-proven small lymphocytic lymphoma - Diagnosis of CLL according to NCI working group criteria as evidenced by all of the following: - Peripheral blood lymphocyte count of > 5,000/mm^3; if present, prolymphocytes should be < 55% - Immunophenotyping consistent with CLL defined as: - The predominant population of lymphocytes share both B-cell antigens (cluster of differentiation [CD]19, CD20, or CD23) as well as CD5 in the absence of other pan-T-cell markers (CD3, CD2, etc.) - Dim surface immunoglobulin expression - Restricted surface kappa or lambda light chain expression - Before diagnosing CLL or SLL, mantle cell lymphoma must be excluded by demonstrating a negative fluorescent in situ hybridization (FISH) analysis for t(11;14)(immunoglobulin H [IgH]/cyclin D 1 [CCND1]) on peripheral blood or tissue biopsy or negative immunohistochemical stains for cyclin D1 on involved tissue biopsy - Rai stage 0 or 1 - Previously untreated - Asymptomatic with the plan for observation - Life expectancy of at least 24 months - Willing to provide tissue for correlative research purposes - Willing to be randomized to placebo for one year - Both Studies: - Capable of swallowing intact study medication capsules - Serum calcium < 11 mg/dL; note: patients with hypercalcemia can be enrolled after the calcium is corrected with standard of care treatments - Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study) - Note: During the Active Monitoring Phase of a study (i.e., active treatment and observation), participants must be willing to return to the consenting institution for follow-up - Willing to provide blood samples for correlative research purposes - Vitamin D level (25 hydroxy D2 + hydroxyl D3) confirmed by central laboratory review

Last updated:

7/22/2014

NCT ID:

NCT01787409

IRB Number:

12-007862