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

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) III. To determine the incidence of vitamin D insufficiency in Alaska Native People with untreated breast cancer and colorectal cancer. (Study III)

     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) V. To assess the effect of vitamin D replacement in vitamin D insufficient Alaskan Native patients with newly diagnosed colorectal cancer (CRC) or breast cancer (BC) on event free and overall survival. (Study III)

     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) II. To assess the kinetics of vitamin D replacement in vitamin D insufficient Alaskan Native people with CRC or BC. (Study III)

     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.

     STUDY III: 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.

Who is eligible to participate?

Inclusion Criteria:

         -  Newly diagnosed aggressive lymphoma, CLL/small lymphocytic lymphoma (SLL), colorectal cancer, or breast cancer 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); 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 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 consisting of small to moderate size lymphocytes, with < 55% prolymphocytes

                        -  Immunophenotyping consistent with CLL defined as:

                             -  The predominant population of lymphocytes share both B-cell antigens (CD19, 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 FISH analysis for t(11;14)(IgH/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

         -  Study 3 - Alaskan Native Medical Center patients with colorectal cancer or breast cancer

              -  New cancer of the colon, rectum, or breast

              -  =< 12 weeks from the initial biopsy

         -  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

         -  Provide informed written consent

         -  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

       Exclusion Criteria:

         -  STUDY 2: Unwilling to be randomized to placebo for one year

Last updated:
4/2/2013
NCT ID:
NCT01787409
IRB Number:
12-007862