cholecalciferol in improving survival in patients with newly diagnosed cancer with vitamin d insufficiency

Conditions: 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; Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma; Mediastinal (Thymic) Large B-Cell Lymphoma; Nasal Type Extranodal NK/T-Cell Lymphoma; 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

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.

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.

Eligibility criteria:
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 * 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 exclusion criteria: * patients with burkitt lymphoma or any patient receiving rituximab-cyclophosphamide, vincristine, doxorubicin, high-dose methotrexate / ifosfamide, etoposide, high-dose cytarabine (r- codoxm/ivac) * patients who previously had indolent lymphoma and now at a separate episode have large cell nhl (i.e. transformation