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

Trial Status: Active

This 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.

Inclusion Criteria

  • PRE-REGISTRATION
  • Provide informed written consent
  • Submission of sample to central lab for Vitamin D assay; this review is mandatory prior to registration to confirm vitamin level; it should be initiated as soon after pre-registration as possible; Note: for Mayo sites this will be ordered through the clinical lab and for all other sites a portion of the research sample will be used
  • REGISTRATION
  • 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 (low grade and large cell; marginal and large cell; nodular lymphocyte predominant [LP] Hodgkin and large cell, etc) at the time of original diagnosis can also be enrolled as long as they have large cell component and will be treated with an anthracycline * Patients with high-grade B-cell lymphoma with rearrangements of MYC and BCL2 and/or BCL6 (formerly DLBCL with double or triple hit), high-grade B-cell lymphoma, not otherwise specified (NOS), B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma, and post-transplant DLBCL are also eligible as long as they meet other criteria and are receiving RCHOP-based therapy ** 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 any 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, obtained =< 42 days prior to registration; 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)

Arizona

Scottsdale
Mayo Clinic in Arizona
Status: CLOSED_TO_ACCRUAL
Contact: Craig B. Reeder
Phone: 480-301-8000

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: ACTIVE
Contact: Jean L Koff

Iowa

Iowa City
University of Iowa / Holden Comprehensive Cancer Center
Status: ACTIVE
Contact: Brian K. Link
Phone: 800-237-1225

Minnesota

Rochester
Mayo Clinic in Rochester
Status: ACTIVE
Contact: Thomas E. Witzig
Phone: 507-284-2511

Missouri

Saint Louis
Washington University School of Medicine
Status: CLOSED_TO_ACCRUAL
Contact: Kenneth Robert Carson
Phone: 314-747-7402

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)

CORRELATIVE RESEARCH 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.

Trial Phase Phase NA

Trial Type Treatment

Lead Organization
Mayo Clinic in Rochester

Principal Investigator
Thomas E. Witzig

  • Primary ID LS1293
  • Secondary IDs NCI-2013-00037
  • Clinicaltrials.gov ID NCT01787409