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


N/A
18 Years
N/A
Open (Enrolling)
Both
Adult Nasal Type Extranodal NK/T-cell Lymphoma, Anaplastic Large Cell Lymphoma, Angioimmunoblastic T-cell Lymphoma, Contiguous Stage II Adult Diffuse Large Cell Lymphoma, Hepatosplenic T-cell Lymphoma, Male Breast Cancer, Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma, Peripheral T-cell Lymphoma, Stage 0 Chronic Lymphocytic Leukemia, Stage I Adult Diffuse Large Cell Lymphoma, Stage I Chronic Lymphocytic Leukemia, Stage I Colon Cancer, Stage I Cutaneous T-cell Non-Hodgkin Lymphoma, Stage I Rectal Cancer, Stage I Small Lymphocytic Lymphoma, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage II Breast Cancer, Stage II Cutaneous T-cell Non-Hodgkin Lymphoma, Stage IIA Colon Cancer, Stage IIA Rectal Cancer, Stage IIB Colon Cancer, Stage IIB Rectal Cancer, Stage IIC Colon Cancer, Stage IIC Rectal Cancer, Stage III Adult Diffuse Large Cell Lymphoma, Stage III Cutaneous T-cell Non-Hodgkin Lymphoma, Stage IIIA Breast Cancer, Stage IIIA Colon Cancer, Stage IIIA Rectal Cancer, Stage IIIB Breast Cancer, Stage IIIB Colon Cancer, Stage IIIB Rectal Cancer, Stage IIIC Breast Cancer, Stage IIIC Colon Cancer, Stage IIIC Rectal Cancer, Stage IV Adult Diffuse Large Cell Lymphoma, Stage IV Breast Cancer, Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma, Stage IVA Colon Cancer, Stage IVA Rectal Cancer, Stage IVB Colon Cancer, Stage IVB Rectal Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Vitamin D replacement in vitamin D insufficient patients with newly diagnosed untreated DLBCL can improve event free survival (Study I) at 12 months calculated by the exact binomial method.

Outcome Description:

The proportion of successes will be estimated separately in the groups by the number of successes divided by the total number of evaluable patients. 95% confidence intervals for the true success proportion will be calculated by the exact binomial method.

Outcome Time Frame:

Time from study registration to lymphoma progression, initiation of new anti-lymphoma therapy after completion or cessation of the original anthracycline based treatment, or death due to any cause, assessed at 12 months

Safety Issue:

No

Principal Investigator

Thomas Witzig

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Food and Drug Administration

Study ID:

LS1293

NCT ID:

NCT01787409

Start Date:

March 2013

Completion Date:

Related Keywords:

  • Adult Nasal Type Extranodal NK/T-cell Lymphoma
  • Anaplastic Large Cell Lymphoma
  • Angioimmunoblastic T-cell Lymphoma
  • Contiguous Stage II Adult Diffuse Large Cell Lymphoma
  • Hepatosplenic T-cell Lymphoma
  • Male Breast Cancer
  • Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma
  • Peripheral T-cell Lymphoma
  • Stage 0 Chronic Lymphocytic Leukemia
  • Stage I Adult Diffuse Large Cell Lymphoma
  • Stage I Chronic Lymphocytic Leukemia
  • Stage I Colon Cancer
  • Stage I Cutaneous T-cell Non-Hodgkin Lymphoma
  • Stage I Rectal Cancer
  • Stage I Small Lymphocytic Lymphoma
  • Stage IA Breast Cancer
  • Stage IB Breast Cancer
  • Stage II Breast Cancer
  • Stage II Cutaneous T-cell Non-Hodgkin Lymphoma
  • Stage IIA Colon Cancer
  • Stage IIA Rectal Cancer
  • Stage IIB Colon Cancer
  • Stage IIB Rectal Cancer
  • Stage IIC Colon Cancer
  • Stage IIC Rectal Cancer
  • Stage III Adult Diffuse Large Cell Lymphoma
  • Stage III Cutaneous T-cell Non-Hodgkin Lymphoma
  • Stage IIIA Breast Cancer
  • Stage IIIA Colon Cancer
  • Stage IIIA Rectal Cancer
  • Stage IIIB Breast Cancer
  • Stage IIIB Colon Cancer
  • Stage IIIB Rectal Cancer
  • Stage IIIC Breast Cancer
  • Stage IIIC Colon Cancer
  • Stage IIIC Rectal Cancer
  • Stage IV Adult Diffuse Large Cell Lymphoma
  • Stage IV Breast Cancer
  • Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma
  • Stage IVA Colon Cancer
  • Stage IVA Rectal Cancer
  • Stage IVB Colon Cancer
  • Stage IVB Rectal Cancer
  • Breast Neoplasms
  • Colonic Neoplasms
  • Rectal Neoplasms
  • Immunoblastic Lymphadenopathy
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Non-Hodgkin
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Cutaneous
  • Lymphoma, T-Cell, Peripheral
  • Lymphoma, Large-Cell, Anaplastic
  • Breast Neoplasms, Male
  • Lymphoma, Extranodal NK-T-Cell

Name

Location

University of IowaIowa City, Iowa  52242
Mayo ClinicRochester, Minnesota  55905
University of Wisconsin Cancer Center RiverviewWisconsin Rapids, Wisconsin  54494