Cholecalciferol in Treating Patients With Acute Myeloid Leukemia Undergoing Intensive Induction Chemotherapy

Brief Title

Cholecalciferol in Treating Patients With Acute Myeloid Leukemia Undergoing Intensive Induction Chemotherapy

Official Title

Vitamin D3 Supplementation in Acute Myeloid Leukemia: Pharmacokinetic Study

Brief Summary

      This partially randomized phase II trial studies the side effects and best way to give and
      best dose of cholecalciferol in treating patients with acute myeloid leukemia (AML)
      undergoing intensive induction chemotherapy. Cholecalciferol may help improve the outcome of
      patients with AML undergoing intensive chemotherapy
    

Detailed Description

      PRIMARY OBJECTIVES: I. To assess patients with regards to changes in 25(OH)-D3 changes after
      supplementation. II. To develop a pharmacokinetic model to describe the time course of the
      relationship of vitamin D3 (cholecalciferol) supplementation that drives the levels of
      25(OH)-D3 during the intensive induction chemotherapy. III. To determine the safety and
      toxicity of vitamin D3 supplementation in AML patients undergoing intensive induction
      chemotherapy. SECONDARY OBJECTIVES: I. To explore whether rapid (loading dose of vitamin D3)
      normalization of 25(OH)-D3 levels will have an effect on the progression free and overall
      survival. II. To explore whether a relationship exists between the pharmacokinetics of the
      25-hydroxy-vitamin D3 and white blood cell count. OUTLINE: Patients with pretreatment
      25(OH)-D3 levels 20-31.9 ng/mL (insufficient levels) are randomized to 1 of 2 treatment arms.
      ARM I: Patients receive a loading dose of cholecalciferol orally (PO) on day 1. Patients then
      receive lower-dose cholecalciferol PO beginning on day 8. ARM II: Patients receive a loading
      dose of cholecalciferol PO on day 1. Patients then receive higher-dose cholecalciferol PO
      beginning on day 8. Patients with pretreatment 25(OH)-D3 levels < 20 ng/mL (deficient levels)
      receive a loading dose of cholecalciferol PO on days 1 and 8. Patients then receive
      lower-dose cholecalciferol PO beginning on day 15. For all patients, treatment continues in
      the absence of disease progression or unacceptable toxicity. After completion of study
      treatment, patients are followed up at 30 days.
    

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Changes in 25(OH)-D3 levels after supplementation

Condition

Adult Acute Megakaryoblastic Leukemia (M7)

Intervention

cholecalciferol

Study Arms / Comparison Groups

 Arm I (25(OH)-D3 levels 20-31.9 ng/mL [insufficient levels])

Description:  Patients receive a loading dose of cholecalciferol PO on day 1. Patients then receive lower-dose cholecalciferol PO beginning on day 8.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Dietary Supplement

Estimated Enrollment

4

Start Date

December 2011

Completion Date

June 2015

Primary Completion Date

March 2013

Eligibility Criteria

        Inclusion Criteria: Pathologic diagnosis of newly diagnosed AML (excluding acute
        promyelocytic leukemia [APL]) Patients undergoing intensive induction therapy (equivalent
        of 7+3, cytarabine, daunorubicin, etoposide [ADE] or high-dose cytarabine containing
        regimens) Subnormal 25(OH)-D3 levels (< 32 ng/mL) Serum calcium =< upper limit of normal
        Demonstrate the ability to swallow and retain oral medication Patients of child-bearing
        potential must agree to use acceptable contraceptive methods (e.g., double barrier) during
        treatment Patient or legal representative must understand the investigational nature of
        this study and sign an Independent Ethics Committee/Institutional Review Board approved
        written informed consent form prior to receiving any study related procedure Exclusion
        Criteria: Patients should not have a history of nephrocalcinosis Patients should not have
        received bisphosphonate treatment within 28 days before study entry Pregnant or nursing
        female patients Unwilling or unable to follow protocol requirements Any condition which in
        the Investigator's opinion deems the patient an unsuitable candidate to receive study drug
        Received an investigational agent within 30 days prior to enrollment Patients who cannot be
        discontinued from cimetidine, thiazide diuretics and/or heparin Patients who are on
        magnesium based antacids who cannot be offered an alternative regimen
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Meir Wetzler, , 

Location Countries

United States

Location Countries

United States

NCT ID

NCT01521936

Organization ID

I 201311

Secondary IDs

NCI-2011-03554

Responsible Party

Sponsor

Study Sponsor

Roswell Park Cancer Institute

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Meir Wetzler, Principal Investigator, Roswell Park Cancer Institute

Verification Date

June 2015