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Arsenic Trioxide and Cholecalciferol (Vitamin D) in Treating Patients With Myelodysplastic Syndromes
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Wake Forest University
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00104806
  Purpose

RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Cholecalciferol (vitamin D) may help cancer cells become normal cells. Giving arsenic trioxide together with cholecalciferol (vitamin D) may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving arsenic trioxide together with cholecalciferol (vitamin D) works in treating patients with myelodysplastic syndromes.


Condition Intervention Phase
Leukemia
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Diseases
 Drug: arsenic trioxide
Drug: cholecalciferol
 Phase II

MedlinePlus related topics: Anemia Arsenic Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood
Drug Information available for: Arsenic trioxide Vitamin D Ergocalciferol Cholecalciferol
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Phase II Trial of Arsenic Trioxide and Dose-Escalated Cholecalciferol in Myelodysplastic Syndrome

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Complete response rate [ Designated as safety issue: No ]
  • Rate of hematological improvement [ Designated as safety issue: No ]
  • Time to progression [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall and progression-free survival [ Designated as safety issue: No ]
  • Change in bone marrow apoptosis and expression of p21 protein [ Designated as safety issue: No ]

Study Start Date: November 2004
Detailed Description:

OBJECTIVES:

Primary

  • Determine the complete response rate and the rate of hematological improvement in patients with myelodysplastic syndromes treated with arsenic trioxide and cholecalciferol (vitamin D).

Secondary

  • Determine the safety of this regimen in these patients.
  • Determine the time to progression to acute myeloid leukemia, defined as blast ≥ 20%, in patients treated with this regimen.
  • Determine overall survival and progression-free survival of patients treated with this regimen.
  • Determine the effect of this regimen on bone marrow and peripheral blood mononuclear cell apoptosis and p21 protein expression in these patients.

OUTLINE: This is an open-label, nonrandomized study.

Patients receive oral cholecalciferol (vitamin D)* once daily on days 1-28. Patients also receive arsenic trioxide IV over 1-4 hours on days 1-5 (week 1) and then twice weekly for 3 weeks (weeks 2-4) for course 1 and twice weekly for 4 weeks for all subsequent courses. Courses repeat every 28 days for up to 12 months in the absence of disease progression or unacceptable toxicity.

NOTE: * Patients who do not achieve a complete hematologic response receive escalating doses of cholecalciferol (vitamin D) at 3, 6, and 9 months during therapy in the absence of disease progression and unacceptable toxicity.

At the completion of study treatment, patients are followed for survival.

PROJECTED ACCRUAL: A total of 25-60 patients will be accrued for this study.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of myelodysplastic syndromes (MDS)

    • Bone marrow aspirate and biopsy with karyotyping performed within the past 12 weeks

PATIENT CHARACTERISTICS:

Age

  • Any age

Performance status

  • ECOG 0-2

Life expectancy

  • More than 6 months

Hematopoietic

  • Ferritin ≥ 50 ng/mL
  • Folate (serum and/or red blood cell) normal

Hepatic

  • Not specified

Renal

  • Creatinine < 2.0 mg/dL
  • No history of hypercalcemia

Cardiovascular

  • Absolute QT interval ≤ 460 msec by EKG with normal potassium and magnesium levels

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 2 weeks after study participation
  • Serum vitamin B_12 normal

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Prior biologic therapy allowed
  • More than 28 days since prior hematopoietic growth factors (e.g., filgrastim [G-CSF], sargramostim [GM-CSF], or epoetin alfa) for MDS
  • No concurrent hematopoietic growth factors (e.g., G-CSF, GM-CSF, or epoetin alfa)
  • No concurrent interleukin-11

Chemotherapy

  • Prior chemotherapy allowed

Endocrine therapy

  • Not specified

Radiotherapy

  • Prior radiotherapy allowed

Surgery

  • Not specified

Other

  • More than 28 days since prior therapy for MDS except supportive therapy
  • No concurrent cholecalciferol (vitamin D) analog, including topical therapy
  • No concurrent vitamins or supplements containing cholecalciferol (vitamin D)
  • No other concurrent therapy for MDS
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00104806

Locations
United States, North Carolina
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
Sponsors and Collaborators
Wake Forest University
National Cancer Institute (NCI)
Investigators
Study Chair: Istvan Molnar, MD Wake Forest University
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000415574, CCCWFU-29304, CCCWFU-BG04-452
Study First Received: March 3, 2005
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00104806  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
de novo myelodysplastic syndromes
previously treated myelodysplastic syndromes
secondary myelodysplastic syndromes
childhood myelodysplastic syndromes
myelodysplastic/myeloproliferative disease, unclassifiable
refractory anemia with excess blasts in transformation
 refractory anemia with excess blasts
refractory anemia
refractory anemia with ringed sideroblasts
refractory cytopenia with multilineage dysplasia
chronic myelomonocytic leukemia

Study placed in the following topic categories:
Myelodysplastic syndromes
Cholecalciferol
Precancerous Conditions
Chronic myelomonocytic leukemia
Refractory anemia
Hematologic Diseases
Leukemia, Myelomonocytic, Chronic
Myelodysplasia
Myelodysplastic Syndromes
Ergocalciferols
Myeloproliferative Disorders
 Anemia
Arsenic trioxide
Myelodysplastic myeloproliferative disease
Leukemia
Preleukemia
Vitamin D
Anemia, Refractory
Neoplasm Metastasis
Anemia, Refractory, with Excess of Blasts
Myelodysplastic-Myeloproliferative Diseases
Bone Marrow Diseases

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Disease
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Pharmacologic Actions
 Neoplasms
Pathologic Processes
Syndrome
Vitamins
Therapeutic Uses
Micronutrients

ClinicalTrials.gov processed this record on January 16, 2009



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