NCT00104806

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_2 leukemia

Timeline
Completed

Started Nov 2004

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 4, 2005

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

August 10, 2018

Status Verified

August 1, 2018

Enrollment Period

1.2 years

First QC Date

March 3, 2005

Last Update Submit

August 8, 2018

Conditions

LeukemiaMyelodysplastic SyndromesMyelodysplastic/Myeloproliferative Neoplasms

Keywords

de novo myelodysplastic syndromesmyelodysplastic/myeloproliferative neoplasm, unclassifiablepreviously treated myelodysplastic syndromessecondary myelodysplastic syndromesrefractory anemia with excess blasts in transformationrefractory anemia with excess blastsrefractory anemiarefractory anemia with ringed sideroblastsrefractory cytopenia with multilineage dysplasiachronic myelomonocytic leukemiachildhood myelodysplastic syndromes

Outcome Measures

Primary Outcomes (2)

  • Complete response rate

    6 months

  • toxicity assessment after therapy

    28 days

Interventions

cholecalciferolDIETARY_SUPPLEMENT

100 milligrams orally once a day for 28 days

arsenic trioxideDRUG

0.3 milligram/kilogram weight intravenously for 5 days (loading) then 0.25/kg weight intravenously biweekly

Eligibility Criteria

AgeUp to 120 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096, United States

Location

MeSH Terms

Conditions

LeukemiaMyelodysplastic SyndromesMyelodysplastic-Myeloproliferative DiseasesMyeloproliferative DisordersAnemia, Refractory, with Excess of BlastsAnemia, RefractoryLeukemia, Myelomonocytic, Chronic

Interventions

CholecalciferolArsenic Trioxide

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesBone Marrow DiseasesAnemiaLeukemia, MyeloidChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipidsArsenicalsInorganic ChemicalsOxidesOxygen Compounds

Study Officials

  • Istvan Molnar, MD

    Wake Forest University Health Sciences

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2005

First Posted

March 4, 2005

Study Start

November 1, 2004

Primary Completion

January 1, 2006

Study Completion

May 1, 2010

Last Updated

August 10, 2018

Record last verified: 2018-08

Locations

US(1)