Myelodysplastic SyndromesPhase 2NCT00030069
Calcitriol and Dexamethasone in Patients With Myelodysplastic Syndromes
A Phase 2 study testing Calcitriol and Dexamethasone in people with Myelodysplastic Syndromes, run by University of Pittsburgh at 1 site in United States.
Trial summary
This is a study to determine the response rate in patients with myelodysplastic syndromes treated with calcitriol and dexamethasone. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Myelodysplastic Syndromes
- What is being tested?
- Calcitriol and Dexamethasone
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2001to May 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Histologically confirmed refractory anemia (RA), RA with excess blasts (RAEB), RAEB in transformation (RAEB-IT), or ringed sideroblasts (RARS)
- Evidence of cytopenia affecting at least 1 hematological cell lineage
- Adequate liver and renal function
- ECOG 0-2
- Expected survival of at least 12 weeks
Who cannot join
- Symptomatic coronary artery disease
- Uncontrolled diabetes mellitus
- Uncontrolled and symptomatic glaucoma
- History of dangerous reactions to steroid therapy
- Chemotherapy or any hematopoietic growth factor therapy within the past 8 weeks
- History of nephrolithiasis
- Children
- Chronic myelomonocytic leukemia (CMML)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Calcitriol and Dexamethasone for Myelodysplastic Syndromes
This is a study to determine the response rate in patients with myelodysplastic syndromes treated with calcitriol and dexamethasone.
Read the detailed description
Current therapeutic options for myelodysplastic syndromes (MDS) are limited and, aside from bone marrow transplantation, none have proven superior to supportive measures alone. Preclinical investigations have indicated the potential therapeutic role for vitamin D in the treatment of MDS. However, because of the dose-limiting toxicity of hypercalcemia, past clinical trials with vitamin D have been forced to utilize low doses, with promising but inconsistent results.
This study utilizes a dosing schema of dexamethasone (Dex) and calcitriol (the active form of vitamin D) that augments the therapeutic index of calcitriol, and allows for safe administration of 5-10 times higher dose of calcitriol than previously has been used in clinical trials for MDS. Patients will receive dexamethasone 4 times per week and calcitriol 3 times per week. This schedule will continue weekly until patients are off study. The dose of calcitriol will be increased until the maximum tolerated dose (MTD) is determined. History and physical examination, blood monitoring, urinary ultrasounds, and bone marrow aspirations and biopsies will be used to assess disease response.
- Conditions
- Myelodysplastic Syndromes
- Being tested
- Calcitriol, Dexamethasone
- Keywords
- Hematopoiesis, Apoptosis, Cell Differentiation, Bone Marrow Cells
- Medical subject headings
- Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CalcitriolDrug
DexamethasoneDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2002 (estimated)
- Study startSep 2001
- Primary completionSep 2007
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic SyndromesStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Redner, MD, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00030069
- Sponsor's protocol ID
- UPCI 01-020
- Other IDs
- FD-R-002025-01
- Status last verified
- Jan 2016
- First submitted
- 30 Jan 2002
- Last updated
- 15 Jan 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calcitriol and Dexamethasone for Myelodysplastic Syndromes
- ClinicalTrials.gov ID
- NCT00030069
- Acronym / sponsor ID
- UPCI 01-020
- Conditions
- Myelodysplastic Syndromes
- Keywords
- Hematopoiesis, Apoptosis, Cell Differentiation, Bone Marrow Cells
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Sep 2001
- Primary completion
- Sep 2007 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 31 Jan 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study to determine the response rate in patients with myelodysplastic syndromes treated with calcitriol and dexamethasone.
Detailed description
Current therapeutic options for myelodysplastic syndromes (MDS) are limited and, aside from bone marrow transplantation, none have proven superior to supportive measures alone. Preclinical investigations have indicated the potential therapeutic role for vitamin D in the treatment of MDS. However, because of the dose-limiting toxicity of hypercalcemia, past clinical trials with vitamin D have been forced to utilize low doses, with promising but inconsistent results.
This study utilizes a dosing schema of dexamethasone (Dex) and calcitriol (the active form of vitamin D) that augments the therapeutic index of calcitriol, and allows for safe administration of 5-10 times higher dose of calcitriol than previously has been used in clinical trials for MDS. Patients will receive dexamethasone 4 times per week and calcitriol 3 times per week. This schedule will continue weekly until patients are off study. The dose of calcitriol will be increased until the maximum tolerated dose (MTD) is determined. History and physical examination, blood monitoring, urinary ultrasounds, and bone marrow aspirations and biopsies will be used to assess disease response.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically confirmed refractory anemia (RA), RA with excess blasts (RAEB), RAEB in transformation (RAEB-IT), or ringed sideroblasts (RARS)
- Evidence of cytopenia affecting at least 1 hematological cell lineage
- Adequate liver and renal function
- ECOG 0-2
- Expected survival of at least 12 weeks
Key exclusion criteria (8 listed)
- Symptomatic coronary artery disease
- Uncontrolled diabetes mellitus
- Uncontrolled and symptomatic glaucoma
- History of dangerous reactions to steroid therapy
- Chemotherapy or any hematopoietic growth factor therapy within the past 8 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calcitriol | Drug | – |
| Dexamethasone | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Calcitriol and Dexamethasone in people with Myelodysplastic Syndromes, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2016.