LeukemiaPhase 2NCT00064376
Paricalcitol in Treating Patients With Myelodysplastic Syndrome
A Phase 2 study testing paricalcitol in people with Leukemia and Myelodysplastic Syndromes, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
RATIONALE: Paricalcitol is a form of vitamin D that may help myelodysplastic cells develop into normal bone marrow cells. PURPOSE: Phase II trial to study the effectiveness of paricalcitol in treating patients who have myelodysplastic syndrome. Read more about this study
- Who is it for?
- Ages 25 to 100 years
- Conditions the study is for
- Leukemia, Myelodysplastic Syndromes
- What is being tested?
- paricalcitol
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- May 2003to Nov 2005
- 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 25 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Clinical diagnosis of myelodysplastic syndromes according to the modified FAB classification
- Confirmed by bone marrow aspiration showing blast and promyelocyte count no greater than 30% of the bone marrow differential
- Patients with refractory anemia with ringed sideroblasts are eligible provided there was no response to a 3-week course of prior high-dose pyridoxine
PATIENT CHARACTERISTICS:
Age
- 25 to 100
Performance status
- Karnofsky 60-100%
Life expectancy
- At least 12 weeks
Hematopoietic
- See Disease Characteristics
Hepatic
- Bilirubin less than 2.0 mg/dL
Renal
- Creatinine less than 2.5 mg/dL
- Calcium normal
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No prior sensitivity to paricalcitol or any component of its formulation
- No prior cholecalciferol toxicity
- No other concurrent acute illness
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- More than 5 weeks since prior chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- More than 5 weeks since prior radiotherapy
Surgery
- Prior recent surgery allowed, if fully recovered
Other
- More than 5 weeks since prior megadose vitamins
- No concurrent cholecalciferol, phosphate, calcium, or cholestyramine
- No concurrent digoxin
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: A Phase II Trial Of Paricalcitol In Myelodysplastic Syndromes
RATIONALE: Paricalcitol is a form of vitamin D that may help myelodysplastic cells develop into normal bone marrow cells.
PURPOSE: Phase II trial to study the effectiveness of paricalcitol in treating patients who have myelodysplastic syndrome.
Read the detailed description
OBJECTIVES:
- Determine the clinical effects of paricalcitol in patients with myelodysplastic syndromes.
- Determine whether this drug can improve RBC, WBC, or platelet counts in these patients.
- Determine whether this drug can decrease the risk of development of leukemia without causing undue toxicity in these patients.
OUTLINE: Patients receive oral paricalcitol daily for 4 months in the absence of disease progression or unacceptable toxicity.
Patients are followed at 1 month.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study within 8 months.
- Conditions
- Leukemia, Myelodysplastic Syndromes
- Being tested
- paricalcitol
- Keywords
- de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes, refractory anemia with excess blasts in transformation, refractory anemia with excess blasts, refractory anemia with ringed sideroblasts, refractory anemia, chronic myelomonocytic leukemia
- Medical subject headings
- Leukemia, Myelodysplastic Syndromes, Anemia, Refractory, with Excess of Blasts, Anemia, Refractory, Leukemia, Myelomonocytic, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paricalcitolDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2003 (estimated)
- Study startMay 2003
- Primary completionNov 2005
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe 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
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Principal investigator, H. Phillip Koeffler, Cedars-Sinai Medical Center
- Investigators
- H. Phillip Koeffler, MD, Study chair, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00064376
- Sponsor's protocol ID
- CDR0000315451
- Other IDs
- CSMC-IRB-4107-01
- Status last verified
- Jan 2018
- First submitted
- 8 Jul 2003
- Last updated
- 29 Jan 2018
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial Of Paricalcitol In Myelodysplastic Syndromes
- ClinicalTrials.gov ID
- NCT00064376
- Acronym / sponsor ID
- CDR0000315451
- Conditions
- Leukemia, Myelodysplastic Syndromes
- Keywords
- de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes, refractory anemia with excess blasts in transformation, refractory anemia with excess blasts, refractory anemia with ringed sideroblasts, refractory anemia, chronic myelomonocytic leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- May 2003 (actual)
- Primary completion
- Nov 2005 (actual)
- Study completion
- Nov 2005 (actual)
- First posted
- 9 Jul 2003 (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.
RATIONALE: Paricalcitol is a form of vitamin D that may help myelodysplastic cells develop into normal bone marrow cells.
PURPOSE: Phase II trial to study the effectiveness of paricalcitol in treating patients who have myelodysplastic syndrome.
Detailed description
OBJECTIVES:
- Determine the clinical effects of paricalcitol in patients with myelodysplastic syndromes.
- Determine whether this drug can improve RBC, WBC, or platelet counts in these patients.
- Determine whether this drug can decrease the risk of development of leukemia without causing undue toxicity in these patients.
OUTLINE: Patients receive oral paricalcitol daily for 4 months in the absence of disease progression or unacceptable toxicity.
Patients are followed at 1 month.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study within 8 months.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 25 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| paricalcitol | 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 29 Jan 2018.
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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.
H. Phillip Koeffler, MD study chair
Cedars-Sinai Medical Center
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 paricalcitol in people with Leukemia and Myelodysplastic Syndromes, run by Cedars-Sinai Medical Center 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?
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 29 Jan 2018. 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 29 Jan 2018.