LeukemiaPhase 1NCT00004245
Sodium Salicylate in Treating Patients With Advanced Myelodysplastic Syndrome, Acute Myelogenous Leukemia, or Chronic Lymphocytic Leukemia
A Phase 1 study testing sodium salicylate in people with Leukemia and Myelodysplastic Syndromes, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of sodium salicylate in treating patients who have advanced myelodysplastic syndrome , acute myelogenous leukemia or chronic lymphocytic leukemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms
- What is being tested?
- sodium salicylate
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Aug 1999to Sep 2004
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Relapsed or refractory acute myelogenous leukemia OR
- Elderly patients with newly diagnosed acute myelogenous leukemia not eligible for standard therapy OR
- "High-risk" myelodysplastic syndrome, including:
- Refractory anemia with excess blasts
- Refractory anemia with excess blasts in transformation
- Chronic myelomonocytic leukemia OR
- Relapsed or refractory chronic lymphocytic leukemia
- Not eligible for transplant protocols at MSKCC or refuses transplant
- Not eligible for a higher priority protocol (e.g., bone marrow transplantation)
PATIENT CHARACTERISTICS:
Age:
- Over 18
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Platelet count at least 25,000/mm^3
Hepatic:
- Bilirubin no greater than 2.0 mg/dL
- Transaminase levels less than 3 times upper limit of normal
- PT no greater than 14 seconds
- PTT no greater than 34.6 seconds
Renal:
- Creatinine no greater than 2.0 mg/dL OR
- Creatinine clearance greater than 60 mL/min
Other:
- Not pregnant or nursing
- No history of abnormal bleeding or unexplained bleeding disorders
- No history of peptic ulcer disease
- No salicylate allergy
- No other concurrent active malignancy
- No other concurrent illness that would preclude study assessment to a significant degree
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- See Disease Characteristics
Chemotherapy:
- Not specified
Endocrine therapy:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- Not specified
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
About this study
Official title: A Phase I Study of Salicylate for Adult Patients With Advanced Myelodysplastic Disorders or Acute Myelogenous Leukemia
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of sodium salicylate in treating patients who have advanced myelodysplastic syndrome , acute myelogenous leukemia or chronic lymphocytic leukemia.
Read the detailed description
OBJECTIVES:
- Evaluate the safety, toxicity, and pharmacokinetics of sodium salicylate in patients with advanced myelodysplastic syndrome; newly diagnosed, relapsed, or refractory acute myelogenous leukemia; or relapsed or refractory chronic lymphocytic leukemia.
- Define biologic characteristics that influence the likelihood of a clinical response to this drug in this patient population.
OUTLINE: Patients receive oral sodium salicylate twice a day. Intrapatient dose escalation or de-escalation is permitted. Treatment continues for up to 6 weeks in the absence of unacceptable toxicity or disease progression. Responding patients may continue to receive sodium salicylate beyond the 6-week period.
Patients with acute myelogenous leukemia are followed until the end of therapy. Patients with myelodysplastic syndrome are followed until death or progression to leukemia.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study within 1 year.
- Being tested
- sodium salicylate
- Keywords
- recurrent adult acute myeloid leukemia, refractory chronic lymphocytic leukemia, untreated adult acute myeloid leukemia, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, chronic myelomonocytic leukemia, previously treated myelodysplastic syndromes, atypical chronic myeloid leukemia, BCR-ABL1 negative, myelodysplastic/myeloproliferative neoplasm, unclassifiable, adult acute myeloid leukemia with t(8;21)(q22;q22), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with t(15;17)(q22;q12)
- Medical subject headings
- Leukemia, Myelodysplastic Syndromes, Myelodysplastic-Myeloproliferative Diseases, Leukemia, Myeloid, Acute, Leukemia, Lymphocytic, Chronic, B-Cell, Anemia, Refractory, with Excess of Blasts, Leukemia, Myelomonocytic, Chronic, Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sodium salicylateDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startAug 1999
- Primary completionSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer 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 1
- Primary purpose
- Treatment
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Virginia Klimek, MD, Study chair, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004245
- Sponsor's protocol ID
- 99-057
- Other IDs
- P30CA008748, MSKCC-99057, NCI-G99-1661
- Status last verified
- Jan 2013
- First submitted
- 28 Jan 2000
- Last updated
- 18 Jan 2013
- Results posted
- No
Publications
Klimek VM, Dolezal EK, Smith L, Soff G, Nimer SD. Phase I trial of sodium salicylate in patients with myelodysplastic syndromes and acute myelogenous leukemia. Leuk Res. 2012 May;36(5):570-4. doi: 10.1016/j.leukres.2011.10.023. Epub 2011 Dec 9.
PubMed 22154022
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Salicylate for Adult Patients With Advanced Myelodysplastic Disorders or Acute Myelogenous Leukemia
- ClinicalTrials.gov ID
- NCT00004245
- Acronym / sponsor ID
- 99-057
- Keywords
- recurrent adult acute myeloid leukemia, refractory chronic lymphocytic leukemia, untreated adult acute myeloid leukemia, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, chronic myelomonocytic leukemia, previously treated myelodysplastic syndromes, atypical chronic myeloid leukemia, BCR-ABL1 negative
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 1999
- Primary completion
- Sep 2004 (actual)
- First posted
- 27 Jan 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: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of sodium salicylate in treating patients who have advanced myelodysplastic syndrome , acute myelogenous leukemia or chronic lymphocytic leukemia.
Detailed description
OBJECTIVES:
- Evaluate the safety, toxicity, and pharmacokinetics of sodium salicylate in patients with advanced myelodysplastic syndrome; newly diagnosed, relapsed, or refractory acute myelogenous leukemia; or relapsed or refractory chronic lymphocytic leukemia.
- Define biologic characteristics that influence the likelihood of a clinical response to this drug in this patient population.
OUTLINE: Patients receive oral sodium salicylate twice a day. Intrapatient dose escalation or de-escalation is permitted. Treatment continues for up to 6 weeks in the absence of unacceptable toxicity or disease progression. Responding patients may continue to receive sodium salicylate beyond the 6-week period.
Patients with acute myelogenous leukemia are followed until the end of therapy. Patients with myelodysplastic syndrome are followed until death or progression to leukemia.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study within 1 year.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- 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 |
|---|---|---|
| sodium salicylate | 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 18 Jan 2013.
- Results publication: PubMed 22154022Klimek VM, Dolezal EK, Smith L, Soff G, Nimer SD. Phase I trial of sodium salicylate in patients with myelodysplastic syndromes and acute myelogenous leukemia. Leuk Res. 2012 May;36(5):570-4. doi: 10.1016/j.leukres.2011.10.023. Epub 2011 Dec 9.
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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.
Virginia Klimek, MD study chair
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing sodium salicylate in people with Leukemia and Myelodysplastic Syndromes, run by Memorial Sloan Kettering Cancer 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 18 Jan 2013. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
On the ClinicalTrials.gov record for NCT00004245, which also lists 1 linked publication.
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 18 Jan 2013.