Expired Study
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New York, New York 10021


Purpose:

This is an open-label, one arm, single institution study. Arsenic trioxide [TrisenoxTM Injection], 0.25mg/kg/dose administered intravenously over 2 hours. 20 patients Complete remission, partial remission, clinical improvement, progressive disease, stable disease, relapse (per IWG consensus criteria, 2006) Clinical chemistry, hematology and ECGs will be assessed at least weekly during study treatments. Adverse events will be assessed in accordance with the NCI Common Toxicity Criteria, Version 2 at each study visit.


Criteria:

Inclusion Criteria: 1. Patients > = 18 years with a documented history of myelofibrosis transformed to acute myeloid leukemia using the World Health Organization criteria of > = 20% blasts in the peripheral blood or bone marrow; the diagnosis of myelofibrosis could be either primary myelofibrosis (myelofibrosis with myeloid metaplasia, agnogenic myeloid metaplasia), post-polycythemia vera or post-essential thrombocytosis. 2. Patients > = 18 years with myelofibrosis (either primary (myelofibrosis with myeloid metaplasia, agnogenic myeloid metaplasia), post polycythemia vera or post essential thrombocytosis) who 1) meet the Mayo Clinic criteria for high risk disease (> = 2 of the following criteria: hemoglobin <10 g/dL, WBC <4 or >30 x 109/L, platelets < 100 x 109/L, absolute monocyte count > = 1 x 109/L) AND 2) have failed to respond to treatment with at least one prior therapy for myelofibrosis (erythropoietic cytokines, androgens, hydrea, interferon, thalidomide, lenalidomide or investigational therapy). 3. Patients must have discontinued prior myelofibrosis treatments (with the exception of hydrea, which is permitted for control of leukocytosis) for at least 14 days prior to starting study drug 4. ECOG performance status of < = 2 5. Serum creatinine < = 2.5 times the upper limit of normal 6. Serum bilirubin < = 2.5 times the upper limit of normal 7. Serum potassium >4.0 mEq/dL and serum magnesium >2.0 mg/dL. If these serum electrolytes are below the specified limits on the baseline laboratory tests, electrolytes will be administered to bring the serum concentrations to these levels before administering arsenic trioxide. 8. Patients will be eligible for this trial regardless of gender, racial/ethnic background, provided all other inclusion and exclusion criteria are met and the patient or patient's legally authorized guardian signs the informed consent. Exclusion Criteria: 1. Pregnant or lactating women 2. Presence of a (9;22) translocation cytogenetically, or presence of bcr-abl by FISH (fluorescence in situ hybridization) or PCR (polymerase chain reaction) 3. Absolute QT interval >500 msec in the presence of serum potassium ≥ 4.0 mEq/L and magnesium > = 1.8 mg/dL. 4. Prior cytotoxic chemotherapy for AML or MDS; prior treatment with hydroxyurea, 5-azacytidine, decitabine, thalidomide and lenalidomide are permitted. Prior treatment with low-dose cytarabine is not permitted. 5. Concurrent treatment with maintenance therapy, cytotoxic chemotherapy, radiation, or investigational agents. 6. Uncontrolled or severe cardiovascular, pulmonary or infectious disease or other medical condition that would prohibit use of the planned study treatments. 7. Inability or unwillingness to comply with the treatment protocol, follow-up, or research tests.


Study is Available At:


Original ID:

0707009291


NCT ID:

NCT00572065


Secondary ID:


Study Acronym:


Brief Title:

Pilot Trial of Arsenic + Cytarabine in Patients With Myelofibrosis


Official Title:

Prospective Pilot Trial of Arsenic Trioxide (Trisenox®) in Combination With Cytosine Arabinoside in Patients With Advanced or Transformed Myelofibrosis


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Weill Medical College of Cornell University


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

21


Enrollment Type:

Actual


Overall Contact Information

Official Name:Gail Roboz, MD
Principal Investigator
Weill Medical College of Cornell University

Study Dates

Start Date:February 29, 2008
Completion Date:February 8, 2010
Completion Type:Actual
Primary Completion Date:December 2009
Primary Completion Type:Actual
Verification Date:March 2017
Last Changed Date:March 2, 2017
First Received Date:December 11, 2007

Study Outcomes

Outcome Type:Primary Outcome
Measure:To assess the response rate in patients with advanced MF/LT using criteria of the International Working Group (IWG)
Time Frame:duration of study
Safety Issues:False
Outcome Type:Primary Outcome
Measure:To characterize the safety and tolerability of the regimen in this patient population
Time Frame:duration of study
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:To assess overall survival
Time Frame:duration of study
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:arsenic trioxide
Description:Cytarabine will be administered at a dose of 10 mg/m2 subcutaneously (sc) twice daily (bid) from days 1-14. Triseonx will be administered at a dose of 0.25 mg/kg on days 1-5 and days 8-12. Trisenox will be restarted only when the QT interval returns to less than 500 msec. One treatment cycle consists of 2 weeks, with 14 days of cytarabine and 10 days of ATO. Subsequent cycles will be administered at the investigator's discretion, depending on response and tolerability. Patients may continue to
Arm Name:All Patients
Intervention Type:Drug
Name:cytarabine
Description:Cytarabine will be administered at a dose of 10 mg/m2 subcutaneously (sc) twice daily (bid) from days 1-14. Trisenox will be administered at a dose of 0.25 mg/kg on days 1-5 and days 8-12. Trisenox will be restarted only when the QT interval returns to less than 500 msec. One treatment cycle consists of 2 weeks, with 14 days of cytarabine and 10 days of ATO. Subsequent cycles will be administered at the investigator's discretion, depending on response and tolerability. Patients may continue to
Arm Name:All Patients
Other Name:cytosine arabinoside

Study Arms

Study Arm Type:Experimental
Arm Name:All Patients
Description:Arsenic trioxide [TrisenoxTM Injection], will be administered at a dose of 0.25 mg/kg on days 1-5 and days 8-12.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Weill Medical College of Cornell University

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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