Status:
TERMINATED
Study of Association of Arsenic Trioxide (ATO) and Ascorbic Acid in Myelodysplastic Syndromes
Lead Sponsor:
Fondazione Italiana Sindromi Mielodisplastiche-ETS
Collaborating Sponsors:
Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
Conditions:
Myelodysplastic Syndromes
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
This is a prospective, multicenter phase II trial designed to evaluate the safety and activity of the combination of association of arsenic trioxide (ATO) and ascorbic acid in patients with myelodyspl...
Eligibility Criteria
Inclusion
- Patients affected by myelodysplastic syndromes, entering in one of the following groups:
- Myelodysplastic syndromes independent of WHO diagnostic classification (43) and IPSS prognostic score (2), when present at least one of the following abnormalities:
- 3q26 chromosome rearrangement.
- High EVI-1 transcript levels.
- Myelodysplastic syndromes without excess of blasts (non-RAEB patients) at low or intermediate-1 score risk according to the IPSS (2), as a second line treatment option, after a failure to the first line treatment with erythropoietin +/- G-CSF, immunosuppressive therapy, or other initial treatment modality.
- Non RAEB patients at intermediate-2 or high risk score or RAEB patients at any prognostic score, who are non candidate to treatment with conventional chemotherapy regimens.
- Presence of one ore more cytopenias characterised by one ore more of the following elements:
- Transfusions dependence.
- Hb\< 11 gr/dl
- Platelet count \< 50x109/L
- Absolute neutrophil count \< .5x109/L.
- ECOG Performance status ≤ 2.
- Aged from 18 to 80.
- Life expectancy \> 4 months.
- Creatinine level \< 1.5 mg/dl.
- Liver function tests, including ASL-ALT-alkaline phosphatase lower than 3xULN
- No previous treatment with chemotherapy, growth factors, cytokines or other experimental treatment within 4 weeks of starting treatment.
- No history of clinically significant cardiac disease, including congestive heart failure.
- Cytogenetic evaluation available.
- Sending of both peripheral blood and bone marrow sample to the central laboratory for EVI-1 rearrangement evaluation.
- Written Informed consent.
Exclusion
- Patients affected by myelodysplastic syndromes entering in categories other than those foreseen by inclusion criteria point 1.
- Absence of cytopenia defined as the contemporarily presence of all the following conditions: a) no transfusion need; b) Hb \> 11 gr/dl; c) platelet count \> 50x109/L; d) absolute neutrophil count \> .5x109/L.
- All patients that might be candidate to allogenic stem cell transplantation.
- Patients that might be candidate to a first line immunosuppressive therapy.
- ECOG Performance status \> 2.
- Age lower than 18 or higher then 80.
- Life expectancy \< 4 months.
- Creatinine level \> 1.5 mg/dl.
- Liver function tests, including ASL-ALT-alkaline phosphatase higher than 3xULN
- Treatment with chemotherapy, growth factors, cytokines or other experimental treatment within 4 weeks of starting treatment.
- Clinically significant cardiac disease, including congestive heart failure, rhythm abnormalities, QT time \> 460m/s, or need of anti-arrhythmic drugs.
- Concurrent co-morbid medical condition which might exclude administration of therapy, as judged by individual investigator.
- Absence of cytogenetic evaluation.
- Participation at same time in another study in which investigational drugs are used.
- Absence of written Informed consent.
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2010
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT00803530
Start Date
September 1 2005
End Date
August 1 2010
Last Update
June 28 2011
Active Locations (13)
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1
Ospedale SS Antonio, Biagio e Cesare Arrigo
Alessandria, Italy
2
Ospedale Cardinal Massaia
Asti, Italy
3
Spedali Civili
Brescia, Italy
4
Ospedale Maggiore
Chieri, Italy