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Study of Association of Arsenic Trioxide (ATO) and Ascorbic Acid in Myelodysplastic Syndromes

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ClinicalTrials.gov Identifier: NCT00803530
Recruitment Status : Terminated (difficulties of enrollement)
First Posted : December 5, 2008
Last Update Posted : June 28, 2011
Sponsor:
Collaborator:
Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
Information provided by:
Fondazione Italiana Sindromi Mielodisplastiche Onlus

Study Description
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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 myelodysplastic syndromes

Condition or disease Intervention/treatment Phase
Myelodysplastic Syndromes Drug: ATO + Ascorbic acid Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Multicenter Study of Association of Arsenic Trioxide (ATO) and Ascorbic Acid in Myelodysplastic Syndromes
Study Start Date : September 2005
Actual Primary Completion Date : January 2007
Actual Study Completion Date : August 2010

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 1

Loading phase (week 1): ATO 0.3 mg/Kg/die for 5 consecutive days.

  • Subsequent phase (from week 2 to week 16): ATO 0.25 mg/kg twice a week (day 2 and 5 of every week).
  • Ascorbic acid 1000 mg IV within 30 minutes after each arsenic trioxide infusion for 16 consecutive weeks.
 Drug: ATO + Ascorbic acid

ATO will be diluted in 250 ml of normal saline solution at a dosage of 0.3 mg/Kg during the first week of therapy and at a dosage of 0.25 mg/Kg during the subsequent weeks (week 2 to 16), and administered intravenously over a 1-2 hour period.

The dose of ascorbic acid will be 1000 mg in 100 cc D5W or normal saline solution (NaCl 0.9 %) (protected from light and air) administered as an IV infusion over 15 to 30 minutes. The dosing solution is not to be mixed with any alkaline solution.


Outcome Measures
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Primary Outcome Measures :
  1. TO evaluate the erythroid response rate (major), according to the International Working Group (IWG) criteria (42) after four months of treatment with the association of ATO and ascorbic acid. [ Time Frame: 16 mounths ]

Secondary Outcome Measures :
  1. To evaluate platelets and granulocyte response according to the International Working Group (IWG) criteria (42) after four months of treatment with the association of ATO and ascorbic acid [ Time Frame: 16 mounths ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients affected by myelodysplastic syndromes, entering in one of the following groups:

    1. 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.
    2. 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.
    3. 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.

  2. 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.
  3. ECOG Performance status ≤ 2.
  4. Aged from 18 to 80.
  5. Life expectancy > 4 months.
  6. Creatinine level < 1.5 mg/dl.
  7. Liver function tests, including ASL-ALT-alkaline phosphatase lower than 3xULN
  8. No previous treatment with chemotherapy, growth factors, cytokines or other experimental treatment within 4 weeks of starting treatment.
  9. No history of clinically significant cardiac disease, including congestive heart failure.
  10. Cytogenetic evaluation available.
  11. Sending of both peripheral blood and bone marrow sample to the central laboratory for EVI-1 rearrangement evaluation.
  12. Written Informed consent.

Exclusion Criteria:

  1. Patients affected by myelodysplastic syndromes entering in categories other than those foreseen by inclusion criteria point 1.
  2. 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.
  3. All patients that might be candidate to allogenic stem cell transplantation.
  4. Patients that might be candidate to a first line immunosuppressive therapy.
  5. ECOG Performance status > 2.
  6. Age lower than 18 or higher then 80.
  7. Life expectancy < 4 months.
  8. Creatinine level > 1.5 mg/dl.
  9. Liver function tests, including ASL-ALT-alkaline phosphatase higher than 3xULN
  10. Treatment with chemotherapy, growth factors, cytokines or other experimental treatment within 4 weeks of starting treatment.
  11. Clinically significant cardiac disease, including congestive heart failure, rhythm abnormalities, QT time > 460m/s, or need of anti-arrhythmic drugs.
  12. Concurrent co-morbid medical condition which might exclude administration of therapy, as judged by individual investigator.
  13. Absence of cytogenetic evaluation.
  14. Participation at same time in another study in which investigational drugs are used.
  15. Absence of written Informed consent.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00803530


Locations
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Italy
Ospedale SS Antonio, Biagio e Cesare Arrigo
Alessandria, Italy
Ospedale Cardinal Massaia
Asti, Italy
Spedali Civili
Brescia, Italy
Ospedale Maggiore
Chieri, Italy
Ospedale civico di Chivasso
Chivasso (TO), Italy
Ospedale Santa Croce e Carle
Cuneo, Italy
AOS San Gerardo de' Tintori
Monza, Italy
Università Avogadro Divisione di Ematologia
Novara, Italy
Ospedale San Luigi Gonzaga Divisione di Ematologia
Orbassano (TO), Italy
Azienda Ospedaliera Perugia
Perugia, Italy
Ospedale San Giovanbni Battista-Molinette
Torino, Italy
Ospedale San Giovanni Battista -Molinette
Torino, Italy
Ospedale San Bortolo
Vicenza, Italy
Sponsors and Collaborators
Fondazione Italiana Sindromi Mielodisplastiche Onlus
Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
Investigators
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Study Director: Alessandro Levis, MD S.O.C. di Ematologia, Azienda Ospedaliera SS Antonio e Biagio, Alessandria. Via Venezia 18 - 15100 - Alessandria
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Alessandro Levis, Azienda Ospedaliera SS Antonio e Biagio, Alessandria.
ClinicalTrials.gov Identifier: NCT00803530     History of Changes
Other Study ID Numbers: AISSM02A
EudracT Number 2005-001321-28
First Posted: December 5, 2008    Key Record Dates
Last Update Posted: June 28, 2011
Last Verified: June 2011
Keywords provided by Fondazione Italiana Sindromi Mielodisplastiche Onlus:
myelodysplastic syndromes
arsenic trioxide
ascorbic acid
Additional relevant MeSH terms:
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Preleukemia
Myelodysplastic Syndromes
Syndrome
Disease
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Ascorbic Acid
 Arsenic Trioxide
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Nutrients
Growth Substances
Antineoplastic Agents