Study of Oral Arsenic Trioxide With or Without Ascorbic Acid in Adults With Myelofibrosis

This study is currently recruiting participants.
Verified December 2013 by Roswell Park Cancer Institute
Sponsor:
Collaborator:
Cephalon
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT01014546
First received: November 16, 2009
Last updated: December 26, 2013
Last verified: December 2013

November 16, 2009
December 26, 2013
April 2010
June 2014   (final data collection date for primary outcome measure)
To determine the safety and maximum tolerated dose of oral arsenic trioxide with or without ascorbic acid is subjects with JAK2-positive myelofibrosis [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
To determine the safety and maximum tolerated dose of oral arsenic trioxide with or without ascorbic acid is subjects with JAK2-positive myelofibrosis [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01014546 on ClinicalTrials.gov Archive Site
To estimate the incidence, severity and attribution of treatment-emergent adverse events [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
To estimate the incidence, severity and attribution of treatment-emergent adverse events [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Study of Oral Arsenic Trioxide With or Without Ascorbic Acid in Adults With Myelofibrosis
A Phase I Study of Oral Arsenic Trioxide With or Without Ascorbic Acid in Adults With JAK2-Positive Myelofibrosis

This study determine the highest safe dose of arsenic trioxide with or without ascorbic acid and if the investigational drug arsenic trioxide along with ascorbic acid (vitamin C) is effective against JAK2 positive myelofibrosis.

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Primary Myelofibrosis
Drug: Dose Escalating Arsenic Trioxide plus ascorbic Acid
Dose Escalating Arsenic Trioxide starting at 0.15mg/kg plus 1000 mg dose of ascorbic acid
Experimental: Arsenic Trioxide & Ascorbic Acid
Arsenic Trioxide dose 0.15mg/kg to 0.55mg/kg with the addition of ascorbic acid (1,000 mg total dose)
Intervention: Drug: Dose Escalating Arsenic Trioxide plus ascorbic Acid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
June 2014
June 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of primary myelofibrosis, essential thrombocythemia related myelofibrosis or polycythemia vera related myelofibrosis requiring therapy including previously treated and relapsed or refractory or newly diagnosed or with symptomatic splenomegaly or if newly diagnosed, with intermediate or high risk or with symptomatic splenomegaly
  • Detectable JAK2 V617F mutation
  • Signed Informed Consent: Patients must have signed consents for both the arsenic trioxide with ascorbic acid protocol and for the Hematologic Malignancy Procurement protocol to be eligible to participate.
  • Must have been off any experimental PMF-directed therapy for 4 weeks prior to entering study and have recovered from the toxic effects of that therapy Treatment with hydroxyurea and erythropoetin are permitted until study initiation.
  • Serum bilirubin levels <2 X Upper Limits of Normal
  • Serum SGPT and ALT levels <2 X Upper Limits of Normal
  • Serum creatinine levels <1.5 X Upper Limits of Normal
  • Negative pregnancy Test
  • At least 18 years old

Exclusion Criteria:

  • Nursing and pregnant females
  • NYHA Grade II or greater congestive heart failure
  • Unstable angina
  • QTc >450 in the presence of potassium >4 mEq/L and magnesium >1.5mEq/L
  • ECOG > 2
  • Major surgical procedure within 28 days of entering the study
  • Biopsy or minor surgical procedure within 7 days prior to study enrollment
  • Known hypersensitivity to any compound of arsenic trioxide
  • Ongoing serious, Non-healing wound, ulcer or bone fracture
Both
18 Years and older
No
Contact: AskRPCI 1-877-275-7724 AskRPCI@roswellpark.org
United States
 
NCT01014546
I 154609
Yes
Roswell Park Cancer Institute
Roswell Park Cancer Institute
Cephalon
Principal Investigator: Meir Wetzler, MD Roswell Park Cancer Institute
Roswell Park Cancer Institute
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP