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

This study is currently recruiting participants.

Verified March 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: March 6, 2013

Last verified: March 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

November 16, 2009

Last Updated Date

March 6, 2013

Start Date ^ICMJE

April 2010

Estimated Primary Completion Date

June 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

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 ]

Change History

Complete list of historical versions of study NCT01014546 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To estimate the incidence, severity and attribution of treatment-emergent adverse events [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

To estimate the incidence, severity and attribution of treatment-emergent adverse events [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Phase I Study of Oral Arsenic Trioxide With or Without Ascorbic Acid in Adults With JAK2-Positive Myelofibrosis

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Primary Myelofibrosis

Intervention ^ICMJE

Drug: Dose Escalating Arsenic Trioxide plus ascorbic Acid

Dose Escalating Arsenic Trioxide starting at 0.15mg/kg plus 1000 mg dose of ascorbic acid

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

June 2014

Estimated Primary Completion Date

June 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: AskRPCI

1-877-275-7724

AskRPCI@roswellpark.org

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01014546

Other Study ID Numbers ^ICMJE

I 154609

Has Data Monitoring Committee

Yes

Responsible Party

Roswell Park Cancer Institute

Study Sponsor ^ICMJE

Roswell Park Cancer Institute

Collaborators ^ICMJE

Cephalon

Investigators ^ICMJE

Principal Investigator:

Meir Wetzler, MD

Roswell Park Cancer Institute

Information Provided By

Roswell Park Cancer Institute

Verification Date

March 2013

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

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