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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Primary Myelofibrosis

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

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

Outcome Time Frame:

24 weeks

Safety Issue:

Yes

Principal Investigator

Meir Wetzler, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

I 154609

NCT ID:

NCT01014546

Start Date:

April 2010

Completion Date:

June 2014

Related Keywords:

  • Primary Myelofibrosis
  • JAK2 positive
  • Primary Myelofibrosis

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263