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

Information source: Roswell Park Cancer Institute
ClinicalTrials.gov processed this data on November 27, 2014
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Primary Myelofibrosis

Intervention: Dose Escalating Arsenic Trioxide plus ascorbic Acid (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: Roswell Park Cancer Institute

Official(s) and/or principal investigator(s):
Meir Wetzler, MD, Principal Investigator, Affiliation: Roswell Park Cancer Institute

Overall contact:
AskRPCI, Phone: 1-877-275-7724, Email: AskRPCI@roswellpark.org

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.

Clinical Details

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

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

Primary outcome: To determine the safety and maximum tolerated dose of oral arsenic trioxide with or without ascorbic acid is subjects with JAK2-positive myelofibrosis

Secondary outcome: To estimate the incidence, severity and attribution of treatment-emergent adverse events

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

AskRPCI, Phone: 1-877-275-7724, Email: AskRPCI@roswellpark.org

Roswell Park Cancer Institute, Buffalo, New York 14263, United States; Recruiting
Additional Information

Starting date: April 2010
Last updated: July 2, 2014

Page last updated: November 27, 2014

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