Study of Oral Arsenic Trioxide With or Without Ascorbic Acid in Adults With Myelofibrosis
Information source: Roswell Park Cancer Institute
Information obtained from ClinicalTrials.gov on February 07, 2013
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: January 9, 2013
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