Overview
Arsenic Trioxide With or Without Ascorbic Acid in Treating Patients With Myelofibrosis
Status:
Terminated
Terminated
Trial end date:
1969-12-31
1969-12-31
Target enrollment:
0
0
Participant gender:
All
All
Summary
This phase I trial studies the side effects and best dose of arsenic trioxide with or without ascorbic acid in treating patients with myelofibrosis. Drugs used in chemotherapy, such as arsenic trioxide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving arsenic acid together with ascorbic acid may kill more cancer cells.Phase:
Phase 1Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Roswell Park Cancer InstituteCollaborators:
Cephalon
National Cancer Institute (NCI)Treatments:
Arsenic Trioxide
Ascorbic Acid
Vitamins
Criteria
Inclusion Criteria:- Diagnosis of primary myelofibrosis, essential thrombocythemia related myelofibrosis,
or polycythemia vera related myelofibrosis requiring therapy, including:
- Those previously treated and relapsed or refractory
- Or, if newly diagnosed, with intermediate or high risk according to Lille scoring
system (adverse prognostic factors are: hemoglobin [Hb] < 10 g/dl, white blood
cell count [WBC] < 4 or > 30 x 10^9/L; risk group: 0 = low, 1 = intermediate, 2 =
high)
- Or with symptomatic splenomegaly (must be >= 23 cm by ultrasound in the
longitudinal axis)
- 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
- Patients must have been off any primary myelofibrosis (PMF)-directed experimental
therapy for 4 weeks prior to entering this study and have recovered from the toxic
effects (grade 0-1) of that therapy; treatment with hydroxyurea and erythropoietin are
permitted until study initiation
- Serum bilirubin levels =< 2 times the upper limit of the normal range for the
laboratory (ULN); higher levels are acceptable if these can be attributed by treating
physician to active hemolysis or ineffective erythropoiesis due to myelofibrosis
- Serum glutamic-pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) levels =<
2 x ULN
- Serum creatinine levels =< 1.5 x ULN
- Women of childbearing potential must have a negative serum or urine pregnancy test
prior to arsenic trioxide treatment and should be advised to avoid becoming pregnant
- Men must be advised to not father a child while receiving treatment with arsenic
trioxide
- Both women of childbearing potential and men must practice effective methods of
contraception (those generally accepted as standard of care measures)
- Women of childbearing potential are women who are not menopausal for 12 months or who
have not undergone previous surgical sterilization
- If the subject is a woman of childbearing potential, she must use a medically
acceptable form of contraception during the study period and for 30 days thereafter
- If the subject is a man he must be surgically sterile or must use a medically approved
method of contraception for the duration of the study and for 60 days following the
last dose of arsenic trioxide
Exclusion Criteria:
- Nursing and pregnant females; should a woman become pregnant or suspects she is
pregnant while participating in this study, she should inform her treating physician
immediately
- New York Heart Association (NYHA) grade II or greater congestive heart failure
- Unstable angina
- Corrected QT interval (QTc) > 450 in the presence of potassium >= 4 mEq/L and
magnesium >= 1.7 mEq/L
- Eastern Cooperative Oncology Group (ECOG) > 2
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days,
or anticipation of the need for major surgical procedure during the course of the
study
- Biopsy or other minor surgical procedure, excluding placement of a vascular access
device or bone marrow biopsy, within 7 days prior to study enrollment
- Ongoing serious, non-healing wound, ulcer, or bone fracture
- Known hypersensitivity to any component of arsenic trioxide