Safety Study of Thioridazine in Combination With Cytarabine to Treat Relapsed or Refractory Acute Myeloid Leukemia
Conditions
Acute Myeloid Leukemia
Conditions: official terms
Leukemia - Leukemia, Myeloid - Leukemia, Myeloid, Acute
Conditions: Keywords
Relapsed Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia, Thioridazine, Phase I, Clinical Trial
Study Type
Interventional
Study Phase
Phase 1
Study Design
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Thioridazine
Type: Drug
Overall Status
Recruiting
Summary
This is a Phase I trial investigating the safety of using thioridazine in addition to cytarabine in elderly patients with relapsed or refractory Acute Myeloid Leukemia.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 80 Years
Minimum Age: 55 Years
Gender: Both
Criteria: Inclusion Criteria:

- Have a diagnosis of AML according to the WHO Classification1

- AML is refractory or relapsed (requiring at least 5% leukemic blasts in the bone marrow, regardless of the presence of other features such as new or recurrent dysplastic changes or extra medullary disease) according to the following definitions:

- Relapsed (defined as ≥ 5% leukemic blasts in the bone marrow) after three months from receiving up to three prior induction regimens.

- Refractory (defined as ≥ 5% leukemic blasts in the bone marrow) to not more than one prior induction regimen (defined as failure to achieve a CR or CRi following induction therapy).

- 55 years of age or older.

Exclusion Criteria:

- Receiving any other systemic anti-leukemic therapy (standard or investigational).

- Having received more than two prior chemotherapy lines for AML. Induction/consolidation therapy and bone marrow transplant are each considered a line of therapy.

- Having received previous AML therapy within four weeks of the first dose of study drug, with the exception of hydroxyurea.

- Clinical evidence suggestive of CNS involvement with leukemia unless a lumbar puncture confirms the absence of leukemic blasts in the CSF.

- Acute promyelocytic leukemia.

- An ECOG performance status of 3 or more.

- Inadequate renal function (i.e., estimated GFR < 60 mL/min/1.73m2).

- Inadequate hepatic function (i.e., serum bilirubin > 1.5×ULN; AST, ALT and alkaline phosphatase > 2.5×ULN).

- Presence of acute or chronic GVHD.

- Presence of a systemic fungal, bacterial, viral or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).

- Having any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver or other organ system that may place the patient at undue risk to undergo induction therapy.

- Diagnosed with a condition that can prolong the QT interval (e.g., long QT syndrome) or have a QTc interval ≥ 470ms if male, or ≥ 480ms if female.

- Left ventricular ejection fraction less than 45%.

- History of uncontrolled cardiac arrhythmia.

- Known severe hypotensive or hypertensive heart disease.

- Prior malignancy, unless the patient has been disease-free for at least five years following curative intent therapy, with the following exceptions: Patients with treated non-melanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia, regardless of the disease-free duration, if definitive treatment for the condition has been completed; or patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease based on prostate-specific antigen (PSA) values if hormonal therapy has been initiated or a radical prostatectomy has been performed.

- Known HIV positivity.

- Known pregnancy or lactating female.

- Presence of a psychiatric disorder that would interfere with consent, study participation, or follow-up.

- Unable to provide informed consent.
Location
Juravinski Hospital & Cancer Centre
Hamilton, Ontario, Canada
Status: Recruiting
Contact: Ronan Foley, MD - 905-527-4322 - foleyr@hhsc.ca
Start Date
July 2014
Completion Date
January 2016
Sponsors
Ontario Clinical Oncology Group (OCOG)
Source
Ontario Clinical Oncology Group (OCOG)
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page