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Safety Study of Thioridazine in Combination With Cytarabine to Treat Relapsed or Refractory Acute Myeloid Leukemia

Information source: Ontario Clinical Oncology Group (OCOG)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Myeloid Leukemia

Intervention: Thioridazine (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: Ontario Clinical Oncology Group (OCOG)

Official(s) and/or principal investigator(s):
Mark N Levine, MD, Study Director, Affiliation: Ontario Clinical Oncology Group, McMaster University
Ronan Foley, MD, Principal Investigator, Affiliation: Hamilton Health Sciences, McMaster University

Overall contact:
Lisa Rudd-Scott, RN BScN MN, Phone: 905-527-2299, Ext: 43793, Email: ruddl@mcmaster.ca

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.

Clinical Details

Official title: A Phase I Trial Evaluating Oral Thioridazine in Combination With Intermediate Dose Cytarabine in Patients 55 Years and Older With Acute Myeloid Leukemia Who Have Relapsed or Have Refractory Disease

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

Primary outcome: Safety

Secondary outcome:

Assessment of Functional Leukemia Stem Cells

Pharmacokinetic Analysis of Thioridazine Serum Trough Levels

Assessment of Objective Tumor Response

Pharmacogenetic Analysis of Thioridazine Serum Trough Levels

Eligibility

Minimum age: 55 Years. Maximum age: 80 Years. Gender(s): 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.

Locations and Contacts

Lisa Rudd-Scott, RN BScN MN, Phone: 905-527-2299, Ext: 43793, Email: ruddl@mcmaster.ca

Juravinski Hospital & Cancer Centre, Hamilton, Ontario L8V 1C3, Canada; Recruiting
Ronan Foley, MD, Phone: 905-527-4322, Ext: 42074, Email: foleyr@hhsc.ca
Ronan Foley, MD, Principal Investigator
Additional Information

Starting date: July 2014
Last updated: April 13, 2015

Page last updated: August 23, 2015

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