Dandelion Root Extract in Patients with Refractory Hematologic Malignancies

Official Title

Dandelion Root Extract in Patients with Refractory Hematologic Malignancies

Summary:

Thirty patients with refractory (end stage) blood related cancers (lymphoma, leukemia, myelodysplastic syndromes) will be entered into the protocol in groups of three.  Each subsequent group of three will have an increase in the dose of DRE until unacceptable side effects are experience by at least two out of the three in that group.  Unacceptable side effects include admission to hospital for side effects related to the drug, death or inability to consume the recommended dose.  Once dose limiting toxicity is identified, we move back to dose level previous to the one that causes the serious event, and that will be the recommended dose.

Trial Description

Primary Outcomes: 

• To define the recommended dose of DRE consumed orally.

Secondary Outcomes: 

• To evaluate the toxicity of DRE and their reversibility, association with dose in this same patient population.
• To assess preliminary evidence of antitumour effects in those patients with measureable disease by documentation of objective responses using NCI criteria in patients with refractory hematologic malignancies who are receiving single agent DRE.  
• To measure the effect of the DRE on caspase activity in the blood cells of leukemia patients receiving the DRE.  Correlation to know molecular factors will be performed where available (eg JAK2, cytogenetics, PLK-1). 
• Variables to be assessed include concomitant medications, concomitant complementary medicines, patient co-morbidities, number of prior therapies and the type and stage of cancer.

The design of this dose-finding phase I clinical trial was chosen to assess the DRE in the treatment of patients with refractory hematologic malignancies.  Patients will be eligible for this study if they have a refractory hematologic malignancy and have exhausted all standard medical treatments for their cancer.  Patients must not be pregnancy and must be at least 18 years of age and not over 70 years of age.  Patients cannot have significant comorbidites that would increase the risk of death or toxicity from this product.  They must be capable of adhering to the protocol.

The starting dose of DRE will be 1000 mg daily which will be provided by Dr. Pandey's lab at University of Windsor.  Patient will receive their supply of DRE at the beginning of each week.  This product will be dissolved in 125 cc of cold water or hot water and consume this in less than 1 hour.   Honey, sugar or sweetener may be added to the product to improve tolerability.   There is no premedication.  The first 3 patients will start off at level 1 with 2 aliquots per day, taking 1 in the morning and the 2nd in the evening.  The rate of subject entry and escalation to the next dose level will depend on assessment of the safety profile of patients entered at the previous dose level.  Toxicity will be evaluated according to NCIC CTCAE v 3.0.  Three patients within a dose level must be observed for one cycle (28 days) before accrual to the next higher dose level. Patients will remain on the DRE until progression of disease or until they develop unacceptable toxicity or withdraw from the study if they choose.