Granulocyte-colony Stimulating Factor (G-CSF) and Plerixafor Plus Sorafenib for Acute Myelogenous Leukemia (AML) With FLT3 Mutations
The goal of this clinical research study is to learn the most tolerable dose of Nexavar (sorafenib) when given in combination with Mobozil (plerixafor) and Neupogen (filgrastim) to patients with AML. The safety of this combination will also be studied.
Funding Source - FDA Office of Orphan Product Development (OOPD).
Acute Myelogenous Leukemia
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||G-CSF and Plerixafor With Sorafenib for Acute Myelogenous Leukemia With FLT3 Mutations|
- Maximum Tolerated Dose (MTD) of Sorafenib [ Time Frame: Participant toxicity rates evaluated at 8 weeks of treatment (2 cycles) ] [ Designated as safety issue: Yes ]MTD dose level of Sorafenib where less than two participants (2/3) experience Dose limiting toxicity (DLT), based on Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, is defined as ± Grade 3 nonhematological toxicity or nausea/vomiting (in the absence of appropriate antiemetics) that cannot be explained by intercurrent conditions such as infections and at least possibly related to the combination of agents in study.
|Study Start Date:||October 2010|
|Estimated Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
Experimental: G-CSF and Plerixafor with Sorafenib
G-CSF 10 mcg/kg adjusted body weight subcutaneous injection. Plerixafor fixed dose of 240 mcg/kg adjusted body weight subcutaneous injection in abdomen. Patients will receive the 1st doses of G-CSF and Plerixafor on day 1. G-CSF and Plerixafor every other day for 7 total doses, repeated every 28 days. Sorafenib starting dose 400 mg twice daily orally after G-CSF/Plerixafor injections.
10 microgram/kg subcutaneous injection based on adjusted ideal body weight and administered in the evening (prior to the Plerixafor). The 1st dose on day -1 and every other day for 7 total doses. G-CSF administration of 7 every-other-day doses will be repeated every 28 days.
Other Names:Drug: Plerixafor
A fixed dose of 240 mcg/kg subcutaneous injection in the abdomen, calculated on ideal body weight. The 1st dose on day -1 and every other day for 7 total doses. Plerixafor administration of 7 every-other-day doses will be repeated every 28 days.
Other Name: MobozilDrug: Sorafenib
First dose will be given right after G-CSF and plerixafor injections. Drug doses will be separated by intervals of approximately 12 hours (+/-2 hours).
Dose Level 0 = 400 mg orally twice daily.
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|Contact: Michael Andreeff, MD, PhD||713-792-7260|
|United States, Texas|
|UT MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator: Michael Andreeff, MD, PhD|
|Principal Investigator:||Michael Andreeff, MD, PhD||M.D. Anderson Cancer Center|