Study of Grifola Frondosa (Maitake), Azacitidine, and Lenalidomide
NCT01200004 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 1
Last updated 2013-08-02
Summary
The goal of this clinical research study is to find the highest tolerable dose of the combination of Grifola frondosa extract, azacitidine, and lenalidomide that can be given to patients with advanced cancer. The safety of this drug combination will also be studied.
Conditions
Interventions
- DRUG
-
75 mg/m2 subcutaneous or by vein on days 1 - 5 of a 28 day cycle.
- DRUG
-
Starting dose 10 mg by mouth daily on days 1-21 of a 28 day cycle, until maximum tolerated dose (MTD) reached. MTD used for combination and expansion groups.
- DRUG
-
Grifola Frondosa
3 mg/kg by mouth twice a day on days 1 - 21 of a 28 day cycle.
Sponsors & Collaborators
-
Yukiguni Maitake Company Ltd.
collaborator UNKNOWN -
M.D. Anderson Cancer Center
lead OTHER
Principal Investigators
-
Siqing Fu, MD, PHD · UT MD Anderson Cancer Center
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 13 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-04-30
- Primary Completion
- 2013-07-31
- Completion
- 2013-07-31
Countries
- United States
Study Locations
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