Study of Grifola Frondosa (Maitake), Azacitidine, and Lenalidomide

NCT01200004 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2013-08-02

No results posted yet for this study

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

Azacitidine

75 mg/m2 subcutaneous or by vein on days 1 - 5 of a 28 day cycle.

DRUG

Lenalidomide

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01200004 on ClinicalTrials.gov