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

This study has been terminated.
(Slow Accrual.)
Sponsor:
Collaborator:
Yukiguni Maitake Company Ltd.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01200004
First received: September 9, 2010
Last updated: July 31, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Advanced Cancers
Drug: Azacitidine
Drug: Lenalidomide
Drug: Grifola Frondosa
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of Epigenetic Immunomodulation Through the Use of Azacitidine, Lenalidomide, and Grifola Frondosa in Patients With Advanced Malignancy

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Maximum Tolerated Dose (MTD) [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    MTD defined by patient dose limiting toxicities (DLTs) that occur in the first cycle (4 weeks).


Enrollment: 1
Study Start Date: April 2012
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Azacitidine + Lenalidomide
Azacitidine 75 mg/m2 subcutaneous or by vein on days 1 - 5 of a 28 day cycle. 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: Azacitidine
75 mg/m2 subcutaneous or by vein on days 1 - 5 of a 28 day cycle.
Other Names:
  • 5-Azacytidine
  • 5-aza
  • Vidaza
  • 5-AZC
  • AZA-CR
  • Ladakamycin
  • NSC-102816
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.
Other Names:
  • CC-5013
  • Revlimid
Experimental: Azacitidine + Lenalidomide + Grifola Frondosa
Once Lenalidomide MTD identified in combination with azacitidine, Grifola frondosa added. Cycle 1, azacitidine on day 1, lenalidomide on day 2 and Grifola frondosa on day 3. Azacitidine daily for 5 days every 28 days while lenalidomide and Grifola frondosa on days 1-21 of subsequent cycles.
Drug: Azacitidine
75 mg/m2 subcutaneous or by vein on days 1 - 5 of a 28 day cycle.
Other Names:
  • 5-Azacytidine
  • 5-aza
  • Vidaza
  • 5-AZC
  • AZA-CR
  • Ladakamycin
  • NSC-102816
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.
Other Names:
  • CC-5013
  • Revlimid
Drug: Grifola Frondosa
3 mg/kg by mouth twice a day on days 1 - 21 of a 28 day cycle.
Experimental: Expansion Group A
Azacitidine + Lenalidomide MTD, then 2 weeks later Grifola frondosa
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.
Other Names:
  • CC-5013
  • Revlimid
Experimental: Expansion Group B
Azacitidine + Grifola Frondosa, then 2 weeks later Lenalidomide
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.
Other Names:
  • CC-5013
  • Revlimid

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients must have histologically or cytologically confirmed diagnosis of an advanced solid tumor refractory to standard treatment or for which no standard therapy is available.
  2. Patients must have ECOG performance status 2 or better (0-2).
  3. Patients must have normal organ and marrow function as defined: Absolute lymphocyte count > 1,000 /uL, Absolute neutrophil count > 1,500 /uL, Platelets > 75,000 /uL, Bilirubin </= 1.5 * ULN and AST and/or ALT </= 2.5 * the institutional upper limit of normal (ULN), </= 5 * ULN for patients with liver metastases, Serum creatinine within normal limits; if abnormal, then a calculated creatinine clearance >/= 50 mL/min
  4. Patients must be able to understand and be willing to sign an IRB-approved written informed consent document.
  5. Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mlU/mL within 10-14 days prior to and again within 24 hours of prescribing lenalidomide (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide.FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. A female of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (ie, has had menses at any time in the preceding 24 consecutive months).
  6. Patients must be 18 years of age or older since the safety and dosages of these study drugs has not been demonstrated in the pediatric population. Exception: patients who are 13 years old or older and have more than 50 kg of body weight will be eligible after consultation with their pediatric attending.
  7. Life expectancy greater than 3 months based on the attending physician's discretion.
  8. All study participants must be registered in the mandatory RevAssist program, and be willing and able to comply with the requirements of RevAssist.

Exclusion Criteria:

  1. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (NYHA Class III or IV), unstable angina pectoris, symptomatic cardiac arrhythmia, active bleeding, active thrombosis, or psychiatric illness/social situations that would limit compliance with study requirements.
  2. History of stroke or transient ischemic attack within 6 months prior to study enrollment and significant vascular disease (e.g., aortic aneurysm, aortic dissection) and symptomatic peripheral vascular disease.
  3. History of allergic reactions to the study drugs or their analogs.
  4. Patients that have had any treatment specific for tumor control within 3 weeks of study drug treatment or: a. within 2 weeks if cytotoxic agents were given weekly b. within 6 weeks for nitrosoureas or mitomycin C c. within 4 half-lives for targeted agents with half lives and pharmacodynamic effects lasting less than 5 days (that includes, but is not limited to, erlotinib, sorafenib, sunitinib, bortezomib, and other similar agents) d. failed to recover from toxic effects of any therapy prior to study entry
  5. Concurrent known immunosuppressors.
  6. Inability to swallow oral medication.
  7. Pregnant or breastfeeding women.
  8. Concurrent enrollment on another research study.
  9. Known hepatitis B and C infection, HIV infection and autoimmune disorders.
  10. Subjects with known moderate or severe renal impairment will be excluded if creatinine clearance < 60 ml/min.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01200004

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Yukiguni Maitake Company Ltd.
Investigators
Principal Investigator: Siqing Fu, MD, PHD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01200004     History of Changes
Other Study ID Numbers: 2010-0076
Study First Received: September 9, 2010
Last Updated: July 31, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Advanced solid tumor
Azacitidine
Grifola frondosa
Basidiomycete fungus
Lenalidomide

Additional relevant MeSH terms:
Neoplasms
Azacitidine
Lenalidomide
Thalidomide
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on April 17, 2014