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

NCT01200004 | Terminated Phase 1

• 1 other identifier: 2010-0076
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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

Advanced Cancers

Keywords

Advanced solid tumor; Azacitidine; Grifola frondosa; Basidiomycete fungus; Lenalidomide

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose (MTD)

  MTD defined by patient dose limiting toxicities (DLTs) that occur in the first cycle (4 weeks).

  4 weeks

Study Arms (4)

Azacitidine + Lenalidomide

EXPERIMENTAL

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; Drug: Lenalidomide

Azacitidine + Lenalidomide + Grifola Frondosa

EXPERIMENTAL

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; Drug: Lenalidomide; Drug: Grifola Frondosa

Expansion Group A

EXPERIMENTAL

Azacitidine + Lenalidomide MTD, then 2 weeks later Grifola frondosa

Drug: Lenalidomide

Expansion Group B

EXPERIMENTAL

Azacitidine + Grifola Frondosa, then 2 weeks later Lenalidomide

Drug: Lenalidomide

Interventions

Azacitidine DRUG

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

Also known as: 5-Azacytidine, 5-aza, Vidaza, 5-AZC, AZA-CR, Ladakamycin, NSC-102816

Azacitidine + Lenalidomide; Azacitidine + Lenalidomide + Grifola Frondosa

Lenalidomide 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.

Also known as: CC-5013, Revlimid

Azacitidine + Lenalidomide; Azacitidine + Lenalidomide + Grifola Frondosa; Expansion Group A; Expansion Group B

Grifola Frondosa DRUG

3 mg/kg by mouth twice a day on days 1 - 21 of a 28 day cycle.

Azacitidine + Lenalidomide + Grifola Frondosa

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patients must have ECOG performance status 2 or better (0-2).
• 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
• Patients must be able to understand and be willing to sign an IRB-approved written informed consent document.
• 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).
• 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.
• Life expectancy greater than 3 months based on the attending physician's discretion.
• All study participants must be registered in the mandatory RevAssist program, and be willing and able to comply with the requirements of RevAssist.

You may not qualify if:

• 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.
• 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.
• History of allergic reactions to the study drugs or their analogs.
• 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
• Concurrent known immunosuppressors.
• Inability to swallow oral medication.
• Pregnant or breastfeeding women.
• Concurrent enrollment on another research study.
• Known hepatitis B and C infection, HIV infection and autoimmune disorders.
• Subjects with known moderate or severe renal impairment will be excluded if creatinine clearance \< 60 ml/min.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Yukiguni Maitake Company Ltd.: collaborator

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center website

MeSH Terms

Interventions

Azacitidine; Lenalidomide

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Piperidones; Piperidines; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Siqing Fu, MD, PHD

  UT MD Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2010
• First Posted: September 13, 2010
• Study Start: April 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: August 2, 2013

Record last verified: 2013-07

Locations

US (1)