Clinical trial · Interventional
Study of Grifola Frondosa (Maitake), Azacitidine, and Lenalidomide
A Phase I Study of Epigenetic Immunomodulation Through the Use of Azacitidine, Lenalidomide, and Grifola Frondosa in Patients With Advanced Malignancy
NCT01200004CI-TRIAL-00011550terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow Accrual.
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancers | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Azacitidine | Drug | Azacitidine | ALIAS |
| Grifola Frondosa | Drug | — | UNRESOLVED |
| Lenalidomide | Drug | Lenalidomide | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Azacitidine + Lenalidomide
- description
- 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.
- interventionNames
- Drug: Azacitidine
- Drug: Lenalidomide
- type
- EXPERIMENTAL
- label
- Azacitidine + Lenalidomide + Grifola Frondosa
- description
- 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.
- interventionNames
- Drug: Azacitidine
- Drug: Lenalidomide
- Drug: Grifola Frondosa
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 13 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.