Advanced CancersPhase 1NCT01200004
Study of Grifola Frondosa (Maitake), Azacitidine, and Lenalidomide
A Phase 1 study testing Azacitidine, Lenalidomide and Grifola Frondosa in people with Advanced Cancers, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Advanced Cancers
- What is being tested?
- Azacitidine, Lenalidomide and Grifola Frondosa
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Jul 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study of Epigenetic Immunomodulation Through the Use of Azacitidine, Lenalidomide, and Grifola Frondosa in Patients With Advanced Malignancy
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.
Read the detailed description
Study Drugs:
Azacitidine is designed to block certain proteins in cancer cells whose job is to stop the function of the tumor-fighting proteins. By blocking the "bad" proteins, the tumor-fighting genes may be able to work better.
Lenalidomide is designed to change the body's immune system. It may also interfere with the development of tiny blood vessels that help support tumor growth. This may decrease the growth of cancer cells.
Grifola frondosa extract is a natural substance taken from maitake mushrooms. Researchers want to learn if it can cause the body's immune system to react against cancer.
Study Groups:
If you are found to be eligible to take part in this study, you will be assigned to receive either azacitidine and lenalidomide, azacitidine and Grifola frondosa, or azacitidine, lenalidomide, and Grifola frondosa at a dose level based on when you joined this study.
Up to 4 dose levels of azacitidine and lenalidomide will be tested. Up to 2 dose levels of azacitidine and Grifola frondosa will be tested. At the beginning of the study, 3-6 participants will be enrolled at each dose level of the study drug combinations. The first group of participants will receive the lowest dose level of azacitidine and lenalidomide. Each new group will receive a higher dose of the study drug combination than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of the study drug combination is found. After enrollment in the azacitidine and lenalidomide group is completed, the next group of participants will receive the lowest dose level of azacitidine and Grifola frondosa. Each new group will receive a higher dose of the study drug combination than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of the study drug combination is found.
After the highest dose of the azacitidine and lenalidomide or Grifola frondosa combinations are found, new participants enrolling in this study will begin receiving Grifola frondosa along with azacitidine and lenalidomide. Up to 2 dose levels will be tested. The first group of participants will receive the lowest dose level of lenalidomide. The next group will receive a higher dose of lenalidomide than the group before it, if no intolerable side effects were seen. The doses of azacitidine and Grifola frondosa will stay the same.
The dose of the study drug combination that you receive may be lowered if you have any intolerable side effects.
Study Drug Administration:
A study drug "cycle" is 28 days.
On Days 1-5 of each Cycle, you will receive azacitidine either under the skin or by vein. If you receive azacitidine as an injection under the skin, you will receive it over 10 minutes. If you receive azacitidine by vein, you will receive it over 40 minutes.
On Day 2 of Cycle 1, you will begin taking lenalidomide 1 time each day until Day 21, then you will have a 7 day-rest period. For Cycle 2 and every cycle after that, you will take lenalidomide 1 time each day on Days 1-21 followed by a 7-day rest period. Lenalidomide is a capsule that you will take by mouth with water. The capsules should be swallowed whole. You should not break, chew, or open the capsules.
If you are assigned to receive Grifola frondosa, you will also begin taking Grifola frondosa 2 times each day on Day 2 of Cycle 1 if you are also taking azacitidine. If you are also taking azacitidine and lenalidomide, you will begin taking Grifola frondosa on Day 3 of Cycle 1. Depending on the dose level you are assigned to, you will either take Grifola frondosa 2 times each day until Day 21 followed by a 7-day rest period, or you will take Grifola frondosa 2 times daily during all cycles. Grifola frondosa is a liquid extract that comes in a glass bottle. Your dose of Grifola frondosa will be based on when you joined the study and your body weight.
Expansion Groups:
After the highest tolerable dose of each study drug combination is found, 42 additional participants will be enrolled in 3 expansion groups (14 in each group), one group for each study drug combination at the highest tolerable dose or a dose level that has been shown to be safe.
Study Visits:
The following tests and procedures will be performed within 7 days before your first dose of study drug:
- You will have a physical exam, including measurement of your weight and vital signs.
- Your performance status will be recorded.
- Blood (about 2 teaspoons) and urine will be collected for routine tests.
Women who are able to have children must have a negative blood (about 1 teaspoon) pregnancy test within 10 to 14 days before the first dose of the study drug combination and again within 24 hours before receiving lenalidomide.
Before you begin each cycle, the following tests and procedures will be performed:
- You will have a physical exam, including measurement of your weight and vital signs.
- Your performance status will be recorded.
- Blood (about 2 teaspoons) and urine will be collected for routine tests.
- You will be asked about any side effects you may be having.
- If the study doctor thinks it is needed, blood (about 1 teaspoon) will be drawn to measure tumor markers.
- Women who are able to have children will have a blood pregnancy test.
Every week during Cycles 1 and 2, blood (about 2 teaspoons) will be drawn for routine tests.
Women who are able to have children will have a blood (about 1 teaspoon) pregnancy test every week during Cycle 1.
At the end of every 2 cycles (Cycles 2, 4, 6, and so on), you will have a CT, MRI, PET scan, and/or x-ray to check the status of the disease.
If you are in the one of the Expansion Groups, blood (about 6 teaspoons each time) will be drawn for biomarker testing before you take the first dose of study drug, on Days 21 and 28 of Cycle 1, 1 time during each cycle after that, and at the end-of-study visit.
Length of Study:
You may continue taking the study drugs for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drugs if the disease gets worse or intolerable side effects occur.
End-of-Study Visit:
Within 30 days after your last dose of the study drug combination, you will have an end-of-study visit. The following tests and procedures performed:
- You will have a physical exam, including measurement of your weight and vital signs.
- Your performance status will be recorded.
- Blood (about 2 teaspoons) and urine will be collected for routine tests.
- You will be asked about any side effects you may be having.
- If the study doctor thinks it is needed, blood (about 1 teaspoon) will be drawn to measure tumor markers.
- If the study doctor thinks it is needed, you will have a chest x-ray, CT, MRI, and/or PET scan to check the status of the disease.
- Women who are able to have children will have a blood pregnancy test.
This is an investigational study. Grifola frondosa extract is not FDA approved for any usage. Its use in this study is investigational. Azacitidine and lenalidomide are FDA approved and commercially available for the treatment of multiple myeloma and myelodysplastic syndrome. The use of the study drug combination (Grifola frondosa, azacitidine, and lenalidomide) is currently being used for research purposes only.
Up to 102 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Advanced Cancers
- Being tested
- Azacitidine, Lenalidomide, Grifola Frondosa
- Keywords
- Advanced solid tumor, Azacitidine, Grifola frondosa, Basidiomycete fungus, Lenalidomide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzacitidineDrug
Also called 5-Azacytidine, 5-aza, Vidaza, 5-AZC
75 mg/m2 subcutaneous or by vein on days 1 - 5 of a 28 day cycle.
LenalidomideDrug
Also called CC-5013, Revlimid
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.
Grifola FrondosaDrug
3 mg/kg by mouth twice a day on days 1 - 21 of a 28 day cycle.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Azacitidine; Drug: Lenalidomide; Drug: Grifola Frondosa |
| Expansion Group A | Experimental | Azacitidine + Lenalidomide MTD, then 2 weeks later Grifola frondosa Receives: Drug: Lenalidomide |
| Expansion Group B | Experimental | Azacitidine + Grifola Frondosa, then 2 weeks later Lenalidomide Receives: Drug: Lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD)
MTD defined by patient dose limiting toxicities (DLTs) that occur in the first cycle (4 weeks).
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2010 (estimated)
- Study startApr 2012
- Primary completionJul 2013
- Study completionJul 2013
Why it stopped: Slow Accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancersStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Yukiguni Maitake Company Ltd.
- Responsible party
- Sponsor
- Investigators
- Siqing Fu, MD, PHD, Principal investigator, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01200004
- Sponsor's protocol ID
- 2010-0076
- Status last verified
- Jul 2013
- First submitted
- 9 Sep 2010
- Last updated
- 2 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Epigenetic Immunomodulation Through the Use of Azacitidine, Lenalidomide, and Grifola Frondosa in Patients With Advanced Malignancy
- ClinicalTrials.gov ID
- NCT01200004
- Acronym / sponsor ID
- 2010-0076
- Conditions
- Advanced Cancers
- Keywords
- Advanced solid tumor, Azacitidine, Grifola frondosa, Basidiomycete fungus, Lenalidomide
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow Accrual.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Yukiguni Maitake Company Ltd.
- Study start
- Apr 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 13 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Drugs:
Azacitidine is designed to block certain proteins in cancer cells whose job is to stop the function of the tumor-fighting proteins. By blocking the "bad" proteins, the tumor-fighting genes may be able to work better.
Lenalidomide is designed to change the body's immune system. It may also interfere with the development of tiny blood vessels that help support tumor growth. This may decrease the growth of cancer cells.
Grifola frondosa extract is a natural substance taken from maitake mushrooms. Researchers want to learn if it can cause the body's immune system to react against cancer.
Study Groups:
If you are found to be eligible to take part in this study, you will be assigned to receive either azacitidine and lenalidomide, azacitidine and Grifola frondosa, or azacitidine, lenalidomide, and Grifola frondosa at a dose level based on when you joined this study.
Up to 4 dose levels of azacitidine and lenalidomide will be tested. Up to 2 dose levels of azacitidine and Grifola frondosa will be tested. At the beginning of the study, 3-6 participants will be enrolled at each dose level of the study drug combinations. The first group of participants will receive the lowest dose level of azacitidine and lenalidomide. Each new group will receive a higher dose of the study drug combination than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of the study drug combination is found. After enrollment in the azacitidine and lenalidomide group is completed, the next group of participants will receive the lowest dose level of azacitidine and Grifola frondosa. Each new group will receive a higher dose of the study drug combination than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of the study drug combination is found.
After the highest dose of the azacitidine and lenalidomide or Grifola frondosa combinations are found, new participants enrolling in this study will begin receiving Grifola frondosa along with azacitidine and lenalidomide. Up to 2 dose levels will be tested. The first group of participants will receive the lowest dose level of lenalidomide. The next group will receive a higher dose of lenalidomide than the group before it, if no intolerable side effects were seen. The doses of azacitidine and Grifola frondosa will stay the same.
The dose of the study drug combination that you receive may be lowered if you have any intolerable side effects.
Study Drug Administration:
A study drug "cycle" is 28 days.
On Days 1-5 of each Cycle, you will receive azacitidine either under the skin or by vein. If you receive azacitidine as an injection under the skin, you will receive it over 10 minutes. If you receive azacitidine by vein, you will receive it over 40 minutes.
On Day 2 of Cycle 1, you will begin taking lenalidomide 1 time each day until Day 21, then you will have a 7 day-rest period. For Cycle 2 and every cycle after that, you will take lenalidomide 1 time each day on Days 1-21 followed by a 7-day rest period. Lenalidomide is a capsule that you will take by mouth with water. The capsules should be swallowed whole. You should not break, chew, or open the capsules.
If you are assigned to receive Grifola frondosa, you will also begin taking Grifola frondosa 2 times each day on Day 2 of Cycle 1 if you are also taking azacitidine. If you are also taking azacitidine and lenalidomide, you will begin taking Grifola frondosa on Day 3 of Cycle 1. Depending on the dose level you are assigned to, you will either take Grifola frondosa 2 times each day until Day 21 followed by a 7-day rest period, or you will take Grifola frondosa 2 times daily during all cycles. Grifola frondosa is a liquid extract that comes in a glass bottle. Your dose of Grifola frondosa will be based on when you joined the study and your body weight.
Expansion Groups:
After the highest tolerable dose of each study drug combination is found, 42 additional participants will be enrolled in 3 expansion groups (14 in each group), one group for each study drug combination at the highest tolerable dose or a dose level that has been shown to be safe.
Study Visits:
The following tests and procedures will be performed within 7 days before your first dose of study drug:
- You will have a physical exam, including measurement of your weight and vital signs.
- Your performance status will be recorded.
- Blood (about 2 teaspoons) and urine will be collected for routine tests.
Women who are able to have children must have a negative blood (about 1 teaspoon) pregnancy test within 10 to 14 days before the first dose of the study drug combination and again within 24 hours before receiving lenalidomide.
Before you begin each cycle, the following tests and procedures will be performed:
- You will have a physical exam, including measurement of your weight and vital signs.
- Your performance status will be recorded.
- Blood (about 2 teaspoons) and urine will be collected for routine tests.
- You will be asked about any side effects you may be having.
- If the study doctor thinks it is needed, blood (about 1 teaspoon) will be drawn to measure tumor markers.
- Women who are able to have children will have a blood pregnancy test.
Every week during Cycles 1 and 2, blood (about 2 teaspoons) will be drawn for routine tests.
Women who are able to have children will have a blood (about 1 teaspoon) pregnancy test every week during Cycle 1.
At the end of every 2 cycles (Cycles 2, 4, 6, and so on), you will have a CT, MRI, PET scan, and/or x-ray to check the status of the disease.
If you are in the one of the Expansion Groups, blood (about 6 teaspoons each time) will be drawn for biomarker testing before you take the first dose of study drug, on Days 21 and 28 of Cycle 1, 1 time during each cycle after that, and at the end-of-study visit.
Length of Study:
You may continue taking the study drugs for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drugs if the disease gets worse or intolerable side effects occur.
End-of-Study Visit:
Within 30 days after your last dose of the study drug combination, you will have an end-of-study visit. The following tests and procedures performed:
- You will have a physical exam, including measurement of your weight and vital signs.
- Your performance status will be recorded.
- Blood (about 2 teaspoons) and urine will be collected for routine tests.
- You will be asked about any side effects you may be having.
- If the study doctor thinks it is needed, blood (about 1 teaspoon) will be drawn to measure tumor markers.
- If the study doctor thinks it is needed, you will have a chest x-ray, CT, MRI, and/or PET scan to check the status of the disease.
- Women who are able to have children will have a blood pregnancy test.
This is an investigational study. Grifola frondosa extract is not FDA approved for any usage. Its use in this study is investigational. Azacitidine and lenalidomide are FDA approved and commercially available for the treatment of multiple myeloma and myelodysplastic syndrome. The use of the study drug combination (Grifola frondosa, azacitidine, and lenalidomide) is currently being used for research purposes only.
Up to 102 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Azacitidine + Lenalidomide | Experimental | Drug: Azacitidine, Drug: LenalidomideAzacitidine 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. |
| Azacitidine + Lenalidomide + Grifola Frondosa | Experimental | Drug: Azacitidine, Drug: Lenalidomide, Drug: Grifola FrondosaOnce 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. |
| Expansion Group A | Experimental | Drug: LenalidomideAzacitidine + Lenalidomide MTD, then 2 weeks later Grifola frondosa |
| Expansion Group B | Experimental | Drug: LenalidomideAzacitidine + Grifola Frondosa, then 2 weeks later Lenalidomide |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AzacitidineAlso: 5-Azacytidine, 5-aza, Vidaza, 5-AZC75 mg/m2 subcutaneous or by vein on days 1 - 5 of a 28 day cycle. | Drug | Azacitidine + Lenalidomide, Azacitidine + Lenalidomide + Grifola Frondosa |
| LenalidomideAlso: CC-5013, RevlimidStarting 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 + Lenalidomide, Azacitidine + Lenalidomide + Grifola Frondosa, Expansion Group A, Expansion Group B |
| Grifola Frondosa3 mg/kg by mouth twice a day on days 1 - 21 of a 28 day cycle. | Drug | Azacitidine + Lenalidomide + Grifola Frondosa |
Primary outcome
Maximum Tolerated Dose (MTD)
Time frame: 4 weeks
MTD defined by patient dose limiting toxicities (DLTs) that occur in the first cycle (4 weeks).
Results and safety
The study was stopped early (reason given: Slow Accrual.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2013.
- UT MD Anderson Cancer Center websiteLink provided by the sponsor.
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Carcinoma, Renal Cell
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Siqing Fu, MD, PHD principal investigator
UT MD Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Azacitidine, Lenalidomide and Grifola Frondosa in people with Advanced Cancers, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Slow Accrual.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2013.