Ignite Creation Date:
2024-05-05 @ 9:41 PM
Last Modification Date:
2024-10-26 @ 10:08 AM
Study NCT ID:
NCT00943943
Status:
COMPLETED
Last Update Posted:
2017-03-29
First Post:
2009-07-20
Brief Title:
Granulocyte-colony Stimulating Factor G-CSF and Plerixafor Plus Sorafenib for Acute Myelogenous Leukemia AML With FLT3 Mutations
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
G-CSF and Plerixafor With Sorafenib for Acute Myelogenous Leukemia With FLT3 Mutations
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical research study is to learn the most tolerable dose of Nexavarâ sorafenib when given in combination with Mobozilâ plerixafor and Neupogenâ filgrastim to patients with AML The safety of this combination will also be studied
Funding Source - FDA OOPD
Funding Source - FDA OOPD
Detailed Description:
The Study Drugs
Sorafenib is a type of drug called a multikinase inhibitor It is designed to interfere with the parts of cancer cells that are involved in the sending of chemical messages and helping the cells divide and grow which may block the formation of tumors and cause cell death
Filgrastim promotes the growth of white blood cells which help to fight infections
Plerixafor is designed to help move stem cells from the bone marrow to the blood
Study Drug Dose Level
If participant is found to be eligible to take part in this study they will be assigned to a dose level and schedule of sorafenib based on when they joined this study Up to 5 dose levels and schedules will be tested Three 3 participants will be enrolled at each dose level for Phase I of the study The first group of participants will receive dose level 0 of sorafenib If unacceptable side effects are seen a dose lower than level 0 will be tried If no side effects are seen the next group of 3 participants will be placed on a higher dose level called Level 1 Each new group will either receive a higher or lower dose of sorafenib or take it more or less often than the group before it based on whether intolerable side effects are seen This will continue until the best tolerable dose and schedule of sorafenib is found Once the best tolerable dose andor schedule is found the last 10 participants will be enrolled and will take sorafenib at that dose and schedule This last group of 10 is considered the early Phase II part of the study
Each group will receive the same dose level and schedule of filgrastim and plerixafor
Study Drug Administration
Participant will receive filgrastim and plerixafor by injection through a needle under the skin on Day 1 the day the study starts and then every other day for a total of 7 doses The injections will be given in the morning After day one the injections may be done at participants home Participants study doctor will meet with them one-on-one to discuss how the drug will be given
On Day 1 participant will begin taking their dose of sorafenib by mouth every other day once a day or twice a day depending on when they join the study
If participant is taking sorafenib every other day during Cycle 1 they will start taking it 12 hours after the filgrastim and plerixafor injections the next morning
If participant is taking sorafenib every day they will take it at the same time every morning The first time participant takes sorafenib during Cycle 1 will be 12 hours after the first filgrastim and plerixafor injections
If participant is taking sorafenib twice a day during Cycle 1 they will start taking it 12 hours after the filgrastim and plerixafor injections and then every 12 hours
Participant will take sorafenib without food at least 1 hour before or 2 hours after eating If participant misses a dose they should not take double the dose next time to make up for the missed dose
These 28 days are one study cycle
Participant is allowed to take hydroxyurea or other treatments to control high white blood cell counts
Study Drug Diary
Participant will be given a study drug diary that they will be expected to fill out whenever they take study drugs at home A staff member will explain to participant how to fill out the diary The study staff will review the diary with participant at every study visit and they will be given a new diary at the beginning of every cycle they start
Study Visits
Every week for the first 6 weeks and then every 4-8 weeks until participant leaves the study the following tests and procedures will be performed
Participant will have a physical exam including measurement of their weight and vital signs
Participant will have a bone marrow aspiration and biopsy done before treatment starts and once somewhere between day 14 and day 17 after the first Sorafenib administration Another bone marrow sample will be collected between days 24 and 28
If participant continues on study another bone marrow sample will be collected after the third cycle
Blood about 1 teaspoon will be drawn every 2-4 days for routine tests while participant is taking the study drugs and once a week on days they are not taking the study drugs Plerixafor and Neupogen
During the first week blood about 1 teaspoon will be drawn to check the status of the disease before each dose of the filgrastim and plerixafor combination and again 4 to 8 hours after receiving the study drugs If participants doctor feels it is needed additional blood may be drawn after the 2nd blood draw to check the status of the disease If participants doctor feels it is needed these blood draws may continue after the first week if the disease is not responding
Length of Study
Participant may continue taking the study drugs for up to 6 cycles about 6 months If participant is in complete remission partial remission or complete remission with incomplete platelet count recovery after 6 months with no intolerable side effects their doctor may discuss continuing on the study with them Participant will be taken off study if the disease gets worse or intolerable side effects occur
Follow-up Visits
If participant is in complete remission and if their doctor thinks it is in their best interest they may have follow-up visits about every 3 months until the study closes
Blood about 2 teaspoons will be drawn for routine tests
Participant will have a bone marrow biopsy andor aspirate to check the status of the disease
End-of-Study Visit
Participant will have an end-of-study visit about 30 days after their last dose of the study drugs At this visit the following tests and procedures will be performed
Participant will have a physical exam including measurement of their weight and vital signs
Blood about 2 tablespoons will be drawn for routine tests
Participant will have a bone marrow aspirate and biopsy to check the status of the disease
This is an investigational study Sorafenib is FDA-approved and commercially available for treatment of advanced renal cell cancer RCC and hepatocellular cancer HCC that cannot be removed by surgery Its use in patients with AML is investigational
Plerixafor is FDA-approved and commercially available for use in boosting the number of hematopoietic stem cells HSC for stem cell collection and transplants in combination with filgrastim in participants with non-Hodgkins lymphoma NHL and multiple myeloma MM Its use in participants with AML is investigational
Filgrastim NeupogenÒ is FDA-approved and commercially available for use in boosting white blood cell production in participants with low blood cell counts caused by chemotherapy nonmyeloid malignancies acute myeloid leukemia and bone marrow transplantation treating severe chronic neutropenia SCN-low blood counts and boosting production of hematopoietic progenitor cells in patients undergoing peripheral blood progenitor cell PBPC collection
Up to 28 participants will take part in this study All will be enrolled at MD Anderson
Sorafenib is a type of drug called a multikinase inhibitor It is designed to interfere with the parts of cancer cells that are involved in the sending of chemical messages and helping the cells divide and grow which may block the formation of tumors and cause cell death
Filgrastim promotes the growth of white blood cells which help to fight infections
Plerixafor is designed to help move stem cells from the bone marrow to the blood
Study Drug Dose Level
If participant is found to be eligible to take part in this study they will be assigned to a dose level and schedule of sorafenib based on when they joined this study Up to 5 dose levels and schedules will be tested Three 3 participants will be enrolled at each dose level for Phase I of the study The first group of participants will receive dose level 0 of sorafenib If unacceptable side effects are seen a dose lower than level 0 will be tried If no side effects are seen the next group of 3 participants will be placed on a higher dose level called Level 1 Each new group will either receive a higher or lower dose of sorafenib or take it more or less often than the group before it based on whether intolerable side effects are seen This will continue until the best tolerable dose and schedule of sorafenib is found Once the best tolerable dose andor schedule is found the last 10 participants will be enrolled and will take sorafenib at that dose and schedule This last group of 10 is considered the early Phase II part of the study
Each group will receive the same dose level and schedule of filgrastim and plerixafor
Study Drug Administration
Participant will receive filgrastim and plerixafor by injection through a needle under the skin on Day 1 the day the study starts and then every other day for a total of 7 doses The injections will be given in the morning After day one the injections may be done at participants home Participants study doctor will meet with them one-on-one to discuss how the drug will be given
On Day 1 participant will begin taking their dose of sorafenib by mouth every other day once a day or twice a day depending on when they join the study
If participant is taking sorafenib every other day during Cycle 1 they will start taking it 12 hours after the filgrastim and plerixafor injections the next morning
If participant is taking sorafenib every day they will take it at the same time every morning The first time participant takes sorafenib during Cycle 1 will be 12 hours after the first filgrastim and plerixafor injections
If participant is taking sorafenib twice a day during Cycle 1 they will start taking it 12 hours after the filgrastim and plerixafor injections and then every 12 hours
Participant will take sorafenib without food at least 1 hour before or 2 hours after eating If participant misses a dose they should not take double the dose next time to make up for the missed dose
These 28 days are one study cycle
Participant is allowed to take hydroxyurea or other treatments to control high white blood cell counts
Study Drug Diary
Participant will be given a study drug diary that they will be expected to fill out whenever they take study drugs at home A staff member will explain to participant how to fill out the diary The study staff will review the diary with participant at every study visit and they will be given a new diary at the beginning of every cycle they start
Study Visits
Every week for the first 6 weeks and then every 4-8 weeks until participant leaves the study the following tests and procedures will be performed
Participant will have a physical exam including measurement of their weight and vital signs
Participant will have a bone marrow aspiration and biopsy done before treatment starts and once somewhere between day 14 and day 17 after the first Sorafenib administration Another bone marrow sample will be collected between days 24 and 28
If participant continues on study another bone marrow sample will be collected after the third cycle
Blood about 1 teaspoon will be drawn every 2-4 days for routine tests while participant is taking the study drugs and once a week on days they are not taking the study drugs Plerixafor and Neupogen
During the first week blood about 1 teaspoon will be drawn to check the status of the disease before each dose of the filgrastim and plerixafor combination and again 4 to 8 hours after receiving the study drugs If participants doctor feels it is needed additional blood may be drawn after the 2nd blood draw to check the status of the disease If participants doctor feels it is needed these blood draws may continue after the first week if the disease is not responding
Length of Study
Participant may continue taking the study drugs for up to 6 cycles about 6 months If participant is in complete remission partial remission or complete remission with incomplete platelet count recovery after 6 months with no intolerable side effects their doctor may discuss continuing on the study with them Participant will be taken off study if the disease gets worse or intolerable side effects occur
Follow-up Visits
If participant is in complete remission and if their doctor thinks it is in their best interest they may have follow-up visits about every 3 months until the study closes
Blood about 2 teaspoons will be drawn for routine tests
Participant will have a bone marrow biopsy andor aspirate to check the status of the disease
End-of-Study Visit
Participant will have an end-of-study visit about 30 days after their last dose of the study drugs At this visit the following tests and procedures will be performed
Participant will have a physical exam including measurement of their weight and vital signs
Blood about 2 tablespoons will be drawn for routine tests
Participant will have a bone marrow aspirate and biopsy to check the status of the disease
This is an investigational study Sorafenib is FDA-approved and commercially available for treatment of advanced renal cell cancer RCC and hepatocellular cancer HCC that cannot be removed by surgery Its use in patients with AML is investigational
Plerixafor is FDA-approved and commercially available for use in boosting the number of hematopoietic stem cells HSC for stem cell collection and transplants in combination with filgrastim in participants with non-Hodgkins lymphoma NHL and multiple myeloma MM Its use in participants with AML is investigational
Filgrastim NeupogenÒ is FDA-approved and commercially available for use in boosting white blood cell production in participants with low blood cell counts caused by chemotherapy nonmyeloid malignancies acute myeloid leukemia and bone marrow transplantation treating severe chronic neutropenia SCN-low blood counts and boosting production of hematopoietic progenitor cells in patients undergoing peripheral blood progenitor cell PBPC collection
Up to 28 participants will take part in this study All will be enrolled at MD Anderson
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2009-01512 | REGISTRY | NCI CTRP | httpsreporternihgovquickSearchR21CA143805 |
| R01FD003733 | FDA | None | None |
| R21CA143805 | NIH | None | None |