Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00030992
Status:
COMPLETED
Last Update Posted:
2012-08-20
First Post:
2002-02-20
Brief Title:
BMS 247550 to Treat Kidney Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Phase II Clinical Trial of BMS-247550 NSC 710428 an Epothilone B Analog in Renal Cell Carcinoma
Status:
COMPLETED
Status Verified Date:
2012-06
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:
This study will examine whether the experimental drug BMS 247550 Ixabepilone is an effective treatment for kidney cancer BMS 247550 belongs to a class of drugs called epothilones that interfere with the ability of cancer cells to divide In the way they kill cells they are very similar to a class of compounds known as the taxanes which include the drug Taxol Other characteristics of the epothilones however enable them to work in cells that are resistant to Taxol
Patients 18 years of age or older with kidney cancer that has not spread to the central nervous system unless the brain tumor has remained stable for at least six months after surgical or radiation treatment may be eligible for this study Pregnant or nursing women may not participate Candidates are screened with various tests that may include blood and urine tests electrocardiogram EKG and chest x-ray Computerized tomography CT scans or X-rays and possibly nuclear medicine studies may be done to determine the extent of disease
Participants receive BMS 247550 by a 1-hour infusion into a vein for 5 consecutive days days 1 2 3 4 and 5 of each 21-day treatment cycle Patients must stay in the National Institutes of Health NIH area near Bethesda Maryland for 7 to 8 days during the first treatment cycle and for the 5 days of treatment in subsequent cycles The total number of cycles will vary among patients depending on their individual clinical situation The drug dose may be increased gradually in subsequent cycles in patients who can tolerate such increases In addition participants undergo the following tests and procedures
Periodic physical examinations and frequent blood tests
X-ray and other imaging studies to determine if the tumor is responding to the treatment
Tumor biopsies to confirm the diagnosis or spread of tumor and to examine the reaction of certain proteins in cancer cells to BMS 247550 Two biopsies will be done For this procedure a small piece of tumor tissue is withdrawn through a needle under local anesthetic
Treatment will be stopped in patients whose tumor grows while receiving BMS 247550 Patients whose tumor disappears completely will be followed at NIH periodically for examinations and tests Patients whose disease does not completely resolve or whose disease recurs may be advised of other appropriate research protocols at NIH or if none are available will be returned to the care of their local doctor
Patients 18 years of age or older with kidney cancer that has not spread to the central nervous system unless the brain tumor has remained stable for at least six months after surgical or radiation treatment may be eligible for this study Pregnant or nursing women may not participate Candidates are screened with various tests that may include blood and urine tests electrocardiogram EKG and chest x-ray Computerized tomography CT scans or X-rays and possibly nuclear medicine studies may be done to determine the extent of disease
Participants receive BMS 247550 by a 1-hour infusion into a vein for 5 consecutive days days 1 2 3 4 and 5 of each 21-day treatment cycle Patients must stay in the National Institutes of Health NIH area near Bethesda Maryland for 7 to 8 days during the first treatment cycle and for the 5 days of treatment in subsequent cycles The total number of cycles will vary among patients depending on their individual clinical situation The drug dose may be increased gradually in subsequent cycles in patients who can tolerate such increases In addition participants undergo the following tests and procedures
Periodic physical examinations and frequent blood tests
X-ray and other imaging studies to determine if the tumor is responding to the treatment
Tumor biopsies to confirm the diagnosis or spread of tumor and to examine the reaction of certain proteins in cancer cells to BMS 247550 Two biopsies will be done For this procedure a small piece of tumor tissue is withdrawn through a needle under local anesthetic
Treatment will be stopped in patients whose tumor grows while receiving BMS 247550 Patients whose tumor disappears completely will be followed at NIH periodically for examinations and tests Patients whose disease does not completely resolve or whose disease recurs may be advised of other appropriate research protocols at NIH or if none are available will be returned to the care of their local doctor
Detailed Description:
Background
BMS-247550 NSC 710428 ixabepilone is a semi-synthetic analog of the natural product epothilone B
The epothilones are a novel class of non-taxane microtubule-stabilizing agents obtained from the fermentation of the cellulose degrading myxobacteria Sorangium cellulosum
BMS-247550 is active against cancer models that are naturally insensitive to paclitaxel or have developed resistance to paclitaxel both in-vitro and in-vivo
Objectives
Establish the efficacy of the investigational agent BMS-247550 in patients with renal cell carcinoma when administered as a one hour infusion on day 1 to 5 every 21 days
Evaluate the plasma pharmacokinetics of BMS-247550
Explore the pharmacodynamics of BMS-247550 using an assay that measures the amount of endogenous tubulin in peripheral blood mononuclear cells PBMC that exists in the polymerized versus the unpolymerized state
Determine the extent to which pharmacodynamic changes are observed over a range of doses of BMS-247550
Determine if cross-resistance to BMS-247550 exists in patients who have previously received sorafenib or sunitinib
Eligibility
Age greater than 18
Pathological confirmation of renal cell carcinoma
Prior chemotherapy including sorafenib and sunitinib is allowed
Design
Phase II study
BMS-247550 will be administered on days 1 through 5 every 21 days
Restaging will be done every two cycles
BMS-247550 NSC 710428 ixabepilone is a semi-synthetic analog of the natural product epothilone B
The epothilones are a novel class of non-taxane microtubule-stabilizing agents obtained from the fermentation of the cellulose degrading myxobacteria Sorangium cellulosum
BMS-247550 is active against cancer models that are naturally insensitive to paclitaxel or have developed resistance to paclitaxel both in-vitro and in-vivo
Objectives
Establish the efficacy of the investigational agent BMS-247550 in patients with renal cell carcinoma when administered as a one hour infusion on day 1 to 5 every 21 days
Evaluate the plasma pharmacokinetics of BMS-247550
Explore the pharmacodynamics of BMS-247550 using an assay that measures the amount of endogenous tubulin in peripheral blood mononuclear cells PBMC that exists in the polymerized versus the unpolymerized state
Determine the extent to which pharmacodynamic changes are observed over a range of doses of BMS-247550
Determine if cross-resistance to BMS-247550 exists in patients who have previously received sorafenib or sunitinib
Eligibility
Age greater than 18
Pathological confirmation of renal cell carcinoma
Prior chemotherapy including sorafenib and sunitinib is allowed
Design
Phase II study
BMS-247550 will be administered on days 1 through 5 every 21 days
Restaging will be done every two cycles
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| 02-C-0130 | None | None | None |