Ignite Creation Date:
2024-05-05 @ 9:49 PM
Last Modification Date:
2024-10-26 @ 10:10 AM
Study NCT ID:
NCT00972205
Status:
COMPLETED
Last Update Posted:
2012-07-19
First Post:
2009-09-03
Brief Title:
Paclitaxel and CBT-1Registered Trademark to Treat Solid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Pharmacodynamic Study of the P-glycoprotein Pgp Antagonist CBT-1Registered Trademark Evaluating Pgp Inhibition in Tumors and Normal Tissues
Status:
COMPLETED
Status Verified Date:
2012-07
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:
Background
Some cancer cells have a large amount of a protein called P-glycoprotein which can pump certain chemotherapy drugs out of their cells This pump may be part of the reason why it is difficult to shrink some cancers with chemotherapy
In laboratory experiments the drug CBT-1Registered Trademark blocked the P-glycoprotein pump resulting in accumulation of higher amounts of chemotherapy inside the cancer cells making the chemotherapy more effective
Paclitaxel is a cancer drug that has caused tumors to shrink in many types of cancers including lung ovarian breast renal cervical and others
Objectives
To determine whether CBT-1Registered Trademark can block the P-glycoprotein pump on cancer cells and whether it inhibits the action of the pump found in normal blood cells and liver tissue
To evaluate the effectiveness of combination therapy using CBT-1Registered Trademark and paclitaxel in treating solid tumors and to determine whether the two drugs together are more effective than paclitaxel alone
Eligibility
-Patients over 18 years of age who have a solid tumor that cannot be treated successfully with standard treatments
Design
-Patients receive CBT-1Registered Trademark and paclitaxel in 21-day cycles Treatment continues for two cycles after all the cancer is gone or until it is decided to surgically remove some or all of the remaining cancer or until the cancer has grown to the point where it defined as progressive disease
For each cycle patients take CBT-1Registered Trademark by mouth in three divided doses daily for 7 days On day 6 paclitaxel is given through a vein over 3 hours
Blood tests are done before starting CBT-1Registered Trademark and repeated periodically throughout treatment
Imaging studies computed tomography or magnetic resonance imaging CT or MRI are done every two cycles In addition for the first cycle only patients undergo imaging of tumors and normal tissue with a 99mTc-sestamibi radionuclide scan before and after administration of CBT-1Registered Trademark This scan helps show how well the P-glycoprotein pump is being blocked by the treatment
Some cancer cells have a large amount of a protein called P-glycoprotein which can pump certain chemotherapy drugs out of their cells This pump may be part of the reason why it is difficult to shrink some cancers with chemotherapy
In laboratory experiments the drug CBT-1Registered Trademark blocked the P-glycoprotein pump resulting in accumulation of higher amounts of chemotherapy inside the cancer cells making the chemotherapy more effective
Paclitaxel is a cancer drug that has caused tumors to shrink in many types of cancers including lung ovarian breast renal cervical and others
Objectives
To determine whether CBT-1Registered Trademark can block the P-glycoprotein pump on cancer cells and whether it inhibits the action of the pump found in normal blood cells and liver tissue
To evaluate the effectiveness of combination therapy using CBT-1Registered Trademark and paclitaxel in treating solid tumors and to determine whether the two drugs together are more effective than paclitaxel alone
Eligibility
-Patients over 18 years of age who have a solid tumor that cannot be treated successfully with standard treatments
Design
-Patients receive CBT-1Registered Trademark and paclitaxel in 21-day cycles Treatment continues for two cycles after all the cancer is gone or until it is decided to surgically remove some or all of the remaining cancer or until the cancer has grown to the point where it defined as progressive disease
For each cycle patients take CBT-1Registered Trademark by mouth in three divided doses daily for 7 days On day 6 paclitaxel is given through a vein over 3 hours
Blood tests are done before starting CBT-1Registered Trademark and repeated periodically throughout treatment
Imaging studies computed tomography or magnetic resonance imaging CT or MRI are done every two cycles In addition for the first cycle only patients undergo imaging of tumors and normal tissue with a 99mTc-sestamibi radionuclide scan before and after administration of CBT-1Registered Trademark This scan helps show how well the P-glycoprotein pump is being blocked by the treatment
Detailed Description:
Background
This is a pharmacodynamic study aimed at evaluating the efficacy of CBT-1Registered Trademark as a modulator of Pgp-mediated drug efflux in patient tumors and normal tissues The study will build on over a decade of experience with 99mTc-sestamibi imaging and rhodamine accumulation and efflux in normal circulating CD56 plus cells as surrogates for Pgp function CBA Research Inc has carried out Phase I and II testing of CBT-1Registered Trademark as a drug resistance reversal agent but has not yet confirmed that the inhibitor is able to block drug efflux
Objectives
Evaluate the impact of CBT-1Registered Trademark on the hepatic accumulation and retention of 99mTc-sestamibi in patients with relapsed or refractory solid tumor malignancies
Evaluate the impact of CBT-1Registered Trademark on P-glycoprotein-mediated efflux from CD56 plus peripheral mononuclear cells
Eligibility
Patients over 18 years of age who have histologic confirmation of relapsedrefractory cancer following at least once standard treatment regimen for whom there is no known standard therapy option capable of extending life expectancy Patients must have an Eastern Cooperative Oncology Group ECOG performance status of 2 or better and have hematologic renal hepatic and metabolic parameters suggestive of adequate organ function
Design
Patients will be treated according to CBA Research Phase II trial of CBT-1 and Taxol Patients will begin protocol treatment with orally administered CBT-1Registered Trademark in two or three divided doses daily for 7 days On day 6 135 mgm2 paclitaxel will be administered by intravenous infusion over 3 hours Prior to the initiation of CBT-1Registered Trademark and on Day 6 patients will undergo blood sampling for the rhodamine assay in CD56 plus circulating mononuclear cells In addition patients will undergo imaging of tumors and normal tissue with the 99mTc-sestamibi radionuclide scan These two assays have shown convincing inhibition of Pgp-mediated drug efflux in past studies with Pgp inhibitors such as tariquidar and valspodar Twelve patients are planned for enrollment to this study which is powered to determine a difference between the control scan and the post-treatment scan but not to compare CBT-1Registered Trademark with previous inhibitors tested in the intramural program
This is a pharmacodynamic study aimed at evaluating the efficacy of CBT-1Registered Trademark as a modulator of Pgp-mediated drug efflux in patient tumors and normal tissues The study will build on over a decade of experience with 99mTc-sestamibi imaging and rhodamine accumulation and efflux in normal circulating CD56 plus cells as surrogates for Pgp function CBA Research Inc has carried out Phase I and II testing of CBT-1Registered Trademark as a drug resistance reversal agent but has not yet confirmed that the inhibitor is able to block drug efflux
Objectives
Evaluate the impact of CBT-1Registered Trademark on the hepatic accumulation and retention of 99mTc-sestamibi in patients with relapsed or refractory solid tumor malignancies
Evaluate the impact of CBT-1Registered Trademark on P-glycoprotein-mediated efflux from CD56 plus peripheral mononuclear cells
Eligibility
Patients over 18 years of age who have histologic confirmation of relapsedrefractory cancer following at least once standard treatment regimen for whom there is no known standard therapy option capable of extending life expectancy Patients must have an Eastern Cooperative Oncology Group ECOG performance status of 2 or better and have hematologic renal hepatic and metabolic parameters suggestive of adequate organ function
Design
Patients will be treated according to CBA Research Phase II trial of CBT-1 and Taxol Patients will begin protocol treatment with orally administered CBT-1Registered Trademark in two or three divided doses daily for 7 days On day 6 135 mgm2 paclitaxel will be administered by intravenous infusion over 3 hours Prior to the initiation of CBT-1Registered Trademark and on Day 6 patients will undergo blood sampling for the rhodamine assay in CD56 plus circulating mononuclear cells In addition patients will undergo imaging of tumors and normal tissue with the 99mTc-sestamibi radionuclide scan These two assays have shown convincing inhibition of Pgp-mediated drug efflux in past studies with Pgp inhibitors such as tariquidar and valspodar Twelve patients are planned for enrollment to this study which is powered to determine a difference between the control scan and the post-treatment scan but not to compare CBT-1Registered Trademark with previous inhibitors tested in the intramural program
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 |
|---|---|---|---|
| 08-C-0035 | None | None | None |