Breast Clinical Trial
Official title:
A Pharmacodynamic Study of the P-glycoprotein (Pgp) Antagonist, CBT-1(Registered Trademark), Evaluating Pgp Inhibition in Tumors and Normal Tissues
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-1(Registered 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-1(Registered 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-1(Registered 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-1(Registered 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-1(Registered 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-1(Registered 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-1(Registered Trademark). This scan helps show how well the P-glycoprotein pump is being
blocked by the treatment.
Background:
This is a pharmacodynamic study aimed at evaluating the efficacy of CBT-1(Registered
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-1(Registered
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-1(Registered Trademark) on the hepatic accumulation and retention
of 99mTc-sestamibi in patients with relapsed or refractory solid tumor malignancies.
Evaluate the impact of CBT-1(Registered Trademark) on P-glycoprotein-mediated efflux from
CD56 plus peripheral mononuclear cells.
Eligibility:
Patients over 18 years of age who have histologic confirmation of relapsed/refractory
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-1(Registered Trademark)
in two or three divided doses daily for 7 days. On day 6, 135 mg/m^2 paclitaxel will be
administered by intravenous infusion over 3 hours. Prior to the initiation of
CBT-1(Registered 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-1(Registered Trademark) with
previous inhibitors tested in the intramural program.
;
Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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