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| Descriptive Information Fields | |||||
| Brief Title † | CBT-1 and Paclitaxel in Treating Patients With Refractory, Recurrent, or Advanced Metastatic Solid Tumors | ||||
| Official Title † | A Pharmacodynamic Study of the P-Glycoprotein (Pgp) Antagonist, CBT-1®, Evaluating Pgp Inhibition in Tumors and Normal Tissues | ||||
| Brief Summary | RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. CBT-1 may help paclitaxel work better by making tumor cells more sensitive to the drug. PURPOSE: This clinical trial is studying how well giving CBT-1 together with paclitaxel works in treating patients with refractory, recurrent, or advanced metastatic solid tumors. |
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| Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE: Patients undergo a baseline 99mTc-sestamibi scan on day 0. Beginning on day 1, patients receive oral CBT-1® 2 or 3 times a day for 7 days and paclitaxel IV over 3 hours on day 6. Treatment repeats every 3 weeks for as long as benefit is shown. Patients will be restaged every other course. On day 5, patients undergo blood sampling for the rhodamine assay in CD56+ circulating mononuclear cells and imaging of tumors and normal tissue with the 99mTc-sestamibi radionuclide scan. |
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| Study Phase | |||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment | ||||
| Primary Outcome Measure † | Increased sestamibi retention [ Designated as safety issue: No ] | ||||
| Secondary Outcome Measure † | Treatment benefit [ Designated as safety issue: No ] | ||||
| Condition † | Cancer | ||||
| Intervention † | Drug: MDR modulator CBT-1 Drug: paclitaxel Drug: technetium 99m sestamibi |
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| MEDLINE PMIDs | |||||
| Links | Clinical trial summary from the National Cancer Institute's PDQ® database ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 12 | ||||
| Start Date † | September 2007 | ||||
| Completion Date | |||||
| Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00658424 | ||||
| Organization ID | CDR0000583024 | ||||
| Secondary IDs †† | NCI-08-C-0035 | ||||
| Study Sponsor † | NCI - Center for Cancer Research-Medical Oncology | ||||
| Collaborators †† | National Cancer Institute (NCI) | ||||
| Investigators † |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | April 2008 | ||||
| First Received Date † | April 12, 2008 | ||||
| Last Updated Date | November 13, 2008 | ||||