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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | April 12, 2008 | ||||
| Last Updated Date | February 6, 2009 | ||||
| Start Date ICMJE | September 2007 | ||||
| Estimated Primary Completion Date | September 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Increased sestamibi retention [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00658424 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Treatment benefit [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | CBT-1 and Paclitaxel in Treating Patients With Refractory, Recurrent, or Advanced Metastatic Solid Tumors | ||||
| Official Title ICMJE | 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 ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment | ||||
| Condition ICMJE | Cancer | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 12 | ||||
| Completion Date | |||||
| Estimated Primary Completion Date | September 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | |||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00658424 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000583024, NCI-08-C-0035 | ||||
| Study Sponsor ICMJE | National Cancer Institute (NCI) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | April 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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