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| Sponsor: | National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00658424 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Cancer |
Drug: MDR modulator CBT-1 Drug: paclitaxel Radiation: Tc 99m sestamibi |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Pharmacodynamic Study of the P-Glycoprotein (Pgp) Antagonist, CBT-1®, Evaluating Pgp Inhibition in Tumors and Normal Tissues |
| Estimated Enrollment: | 12 |
| Study Start Date: | September 2007 |
| Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologic or cytologic confirmation at NCI Laboratory of Pathology of cancer of any of the following subtypes:
No known standard therapy option capable of extending life expectancy
PATIENT CHARACTERISTICS:
No significant central nervous system (CNS) disease including either of the following:
PRIOR CONCURRENT THERAPY:
More than 4 weeks since prior radiation or chemotherapy (6 weeks since prior mitomycin)
Contacts and Locations| United States, Maryland | |
| Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Recruiting |
| Bethesda, Maryland, United States, 20892-1182 | |
| Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center 888-NCI-1937 | |
| Principal Investigator: | Susan E. Bates, MD | National Cancer Institute (NCI) |
More Information
| Study ID Numbers: | CDR0000583024, NCI-08-C-0035 |
| Study First Received: | April 12, 2008 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00658424 History of Changes |
| Health Authority: | Unspecified |
|
recurrent breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer stage IV breast cancer male breast cancer recurrent prostate cancer stage IV prostate cancer stage III prostate cancer recurrent borderline ovarian surface epithelial-stromal tumor recurrent ovarian epithelial cancer recurrent ovarian germ cell tumor stage IV borderline ovarian surface epithelial-stromal tumor stage IV ovarian epithelial cancer stage IV ovarian germ cell tumor |
stage III ovarian epithelial cancer stage III ovarian germ cell tumor stage III borderline ovarian surface epithelial-stromal tumor recurrent non-small cell lung cancer recurrent small cell lung cancer extensive stage small cell lung cancer stage IV non-small cell lung cancer stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer refractory multiple myeloma stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma recurrent anal cancer stage IV anal cancer |
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Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Paclitaxel Therapeutic Uses Mitosis Modulators |
Tubulin Modulators Antimitotic Agents Antineoplastic Agents, Phytogenic Pharmacologic Actions |