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.
Primary Outcome Measures:
- Increased sestamibi retention [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Treatment benefit [ Designated as safety issue: No ]
| Estimated Enrollment: |
12 |
| Study Start Date: |
September 2007 |
| Estimated Primary Completion Date: |
September 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
- To evaluate the impact of CBT-1® on the hepatic accumulation and retention of 99mTc-sestamibi in patients with relapsed or refractory solid tumor malignancies.
- To evaluate the impact of CBT-1® on P-glycoprotein-mediated efflux from CD56+ peripheral mononuclear cells.
Secondary
- Contribute response data to CBA Research, Inc. trial of CBT-1® and paclitaxel.
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.