• Increased sestamibi retention [ Designated as safety issue: No ]
  

• Treatment benefit [ Designated as safety issue: No ]
  

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.

DISEASE CHARACTERISTICS:

• Histologic or cytologic confirmation at NCI Laboratory of Pathology of cancer of any of the following subtypes:

  • Gastrointestinal tract
  • Breast, including paclitaxel-naive breast cancer
  • Small cell lung
  • Ovarian
  • Prostate
  • Head and neck
  • Multiple myeloma
  • Non-small cell lung cancer including paclitaxel-naive non-small cell lung cancer
• Recurrent or refractory, or advanced metastatic disease
• Measurable disease by radiographic means (measured in at least one dimension with longest diameter ≥ 20 mm using conventional techniques or ≥10 mm with spiral CT scan) or physical examination

• No known standard therapy option capable of extending life expectancy

  • Must not be eligible for surgery, or radiotherapy that is of known benefit to them, in terms of extension of survival
  • Patients with tumors sensitive to potentially curative chemotherapy must have failed such chemotherapy

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2
• Life expectancy ≥ 3 months
• Platelet count > 100,000/mL
• Absolute granulocyte count (AGC) > 1500/mL
• Serum creatinine < 2.0 mg/dl (or if > 2.0, a measured 24 hour creatinine clearance > 50 mL/min)
• SGOT ≤ 4 times normal
• Bilirubin ≤ 2.0 mg/dl
• PT and PTT ≤ 1.5 times normal
• Calcium < 5.3mEq/L
• Albumin > 2.0 g/dL
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and after the treatment
• No serious intercurrent medical illness or serious infection that requires parenteral antibiotics
• No HIV seropositive patients

• No significant central nervous system (CNS) disease including either of the following:

  • A history of seizures within the last 3 months
  • Psychiatric history which would impair the ability to give informed consent or prevent compliance with protocol requirements
• No history of significant coronary artery disease, cardiac arrhythmias requiring treatment, or history of other cardiac disease
• No active bleeding due to peptic ulcer disease
• No other clinically significant bleeding disorders
• No history of anaphylactic reactions to paclitaxel or Cremophor despite adequate premedication

PRIOR CONCURRENT THERAPY:

• More than 2 weeks since prior hormonal or immunotherapy

• More than 4 weeks since prior radiation or chemotherapy (6 weeks since prior mitomycin)

  • Patients who have received radiation therapy may participate in this study one week after the conclusion of radiation therapy provided that the lesion being irradiated is not one that is being used to assess the efficacy of CBT-1 plus paclitaxel
• More than 4 weeks since prior experimental therapy
• More than 8 weeks since prior UCNO1 treatment
• Patients receiving dexamethasone as a pretreatment for anaphylactic reactions to paclitaxel or the Cremophor vehicle allowed
• No prior solid organ allograft
• Not on daily gastric acid secretion inhibitors