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CBT-1 and Paclitaxel in Treating Patients With Refractory, Recurrent, or Advanced Metastatic Solid Tumors
This study is currently recruiting participants.
Study NCT00658424   Information provided by National Cancer Institute (NCI)
First Received: April 12, 2008   Last Updated: February 6, 2009   History of Changes

April 12, 2008
February 6, 2009
September 2007
September 2008   (final data collection date for primary outcome measure)
Increased sestamibi retention [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00658424 on ClinicalTrials.gov Archive Site
Treatment benefit [ Designated as safety issue: No ]
Same as current
 
CBT-1 and Paclitaxel in Treating Patients With Refractory, Recurrent, or Advanced Metastatic Solid Tumors
A Pharmacodynamic Study of the P-Glycoprotein (Pgp) Antagonist, CBT-1®, Evaluating Pgp Inhibition in Tumors and Normal Tissues

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.

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.

 
Interventional
Treatment
Cancer
  • Drug: MDR modulator CBT-1
  • Drug: paclitaxel
  • Radiation: Tc 99m sestamibi
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
12
 
September 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
 
United States
 
NCT00658424
 
CDR0000583024, NCI-08-C-0035
National Cancer Institute (NCI)
 
Principal Investigator: Susan E. Bates, MD National Cancer Institute (NCI)
National Cancer Institute (NCI)
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP