Full Text View
Tabular View
No Study Results Posted
Related Studies
CBT-1 and Paclitaxel in Treating Patients With Refractory, Recurrent, or Advanced Metastatic Solid Tumors
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), April 2008
First Received: April 12, 2008   Last Updated: February 6, 2009   History of Changes
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

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)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00658424

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        
Sponsors and Collaborators
Investigators
Principal Investigator: Susan E. Bates, MD National Cancer Institute (NCI)
  More Information

Additional Information:
No publications provided

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

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Paclitaxel
Therapeutic Uses
Mitosis Modulators
Tubulin Modulators
Antimitotic Agents
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 30, 2009