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Inositol in Preventing Lung Cancer in Patients With Bronchial Epithelial Dysplasia Who Are Current or Former Smokers

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00061997
First received: June 5, 2003
Last updated: February 1, 2010
Last verified: November 2005
History of Changes
  Purpose

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Inositol may be effective in preventing the development of lung cancer in patients with bronchial epithelial dysplasia.

PURPOSE: This phase I trial is studying the side effects and best dose of inositol in preventing lung cancer in current or former smokers with bronchial epithelial dysplasia.


Condition Intervention Phase
Lung Cancer
Precancerous Condition
 Dietary Supplement: inositol
 Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Prevention
Official Title: A Phase I Study Of The Safety Of Myo-Inositol As A Chemopreventive Agent

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Inositol
U.S. FDA Resources

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

Study Start Date: May 2003
Detailed Description:

OBJECTIVES:

  • Determine the safety of inositol for the prevention of lung cancer in patients with bronchial epithelial dysplasia who are current or former smokers.
  • Determine the potential efficacy of this drug in regression of existing dysplastic lesions or prevention of appearance of new dysplastic lesions in these patients.
  • Determine whether intake of this drug can facilitate smoking cessation in patients who are current smokers.

OUTLINE: This is a dose-escalation study.

Patients receive oral inositol twice daily. Treatment continues for 1 or 3 months in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-12 patients receive escalating doses of inositol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 12 patients experience dose-limiting toxicity.

Once the MTD is determined, 10 patients are treated with inositol twice daily at the MTD for 3 months in the absence of disease progression or unacceptable toxicity.

Patients are followed at 1 month.

PROJECTED ACCRUAL: A total of 3-28 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   40 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of persistent bronchial dysplasia despite regular twice-daily treatment with inhaled budesonide for 6 or 12 months on protocol BCCA-CIC-98-37
  • Current or former smokers who have smoked at least 30 pack years
  • Sputum cells showing AIC atypia by computer-assisted image analysis

  • At least 2 abnormal sites on fluorescence bronchoscopy (red/green ratio at least 0.45) suspicious for bronchial dysplasia

    • At least 1 site confirmed by bronchial biopsy
    • Solitary dysplastic lesion allowed provided the diameter is greater than 1.5 mm
  • No invasive cancer on bronchoscopy or abnormal low-dose spiral CT scan suspicious for lung cancer

PATIENT CHARACTERISTICS:

Age

  • 40 to 74

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Hematologic function normal
  • No bleeding disorder

Hepatic

  • Liver function normal
  • Liver enzymes no greater than upper limit of normal

Renal

  • Renal function normal

Cardiovascular

  • No unstable angina
  • No congestive heart failure

Pulmonary

  • No acute or chronic respiratory failure
  • No acute bronchitis or pneumonia within the past month

Other

  • Fasting glucose less than 144 mg/dL
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Willing to have a bronchoscopy
  • No schizophrenia
  • No bipolar disorder
  • No diabetes
  • No known reaction to topical xylocaine
  • No other medical condition that would jeopardize patient safety during study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior radiotherapy

Surgery

  • No prior surgery for lung cancer

Other

  • No concurrent lithium
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00061997

Locations
Canada, British Columbia
British Columbia Cancer Agency - Vancouver Cancer Centre
Vancouver, British Columbia, Canada, V5Z 4E6
Sponsors and Collaborators
British Columbia Cancer Agency
National Cancer Institute (NCI)
Investigators
Study Chair: Stephen Lam, MD British Columbia Cancer Agency
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00061997     History of Changes
Other Study ID Numbers: CDR0000302633, BCCA-U98-0411, BCCA-C02-0298
Study First Received: June 5, 2003
Last Updated: February 1, 2010
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
non-small cell lung cancer
small cell lung cancer
precancerous condition

Additional relevant MeSH terms:
Lung Neoplasms
Precancerous Conditions
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
 Inositol
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013