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

Primary Purpose

Lung Cancer, Precancerous Condition

Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
inositol
Sponsored by
British Columbia Cancer Agency
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Lung Cancer focused on measuring non-small cell lung cancer, small cell lung cancer, precancerous condition

Eligibility Criteria

40 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • British Columbia Cancer Agency - Vancouver Cancer Centre

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 5, 2003
Last Updated
February 1, 2010
Sponsor
British Columbia Cancer Agency
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00061997
Brief Title
Inositol in Preventing Lung Cancer in Patients With Bronchial Epithelial Dysplasia Who Are Current or Former Smokers
Official Title
A Phase I Study Of The Safety Of Myo-Inositol As A Chemopreventive Agent
Study Type
Interventional

2. Study Status

Record Verification Date
November 2005
Overall Recruitment Status
Completed
Study Start Date
May 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
British Columbia Cancer Agency
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Precancerous Condition
Keywords
non-small cell lung cancer, small cell lung cancer, precancerous condition

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1

8. Arms, Groups, and Interventions

Intervention Type
Dietary Supplement
Intervention Name(s)
inositol

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Lam, MD
Organizational Affiliation
British Columbia Cancer Agency
Official's Role
Study Chair
Facility Information:
Facility Name
British Columbia Cancer Agency - Vancouver Cancer Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada

12. IPD Sharing Statement

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

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