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

NCT00061997 | Completed Phase 1

• 3 other identifiers: CDR0000302633BCCA-U98-0411BCCA-C02-0298
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer; Precancerous Condition

Keywords

non-small cell lung cancer; small cell lung cancer; precancerous condition

Interventions

inositol DIETARY_SUPPLEMENT

Eligibility Criteria

• Age: 40 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• British Columbia Cancer Agency: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

British Columbia Cancer Agency - Vancouver Cancer Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

MeSH Terms

Conditions

Lung Neoplasms; Precancerous Conditions; Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma

Interventions

Inositol

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates

Study Officials

• Stephen Lam, MD

  British Columbia Cancer Agency

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: PREVENTION
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 5, 2003
• First Posted: June 6, 2003
• Study Start: May 1, 2003
• Last Updated: February 2, 2010

Record last verified: 2005-11

Locations

CA (1)