A Phase I Study Of The Safety Of Myo-Inositol As A Chemopreventive Agent
40 Years
74 Years
Both
Lung Cancer, Precancerous Condition
Trial Information
A Phase I Study Of The Safety Of Myo-Inositol As A Chemopreventive Agent
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Prevention
Principal Investigator
Stephen Lam, MD
Investigator Role:
Study Chair
Investigator Affiliation:
British Columbia Cancer Agency
Authority:
United States: Federal Government
Study ID:
CDR0000302633
NCT ID:
NCT00061997
Start Date:
May 2003
Completion Date:
Related Keywords:
- Lung Cancer
- Precancerous Condition
- non-small cell lung cancer
- small cell lung cancer
- precancerous condition
- Lung Neoplasms
- Precancerous Conditions
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