A Phase I Study Of The Safety Of Myo-Inositol As A Chemopreventive Agent


Phase 1
40 Years
74 Years
Not Enrolling
Both
Lung Cancer, Precancerous Condition

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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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