Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Related Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Prevention	Completed	40 to 74	NCI	BCCA-U98-0411 BCCA-C02-0298, NCT00061997

Objectives

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

Entry 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

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

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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

British Columbia Cancer Agency - Vancouver Cancer Centre

Stephen Lam, MD, Protocol chair		Ph: 604-675-8089; 800-663-3333

Related Information

PDQ® clinical trial BCCA-CIC-98-37

Registry Information
Official Title		A Phase I Study Of The Safety Of Myo-Inositol As A Chemopreventive Agent
Trial Start Date		2003-05-26
Registered in ClinicalTrials.gov		NCT00061997
Date Submitted to PDQ		2003-04-15
Information Last Verified		2005-11-22
NCI Grant/Contract Number		N01-CN85188

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