Lung CancerPhase 1NCT00061997
Inositol in Preventing Lung Cancer in Patients With Bronchial Epithelial Dysplasia Who Are Current or Former Smokers
A Phase 1 study testing inositol in people with Lung Cancer and Precancerous Condition, run by British Columbia Cancer Agency at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 74 years
- Conditions the study is for
- Lung Cancer, Precancerous Condition
- What is being tested?
- inositol
- How many people
- Not given
- Where
- 1 siteCanada
- Study dates
- May 2003to not given
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
Canada1 site
British Columbia Cancer Agency - Vancouver Cancer Centre
Vancouver, British Columbia, V5Z 4E6
About this study
Official title: A Phase I Study Of The Safety Of Myo-Inositol As A Chemopreventive Agent
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.
Read the 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.
- Conditions
- Lung Cancer, Precancerous Condition
- Being tested
- inositol
- Keywords
- non-small cell lung cancer, small cell lung cancer, precancerous condition
- Medical subject headings
- Lung Neoplasms, Precancerous Conditions, Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inositolDietary supplement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2003 (estimated)
- Study startMay 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by British Columbia Cancer AgencyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
Sponsor and investigators
- Lead sponsor
- British Columbia Cancer Agency
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Stephen Lam, MD, Study chair, British Columbia Cancer Agency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00061997
- Sponsor's protocol ID
- CDR0000302633
- Other IDs
- BCCA-U98-0411, BCCA-C02-0298
- Status last verified
- Nov 2005
- First submitted
- 5 Jun 2003
- Last updated
- 2 Feb 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study Of The Safety Of Myo-Inositol As A Chemopreventive Agent
- ClinicalTrials.gov ID
- NCT00061997
- Acronym / sponsor ID
- CDR0000302633
- Conditions
- Lung Cancer, Precancerous Condition
- Keywords
- non-small cell lung cancer, small cell lung cancer, precancerous condition
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- British Columbia Cancer AgencyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2003
- First posted
- 6 Jun 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
Who may qualify
- Ages
- 40 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| inositol | Dietary supplement | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Lam, MD study chair
British Columbia Cancer Agency
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing inositol in people with Lung Cancer and Precancerous Condition, run by British Columbia Cancer Agency at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2010.