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ASSESSMENT OF INTERMEDIATE ENDPOINT BIOMARKERS TO 13-CIS RETINOIC ACID WITH OR WITHOUT ALPHA TOCOPHEROL OR OBSERVATION


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Drug/Agent Toxicity by Tissue/Organ, Lung Cancer

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Trial Information

ASSESSMENT OF INTERMEDIATE ENDPOINT BIOMARKERS TO 13-CIS RETINOIC ACID WITH OR WITHOUT ALPHA TOCOPHEROL OR OBSERVATION


OBJECTIVES:

- Determine whether any intermediate endpoint biomarkers in patients at high risk for the
development of lung cancer change after treatment with isotretinoin given with or
without vitamin E.

- Determine whether vitamin E can reduce the toxic effects of low-dose isotretinoin
administered for 1 year in these patients.

OUTLINE: This is a randomized, double-blind study. Patients are stratified according to
smoking status (smoker vs ex-smoker).

All patients undergo bronchoscopy. All observed lesions are biopsied. Patients are then
randomized to one of three treatment arms.

- Arm I: Patients receive oral isotretinoin daily.

- Arm II: Patients receive oral isotretinoin and oral vitamin E daily.

- Arm III: Patients undergo observation only. Treatment continues in arms I and II for 1
year in the absence of unacceptable toxicity.

Patients are followed annually for 2 years.

PROJECTED ACCRUAL: A total of 60 patients (20 per arm) will be accrued for this study within
3 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Current smokers with at least a 40-pack/year history OR

- Former smokers considered at high risk for the development of lung cancer

- At least a 40-pack/year history

- No smoking in the past 12 months

- At least 1 of the following high-risk conditions:

- Mild, moderate, or severe dysplasia

- Carcinoma in situ

- Surgically cured head and neck cancer with at least mild atypia on staging
bronchoscopy (includes carcinoma in situ)

- No pneumonia or acute bronchitis requiring antibiotics within past 2 months prior to
entry

- No evidence of tumor on chest x-ray

PATIENT CHARACTERISTICS:

Age:

- Over 18

Performance status:

- Not specified

Life expectancy:

- Not specified

Hematopoietic:

- Granulocyte count greater than 1,500/mm^3

- Platelet count greater than 200,000/mm^3

Hepatic:

- Bilirubin less than 1.5 mg/dL

- ALT less than 4 times upper limit of normal

- No hypercholesterolemia/hypertriglyceridemia

Renal:

- Creatinine less than 1.5 mg/dL

Cardiovascular:

- No active atherosclerotic cardiovascular disease (angina, claudication)

Other:

- No other malignancy within past 5 years except surgically cured skin cancer or in
situ cancer

- No insulin-dependent diabetes mellitus

- No history of abnormal bleeding

- No other serious concurrent illness

- No fertile women

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- Not specified

Endocrine therapy

- Not specified

Radiotherapy

- Not specified

Surgery

- See Disease Characteristics

Other

- See Disease Characteristics

- No concurrent tetracycline or minocycline

- No concurrent vitamin supplements

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention

Principal Investigator

Karen Kelly, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Colorado, Denver

Authority:

United States: Federal Government

Study ID:

CDR0000063730

NCT ID:

NCT00002586

Start Date:

January 1993

Completion Date:

Related Keywords:

  • Drug/Agent Toxicity by Tissue/Organ
  • Lung Cancer
  • non-small cell lung cancer
  • small cell lung cancer
  • drug/agent toxicity by tissue/organ
  • Lung Neoplasms

Name

Location

University of Colorado Cancer Center at University of Colorado Health Sciences CenterDenver, Colorado  80010
Veterans Affairs Medical Center - DenverDenver, Colorado  80220
Lung Cancer InstituteDenver, Colorado  80218
National Jewish Center for Immunology and Respiratory MedicineDenver, Colorado  80206