Isotretinoin With or Without Vitamin E for Prevention of Lung Cancer - Full Text View

Sponsor:	University of Colorado at Denver and Health Sciences Center
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00002586

Purpose

RATIONALE: Isotretinoin may prevent the development of cancer cells.

PURPOSE: Randomized double-blinded phase II trial to study the effectiveness of isotretinoin with or without vitamin E for chemoprevention of cancer in persons at high risk of developing lung cancer.

Condition	Intervention	Phase
Drug/Agent Toxicity by Tissue/Organ Lung Cancer	Dietary Supplement: vitamin E Drug: isotretinoin	Phase II

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Active Control
Official Title:	ASSESSMENT OF INTERMEDIATE ENDPOINT BIOMARKERS TO 13-CIS RETINOIC ACID WITH OR WITHOUT ALPHA TOCOPHEROL OR OBSERVATION

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: alpha-Tocopheryl acetate alpha-Tocopherol Vitamin E Tocopherols Isotretinoin Tocotrienol

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:	60
Study Start Date:	January 1993

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002586

Locations

United States, Colorado
Lung Cancer Institute
Denver, Colorado, United States, 80218
National Jewish Center for Immunology and Respiratory Medicine
Denver, Colorado, United States, 80206
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Denver, Colorado, United States, 80010
Veterans Affairs Medical Center - Denver
Denver, Colorado, United States, 80220

Sponsors and Collaborators

University of Colorado at Denver and Health Sciences Center

Investigators

Study Chair:

Karen Kelly, MD

University of Colorado at Denver and Health Sciences Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Kelly K, Kittelson J, Franklin WA, Kennedy TC, Klein CE, Keith RL, Dempsey EC, Lewis M, Jackson MK, Hirsch FR, Bunn PA, Miller YE. A randomized phase II chemoprevention trial of 13-CIS retinoic acid with or without alpha tocopherol or observation in subjects at high risk for lung cancer. Cancer Prev Res (Phila Pa). 2009 May;2(5):440-9. Epub 2009 Apr 28.

Study ID Numbers:	CDR0000063730, UCHSC-92382, NCI-V94-0506
Study First Received:	November 1, 1999
Last Updated:	October 21, 2009
ClinicalTrials.gov Identifier:	NCT00002586 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

non-small cell lung cancer
small cell lung cancer
drug/agent toxicity by tissue/organ

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Tocopherol acetate
Antioxidants
Molecular Mechanisms of Pharmacological Action
Growth Substances
Physiological Effects of Drugs
Protective Agents
Pharmacologic Actions
Alpha-Tocopherol
Tocopherols
Neoplasms

Vitamin E
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Vitamins
Lung Diseases
Isotretinoin
Tocotrienols
Micronutrients
Dermatologic Agents

ClinicalTrials.gov processed this record on November 30, 2009