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

Tracking Information

First Received Date ^ICMJE

November 1, 1999

Last Updated Date

October 21, 2009

Start Date ^ICMJE

January 1993

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00002586 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Isotretinoin With or Without Vitamin E for Prevention of Lung Cancer

Official Title ^ICMJE

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

Brief Summary

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.

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.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Double-Blind, Active Control

Condition ^ICMJE

Drug/Agent Toxicity by Tissue/Organ
Lung Cancer

Intervention ^ICMJE

Dietary Supplement: vitamin E
Drug: isotretinoin

Study Arms / Comparison Groups

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00002586

Responsible Party

Study ID Numbers ^ICMJE

CDR0000063730, UCHSC-92382, NCI-V94-0506

Study Sponsor ^ICMJE

University of Colorado at Denver and Health Sciences Center

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Karen Kelly, MD

University of Colorado at Denver and Health Sciences Center

Information Provided By

National Cancer Institute (NCI)

Verification Date

December 2003

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP