13-Cis Retinoic Acid With or Without Vitamin E for Prevention of Lung Cancer

NCT00002586 | Completed Phase 2 DMC

• 2 other identifiers: 92-0382NCI-V94-0506
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 4

Brief Summary

RATIONALE: 13 Cis retinoic acid may prevent the development of cancer cells. PURPOSE: Randomized double-blinded phase II trial to study the effectiveness of 13-cis retinoic acid with or without vitamin E for chemoprevention or observation of cancer in persons at high risk of developing lung cancer.

Conditions

Drug Toxicity; Lung Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Treatment failure

  Treatment "failure" defined as histologic progression (any increase in the maximum histologic score) or failure to return for follow-up bronchoscopy

  Three years

Study Arms (3)

13-cis retinoic acid

EXPERIMENTAL

13-cis retinoic acid 50 mg/d

Drug: 13-cis retinoic acid

13-Cis Retinoic Acid and Tocopherol

EXPERIMENTAL

13-Cis Retinoic Acid (50 mg/day) Tocopherol (800 mg/day)

Drug: 13-cis retinoic acid; Dietary Supplement: Tocopherol

Observation

NO INTERVENTION

Observation

Interventions

13-cis retinoic acid DRUG

Also known as: Isotretinoin, AccutaneT

13-Cis Retinoic Acid and Tocopherol; 13-cis retinoic acid

Tocopherol DIETARY_SUPPLEMENT

Also known as: Vitamin E

13-Cis Retinoic Acid and Tocopherol

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients identified through the Tissue Procurement/Screening Project with mild, moderate or severe dysplasia, Ca In situ OR surgically cured patients with head and neck cancer who are found to have mild atypia or greater on their staging bronchoscopy. (This includes carcinoma in situ). Also eligible are patients with Stage I and II non-small cell lung cancer who are disease free greater than 36 months.
• Patients must have at least a 30 pack year smoking history.
• Patients must be a current smoker or ex-smoker who have not smoked for at least 6 months more.
• Patients must have peripheral granulocyte count of \> 1500 and platelet count of \> 150,000.
• Patients must have adequate hepatic function with bilirubin \< 1.5 mg % and SGPT \< 4 times institutional upper limits of normal.
• Patients must have adequate renal function with serum creatinine \< 1.5 mg %.
• All patients must be informed of the investigational nature of the study and must sign and give written informed consent in accordance with institutional and federal guidelines.

You may not qualify if:

• Patients must not have a current or past history of cancer within the past 5 years with the exception of surgically cured head and neck cancer or surgically cured Stage I or II lung cancer \> 36 months from diagnosis or skin cancer or in situ cancers.
• Patients must have no serious intercurrent illness including insulin dependent diabetes mellitus or hypercholesterolemia (\>239mg/dl) / hypertriglyceridemia (\>149mg/dl).
• Patients must not have evidence of clinically active coronary artery disease including myocardial infarction within 6 weeks, chest pain or poorly controlled congestive heart failure or any other serious medical condition, which would preclude a patient from undergoing a bronchoscopy.
• Chest x-ray must not show evidence of tumor.
• Patients must not be taking vitamin A or E supplements
• Patients must not be taking tetracycline or minocycline.
• Patients who have had prior chemotherapy or radiation therapy.
• Women who are pregnant are ineligible

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (4)

University of Colorado Cancer Center at University of Colorado Health Sciences Center

Denver, Colorado, 80010, United States

Location

National Jewish Center for Immunology and Respiratory Medicine

Denver, Colorado, 80206, United States

Location

Lung Cancer Institute

Denver, Colorado, 80218, United States

Location

Veterans Affairs Medical Center - Denver

Denver, Colorado, 80220, United States

Location

Related Publications (1)

• 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). 2009 May;2(5):440-9. doi: 10.1158/1940-6207.CAPR-08-0136. Epub 2009 Apr 28.

  PMID: 19401528 RESULT

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma

Interventions

Isotretinoin; Tocopherols; Vitamin E

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• York E. Miller, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: January 1, 1993
• Primary Completion: December 1, 2005
• Study Completion: December 1, 2005
• Last Updated: May 15, 2020

Record last verified: 2020-05

Locations

US (4)