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Trial record 52 of 163 for:    ISOTRETINOIN

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002586
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : May 7, 2014
Information provided by (Responsible Party):
University of Colorado, Denver

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.

Condition or disease Intervention/treatment Phase
Drug Toxicity Lung Cancer Drug: 13-cis retinoic acid Dietary Supplement: Tocopherol Phase 2

Detailed Description:


  • To determine if alpha tocopherol can reduce the toxicities of low dose 13-cis retinoic acid administered for one year.
  • To access the adequacy of the collected specimens for studies of intermediate endpoint markers.
  • to establish a depository of biologic specimens for future studies of new biomarkers.

    • Arm 1: Patients receive oral 13-cis retinoic acid daily.
    • Arm 2: Patients receive oral 13-cis retinoic acid and oral vitamin E daily.
    • Arm 3: 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 100 patients (33 Arm 1, 33 Arm 2, and 34 Arm 3) will be accrued for this study within 3 years.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Study Start Date : January 1993
Actual Primary Completion Date : December 2005
Actual Study Completion Date : December 2005

Arm Intervention/treatment
Experimental: 13-cis retinoic acid
13-cis retinoic acid 50 mg/d
Drug: 13-cis retinoic acid
Other Name: Isotretinoin, AccutaneT

Experimental: 13-Cis Retinoic Acid and Tocopherol
13-Cis Retinoic Acid (50 mg/day) Tocopherol (800 mg/day)
Drug: 13-cis retinoic acid
Other Name: Isotretinoin, AccutaneT

Dietary Supplement: Tocopherol
Other Name: Vitamin E

No Intervention: Observation

Primary Outcome Measures :
  1. Treatment failure [ Time Frame: Three years ]
    Treatment "failure" defined as histologic progression (any increase in the maximum histologic score) or failure to return for follow-up bronchoscopy

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. 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.
  2. Patients must have at least a 30 pack year smoking history.
  3. Patients must be a current smoker or ex-smoker who have not smoked for at least 6 months more.
  4. Patients must have peripheral granulocyte count of > 1500 and platelet count of > 150,000.
  5. Patients must have adequate hepatic function with bilirubin < 1.5 mg % and SGPT < 4 times institutional upper limits of normal.
  6. Patients must have adequate renal function with serum creatinine < 1.5 mg %.
  7. 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.

Exclusion Criteria:

  1. 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.
  2. Patients must have no serious intercurrent illness including insulin dependent diabetes mellitus or hypercholesterolemia (>239mg/dl) / hypertriglyceridemia (>149mg/dl).
  3. 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.
  4. Patients must not have cardiac dysrhythmia that is potentially life threatening such as ventricular tachycardia, multifocal premature ventricular contractions or supraventricular tachycardias with a rapid ventricular response. Well controlled atrial fibrillation or rare (<2/minute) premature ventricular contractions are not exclusionary
  5. Chest x-ray must not show evidence of tumor.
  6. Patients must not be taking vitamin A or E supplements
  7. Patients must not be taking tetracycline or minocycline.
  8. Patients who have had prior chemotherapy or radiation therapy.
  9. Women who are pregnant are ineligible

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00002586

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United States, Colorado
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Denver, Colorado, United States, 80010
National Jewish Center for Immunology and Respiratory Medicine
Denver, Colorado, United States, 80206
Lung Cancer Institute
Denver, Colorado, United States, 80218
Veterans Affairs Medical Center - Denver
Denver, Colorado, United States, 80220
Sponsors and Collaborators
University of Colorado, Denver
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Principal Investigator: York E. Miller, MD University of Colorado, Denver

Publications of Results:
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Responsible Party: University of Colorado, Denver Identifier: NCT00002586     History of Changes
Other Study ID Numbers: 92-0382
NCI-V94-0506 ( Other Grant/Funding Number: National Cancer Institute )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: May 7, 2014
Last Verified: May 2014
Keywords provided by University of Colorado, Denver:
non-small cell lung cancer
small cell lung cancer
drug/agent toxicity by tissue/organ
Additional relevant MeSH terms:
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Lung Neoplasms
Drug-Related Side Effects and Adverse Reactions
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Chemically-Induced Disorders
Vitamin E
Growth Substances
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Protective Agents
Antineoplastic Agents
Keratolytic Agents
Dermatologic Agents