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CompletedNCT0000258613-CisUpdated May 15, 2020

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

A Phase 2 interventional study of 13-cis retinoic acid and Tocopherol in Drug Toxicity and Lung Cancer, sponsored by University of Colorado, Denver. Completed at 4 sites in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2020-05-15.

Sponsored by University of Colorado, Denver · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
96
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

Read the detailed description

OBJECTIVES:

  • 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.

02

Conditions studied

  • Drug Toxicity
  • Lung Cancer

Keywords

  • non-small cell lung cancer
  • small cell lung cancer
  • drug/agent toxicity by tissue/organ
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 96 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

University of Colorado, Denver is the lead sponsor of 1,499 studies on the registry; 315 are open to participants now.

Of its 139 completed or terminated interventional studies of FDA-regulated products, 89 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
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

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
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
96 participants (actual)

Study arms

  • Experimental
    13-cis retinoic acid

    13-cis retinoic acid 50 mg/d

    Drug: 13-cis retinoic acid

  • Experimental
    13-Cis Retinoic Acid and Tocopherol

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

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

  • No intervention
    Observation

    Observation

Interventions

  • Drug13-cis retinoic acid

    Also known as: Isotretinoin, AccutaneT

  • Dietary supplementTocopherol

    Also known as: Vitamin E

06

What researchers measure

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

    Time frame: Three years

07

Study locations

4 sites
  • University of Colorado Cancer Center at University of Colorado Health Sciences Center
    Denver, Colorado 80010, United States
  • National Jewish Center for Immunology and Respiratory Medicine
    Denver, Colorado 80206, United States
  • Lung Cancer Institute
    Denver, Colorado 80218, United States
  • Veterans Affairs Medical Center - Denver
    Denver, Colorado 80220, United States
08

References and documents

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). 2009 May;2(5):440-9. doi: 10.1158/1940-6207.CAPR-08-0136. Epub 2009 Apr 28. PubMed 19401528 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 15, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00002586
Lead sponsor
University of Colorado, Denver
Responsible party
Sponsor
First posted
Jan 27, 2003
Start date
Jan 1993
Primary completion
Dec 2005
Completion
Dec 2005
Last update
May 15, 2020

Study contacts

York E. Miller, MD
principal investigator · University of Colorado, Denver

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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