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

May 13, 2020 updated by: University of Colorado, Denver

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Observation
Experimental: 13-cis retinoic acid
13-cis retinoic acid 50 mg/d
Drug: 13-cis retinoic acid
Other Names:
  • 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 Names:
  • Isotretinoin, AccutaneT
Dietary supplement: Tocopherol
Other Names:
  • Vitamin E

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Three years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Investigators

  • Principal Investigator: York E. Miller, MD, University of Colorado, Denver

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1993

Primary Completion (Actual)

December 1, 2005

Study Completion (Actual)

December 1, 2005

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Actual)

May 15, 2020

Last Update Submitted That Met QC Criteria

May 13, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 92-0382
  • NCI-V94-0506 (Other Grant/Funding Number: National Cancer Institute)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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