Completed

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

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What is being tested

13-cis retinoic acid

+ 13-cis retinoic acid

+ Tocopherol

DrugDietary Supplement
Who is being recruted

Bronchial Neoplasms+10

+ Carcinoma, Bronchogenic

+ Lung Diseases

From 18 to 90 Years
+16 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Phase 2
Interventional
Study Start: January 1993
See protocol details

Summary

Principal SponsorUniversity of Colorado, Denver
Last updated: May 15, 2020
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 1993

Actual date on which the first participant was enrolled.

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.

NCT00002586
Principal SponsorUniversity of Colorado, Denver
Last updated: May 15, 2020
Sourced from a government-validated database.Claim as a partner

Protocol

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

96 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 90 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bronchial NeoplasmsCarcinoma, BronchogenicLung DiseasesNeoplasmsNeoplasms by SiteRespiratory Tract DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsChemically-Induced DisordersCarcinoma, Non-Small-Cell LungLung NeoplasmsSmall Cell Lung CarcinomaDrug-Related Side Effects and Adverse Reactions

Criteria

7 inclusion criteria required to participate
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
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 be a current smoker or ex-smoker who have not smoked for at least 6 months more
Patients must have adequate hepatic function with bilirubin < 1.5 mg % and SGPT < 4 times institutional upper limits of normal
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9 exclusion criteria prevent from participating
Chest x-ray must not show evidence of tumor
Patients must have no serious intercurrent illness including insulin dependent diabetes mellitus or hypercholesterolemia ( > 239mg/dl) / hypertriglyceridemia ( > 149mg/dl)
Patients must not be taking tetracycline or minocycline
Patients must not be taking vitamin A or E supplements
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
13-cis retinoic acid 50 mg/d

Group II

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

Group III

No Intervention
Observation

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 4 locations

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

Denver, United StatesOpen University of Colorado Cancer Center at University of Colorado Health Sciences Center in Google Maps

National Jewish Center for Immunology and Respiratory Medicine

Denver, United States

Lung Cancer Institute

Denver, United States

Veterans Affairs Medical Center - Denver

Denver, United States
Completed4 Study Centers