Search / Trial NCT00002586

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

Launched by UNIVERSITY OF COLORADO, DENVER · Jan 26, 2003

Trial Information

Current as of December 07, 2024

Completed

Keywords

Non Small Cell Lung Cancer Small Cell Lung Cancer Drug/Agent Toxicity By Tissue/Organ

ClinConnect Summary

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.
...

Gender

ALL

Eligibility criteria

  • 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

Trial Officials

York E. Miller, MD

Principal Investigator

University of Colorado, Denver

About University Of Colorado, Denver

The University of Colorado, Denver, is a leading academic institution dedicated to advancing medical research and improving healthcare outcomes. With a strong emphasis on innovation and collaboration, the university conducts a diverse range of clinical trials aimed at addressing critical health challenges. Its research initiatives are supported by a multidisciplinary team of experts, state-of-the-art facilities, and a commitment to ethical standards and patient safety. By fostering partnerships with local and global communities, the University of Colorado, Denver, strives to translate scientific discoveries into meaningful advancements in clinical practice and public health.

Locations

Denver, Colorado, United States

Denver, Colorado, United States

Denver, Colorado, United States

Denver, Colorado, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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