Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Vitamin E in Preventing the Side Effects of Isotretinoin in Former and Current Smokers Who Are Receiving Isotretinoin to Prevent Lung Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Prevention	Closed	18 and over	NCI	MDA-DM-97078 NCI-P98-0132, NCT00003599

Objectives

I.  Determine whether the addition of alpha-tocopherol (AT; vitamin E) to 
isotretinoin decreases the incidence of Grade II and higher toxicity of 
isotretinoin when administered to former and current smokers.

II.  Determine the compliance rate of isotretinoin of smoker and former 
smokers with or without AT over a six month period.

III.  Determine the feasibility of recruiting former and current smokers with 
or without AT over a six month period.

IV.  Determine the effect of isotretinoin administration on serum retinol and 
retinol-binding protein levels in these patients.

Entry Criteria

Disease Characteristics:

Current smokers with 20+ packs per year history of smoking 

OR

Former smokers who discontinued smoking 1 year prior to registration (less
than 5 cigarettes in the prior year) and had a 20+ packs per year history
prior to discontinuing smoking

Prior/Concurrent Therapy:

Biologic therapy:
 Not specified

Chemotherapy:
 No prior isotretinoin

Endocrine therapy:
 Not specified

Radiotherapy:
 Not specified

Surgery:
 Not specified

Other:
 No prior warfarin or its derivatives
 At least 3 months since megadose vitamin A (greater than 25,000 IU/day) or
  beta-carotene greater than 30 mg/day or alpha-tocopherol at least 400 IU
  daily 
 No concurrent megadose vitamin A (greater than 25,000 IU/day), beta-carotene
  greater than 30 mg/day, alpha-tocopherol at least 400 IU daily, or other
  daily supplements and tonics

Patient Characteristics:

Age:
 18 and over

Performance status:
 Not specified

Life expectancy:
 Not specified

Hematopoietic:
 WBC greater than 3,000/mm3
 Platelet count greater than 100,000/mm3

Hepatic:
 Bilirubin less than 1.5 mg/dL
 SGOT less than 40 IU/mL OR SGPT less than IU/mL

Renal:
 Not specified

Other:
 Fasting triglycerides less than 320 mg/dL
 No prior malignancy in the past 5 years except nonmelanomous skin cancer or
  noninvasive cervical cancer
 No history of malabsorption syndrome
 Not pregnant
 Effective contraception required of all fertile persons

Expected Enrollment

There will be 300 patients (150 per arm) accrued into this study over an 
estimated 9 months.

Outline

This is randomized, placebo controlled study.  Patients are stratified by 
smoking status (current smoker vs former smoker) and age (less than 50 vs 50 
and over).

Patients are randomized to be take alpha-tocopherol (AT) orally and 
isotretinoin orally daily (arm I) or isotretinoin orally plus AT placebo 
orally daily (arm II).  Treatment in each arm continues for 6 months.

Patients are followed at 1, 3, 6, and 7 months from start of treatment.

Trial Contact Information

Trial Lead Organizations

M. D. Anderson Cancer Center at University of Texas

Rodger Winn, MD, Protocol chair		Ph: 713-792-3715; 800-392-1611 Email: rwinn@mdanderson.org

Registry Information
Official Title		A Randomized Study of the Effect of Alpha-tocopherol (AT) on 13-cis-retinoic acid (13-cRA) Toxicity in a Preliminary Chemoprevention Trial in Former and Current Smokers
Registered in ClinicalTrials.gov		NCT00003599
Date Submitted to PDQ		1998-09-25
Information Last Verified		2007-05-21

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