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Phase I Study of N-Acetylcysteine (NAC) in Patients at Increased Risk of Malignancy (Summary Last Modified 12/93)

Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase I Prevention Closed over 18 RPMI-DS-9101
NCI-P92-0023

Objectives

I.  Establish the safety and side effects of prolonged administration of 
N-acetylcysteine (NAC) in patients with an increased risk of malignancy.

II.  Study the pharmacokinetics of NAC when given in low doses over an 
extended period.

III.  Evaluate the biological effects of this agent on plasma and 
intracellular glutathione.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:


--Population Characteristics--

Individuals with no evidence of disease but at increased risk
for malignancy due to the following factors:
  Family history of malignancy
  Premalignant condition
  Other predisposing factors

Age:
  Over 18

Performance status:
  ECOG 0 or 1

Hematopoietic:
  WBC at least 4,000
  Platelets at least 100,000
  Hct at least 35%

Hepatic:
  Bilirubin no greater than 1.4 mg/dl
  SGOT no greater than 75 IU/liter

Renal:
  Creatinine no greater than 1.5 mg/dl

Other:
  No pregnant women
  Effective contraception required of fertile women

Expected Enrollment

Approximately 25 subjects will be accrued.  A total period of  15 months 
(treatment and follow-up) is anticipated.

Outline

Nonrandomized study.

Chemoprevention.  N-Acetylcysteine, NAC, NSC-111180.

Trial Contact Information

Trial Lead Organizations

Roswell Park Cancer Institute

Patrick Creaven, MBBS, PhD, Protocol chair
Ph: 716-845-8451; 800-685-6825
Email: patrick.creaven@roswellpark.org

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.