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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Closed	over 18	NCI	OSU-83HO125 NCI-T83-1163W, T83-1163

Objectives

I.  Determine the therapeutic response to acodazole in a group of patients 
with advanced malignancy who have no better therapeutic alternative.
II.  Determine the parameters and characteristics of drug toxicity, including 
organ-specific toxicity and characterization of toxicity by predictability, 
reversibility, time course, and dose-response relationships, and determine the 
maximum tolerated dose.
III.  Recommend a Phase II starting dose for this agent.
IV.  Determine the pharmacokinetic behavior of acodazole and correlate it with 
clinical data in selected patients.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients over 18 years of age with 
histologically proven advanced solid tumors that are refractory to all known 
effective therapies and investigational agents of higher potential efficacy.  
Patients should have near normal hepatic, renal, and bone marrow function; the 
life expectancy must be at least 4 weeks.  Patients should have a functional 
capacity of 0 or 1 to be eligible to be treated at the maximum tolerated 
dosage.  Patients must be beyond the period of expected toxicity from prior 
anticancer therapy; those patients who have previously received more than one 
Phase I or II investigational agent are eligible only with the approval of the 
principal investigator.

Expected Enrollment

3 patients will be entered at each dose level; at least 6 patients will be 
treated at the MTD.  Protocol temporarily closed, November 1984, due to 
toxicity.  Protocol closed March 1985.

Outline

Nonrandomized Phase I study.
Single-agent Chemotherapy.  Acodazole, NSC-305884.

Trial Contact Information

Trial Lead Organizations

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Michael Grever, MD, Protocol chair		Ph: 614-293-8724 Email: michael.greever@osumc.edu