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	any age	NCI	WSU-A-53284 NCI-T84-0197W, T84-0197

Objectives

I.  Determine the maximum tolerated dose of acodazole in patients with 
refractory malignancies.
II.  Assess the toxicity of acodazole when given intravenously every 21 days.
III.  Observe for antitumor activity of acodazole.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients of any age with 
histologically confirmed advanced malignant solid tumors that are refractory 
to first- or second-line chemotherapy and not amenable to surgery and/or 
radiotherapy, or for which no standard chemotherapy exists.  Disease must be 
measurable or evaluable.  Four weeks must have elapsed since prior 
radiotherapy or cytotoxic chemotherapy (6 weeks for mitomycin-C and 
nitrosoureas) and patients must have recovered from all toxicities of such 
therapy.  Concomitant radiotherapy to areas of measurable disease renders 
these sites unevaluable for response; concomitant cranial radiotherapy for 
brain metastases is allowed.  A performance status of 3 or better (30-100% 
Karnofsky) and adequate hematologic function are required.  Adequate renal 
function defined as a BUN less than 25 mg/dl and a serum creatinine level less 
than 2.0 mg/dl, and adequate hepatic function defined as bilirubin less than 
2.0 mg/dl and SGOT and SGPT less than 2 times the upper limits of normal, are 
required.  (For patients with serum creatinine or total bilirubin between 2-5 
mg/dl, the following eligibility criteria will be used:  if 3 patients have 
been entered and are evaluable at a given dose level, then a patient with a 
serum creatinine or total bilirubin of 2-5 mg/dl may be entered at that dose 
level).

Expected Enrollment

Approximately 30 patients will be accrued.  Per February 1986 notice, patient 
entry has been curtailed pending further study of the cardiotoxicity of 
Acodazole in a dog model.

Outline

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

Trial Contact Information

Trial Lead Organizations

Barbara Ann Karmanos Cancer Institute

Richard Pazdur, MD, Protocol chair		Ph: 301-594-2473