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 18 and over NCI UTHSC-8565011093 NCI-T85-0276W, T85-0276

Objectives

I.  Determine the maximum tolerated dose of deoxyspergualin administered by 
120-hour continuous infusion every 28 days in patients with cancer.
II.  Determine the qualitative and quantitative toxicities and reversibility 
of toxicity of deoxyspergualin administered in this fashion.
III.  Determine the pharmacokinetic parameters of deoxyspergualin administered 
on this schedule.
IV.  Collect any information concerning the antitumor effects of 
deoxyspergualin.
V.  Determine the recommended dose of deoxyspergualin administered on this 
schedule for initial Phase II therapeutic trials.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients 18 years of age or older 
with a histologically proven solid neoplasm who are not candidates for or 
failures on known regimens or protocols of higher efficacy or priority; 
patients with leukemia are not eligible.  Measurable disease is desirable, but 
not required.  Patients must not have received cytotoxic chemotherapy for at 
least 3 weeks prior to study entry or must have recovered from the toxic 
effects of that therapy.  A performance status of 3 or better and a life 
expectancy of at least 12 weeks are required, as is adequate bone marrow, 
liver, and renal function (i.e., peripheral WBC of at least 3,000, segmented 
plus unsegmented absolute granulocytes of at least 1,500, platelets of at 
least 100,000, total bilirubin no more than 1.5 mg%, alkaline phosphatase and 
SGOT no more than 2 times normal, creatinine no more than 2.0 mg%, creatinine 
clearance at least 50 ml/minute, and normal urinalysis).  Atrial fibrillation, 
a history of myocardial infarction, ventricular ectopy, and angina exclude, as 
does a history of cerebrovascular accident.  Women of childbearing potential 
are not eligible; a pregnancy test is required before study entry, and 
patients should use appropriate birth control measures.  Patients with a 
history of active gastrointestinal bleeding, duodenal ulcers, or gastritis in 
the past 3 months are not eligible.

Expected Enrollment

At least 3 patients will be entered at each dose level; at least 6 patients 
will be entered at the minimal toxic dose and the maximum tolerated dose.  A 
total of 39-42 patients are expected to be entered.  As of April 1989, 50 
patients have been entered, and 6 additional patients will be entered at 2 
dose levels.

Outline

Nonrandomized study.
Single-agent Chemotherapy.  Deoxyspergualin, DSG, NSC-356894.

Trial Contact Information

Trial Lead Organizations

University of Texas Health Science Center at San Antonio

Geoffrey Weiss, MD, Protocol chair(Contact information may not be current)		Ph: 210-567-4777 Email: weiss@uthscsa.edu