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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over NCI ICC-83H2 NCI-T83-0924D, T83-0924

Objectives

I.  Determine the antitumor activity of 2-aminothiadiazole (ATDA) used as a 
single agent in patients with advanced non-Hodgkin's lymphoma.
II.  Evaluate the toxicity of ATDA.
III.  Determine whether there is any difference in response to ATDA in 
patients previously treated with five or fewer chemotherapeutic agents vs. 
those previously treated with more than five agents.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients at least 18 years of age 
with measurable non-Hodgkin's lymphoma of one of the following histologies:  
diffuse poorly differentiated lymphocytic, diffuse mixed 
lymphocytic/histiocytic, diffuse histiocytic, nodular histiocytic, diffuse 
undifferentiated, and diffuse unclassifiable.  Patients must have failed on or 
relapsed after at least one combination chemotherapy regimen.  CNS lesions are 
not considered measurable lesions.  The ECOG performance status must be 2 or 
better, the expected survival must be at least 60 days, and there must be 
adequate bone marrow, liver, and kidney function.  There may be no gout or 
history of gout (including gouty nephropathy), and hyperuricemic patients must 
have serum uric acid normalized by allopurinol treatment prior to entry.  
Patients must be free from acute or chronic infection and off all antibiotics 
for at least 1 week prior to entry, and patients may not have inflammatory 
bowel disease or be taking nicotinamide.  There may have been no radiotherapy 
within 28 days (none at any time to indicator lesions), and at least 28 days 
must have elapsed since prior chemotherapy (42 days for nitrosoureas).

Expected Enrollment

Nineteen patients in each stratification category will receive at least the 
minimum treatment.  As of June 1989, no additional patients will be treated at 
the original starting dose (125 mg/sqm); 15 additional patients will be 
treated at a starting dose of 175 mg/sqm.

Outline

Nonrandomized study.
Single-agent Chemotherapy.  2-Aminothiadiazole, ATDA, NSC-4728.

Trial Contact Information

Trial Lead Organizations

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Daniel Shevrin, MD, Protocol chair(Contact information may not be current)		Ph: 312-908-5250