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Phase II Chemotherapy with L-Alanosine for Patients with Metastatic Carcinoma of the Breast Refractory to Standard Therapy

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

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase II

Treatment

Closed

no age specified

NCI

SWOG-8304

Objectives

I.  Determine the response rate and duration of response among patients with 
metastatic refractory breast carcinoma treated with L-alanosine on a 3-day q 3 
weeks schedule.
II.  Determine the nature and degree of toxicity of L-alanosine in these 
patients.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients with measurable or evaluable 
metastatic carcinoma of the breast resistant to standard therapy and not 
eligible for higher priority SWOG protocols.  The life expectancy must be at 
least 9 weeks and the performance status 2 or better, with the exception that 
patients with a functional class of 3 due to bone pain only will be eligible.  
Liver, kidney, and bone marrow function must be adequate, and patients must 
have recovered from the acute toxicities of any previous therapy.  
Radiotherapy may be given concomitantly to painful areas, brain metastases, or 
lytic bone lesions in danger of fracture provided large areas of bone marrow 
or the measurable lesions are not irradiated.

Expected Enrollment

If there is a response among any of the first 14 evaluable patients in each of 
the two prior chemotherapy stratification groups, accrual will be continued to 
30-40 evaluable patients in that group.  Protocol closed May 1984 with accrual 
objectives met.

Outline

Nonrandomized study.
Single-agent Chemotherapy.  L-Alanosine, NSC-153353.

Published Results

Von Hoff DD, Green SJ, Neidhart JA, et al.: Phase II study of l-alanosine (NSC 153353) in patients with advanced breast cancer: a Southwest Oncology Group study. Invest New Drugs 9(1): 87-88, 1991.

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Charles Coltman, MD, Protocol chair(Contact information may not be current)
Ph: 210-567-2710

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.