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Pilot Phase I-II Evaluation of Human Fibroblast Interferon for Disseminated Breast Cancer

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

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase II, Phase I


Treatment


Closed


no age specified





MDA-MBDT-7866


Objectives

I.  Determine the toxicity and pharmacology of fibroblast interferon in breast 
cancer patients.
II.  Evaluate the possible therapeutic efficacy of fibroblast interferon in 
patients with metastatic breast cancer.
III.  Determine the immunological effects of fibroblast interferon.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients with histologically proven 
metastatic breast cancer confined to lung and/or soft tissue regions, who have 
failed first-line chemotherapy and are not potentially curable.  Patients must 
have a limited life expectancy, at least 50% of normal pulmonary function, or 
more than 25% of pulmonary area involved with tumor and they must not have had 
a pneumonectomy.  Patients must have adequate cardiac function.

Expected Enrollment

Protocol closed 09/80.

Outline

Nonrandomized study.
Single-agent Immunotherapy.  Human fibroblast Interferon.

Trial Contact Information

Trial Lead Organizations

M. D. Anderson Cancer Center at University of Texas

Eugene M. McKelvey, MD, Protocol chair
Ph: 713-792-2570; 800-392-1611

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.

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