Project Details


Although only 5% of women with breast cancer present with metastatic
disease, it is estimated that nearly 40% of all patients will eventually
manifest distant dissemination. Given an anticipated breast cancer
incidence of 175,000 new cases in 1991, improvements in metastatic
treatment are urgently needed. Estrogen and progesterone receptor positive tumors can be palliated
effectively by hormonal treatments but eventually breast tumors become
hormone insensitive and require chemotherapy. Chemotherapy is active in
this disease but responses are incomplete and generally last less than one
year. Current concepts regarding the mechanisms involved in the
progression of disease following appropriate endocrine maneuvers suggest
the development of an autonomous growth status, independent of estrogen,
possibly controlled by several autocrine growth factors. Suramin is a new
antitumor compound which chemically represents a highly charged anionic
polymer due to the presence of sulfonic acid groups on too naphthalene
rings. Among various possible mechanisms, this drug is known to suppress
the action of various growth factors such as PDGF, bFGF, TGF-alpha and
beta. Suramin has been shown to have activity in prostate cancer in
studies conducted at the UMCC using a unique pharmacologically guided
program. To extend this observation, the current proposal plans to test
this drug in a phase II trial in breast cancer targeting a drug plasma
concentration of 150-250 micro-g/ml, a level found to be active in our
phase I study in prostate cancer with acceptable toxicity. Eligible women
must have measurable disease and must be hormone refractory if ER or PR
positive. They may have received no more than one chemotherapy regimen for
metastatic disease. We will further extend our study of the
pharmacokinetic and pharmacodynamic behavior of Suramin using adaptive
control with feedback and carefully monitoring the toxicities of this agent
in this new patient population. An initial cohort of 15 patients will be
evaluated with the intent to treat a total of 25 patients if responses are
Effective start/end date9/30/922/28/94


  • National Institutes of Health


  • Medicine(all)

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