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Phase I Study of Aprotinin in Advanced Breast Cancer

NCT00354900 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2009-08-04

No results posted yet for this study

Summary

There is an intimate relationship between processes which promote growth, invasion, and metastasis of cancers, and processes which regulate blood clotting. The enzymes uPA and PAI-1 are key regulators of the remodeling of recently formed blood clots, and there is substantial information linking greater levels of uPA and PAI-1 in breast cancers with a greater likelihood of breast cancer recurrence and death. As uPA and PAI-1 are excellent markers for a cancer's aggressive clinical behavior, uPA and PAI-1 may be potential targets for anticancer therapy. Aprotinin is an inhibitor of uPA activation, and has been approved by the FDA to reduce blood loss in patients undergoing cardiopulmonary bypass surgery. Studies in animals and limited studies in patients have shown that Aprotinin slows the growth of tumors. Our hypothesis is that uPA is chronically activated in malignancies, and that inhibition of uPA by Aprotinin would slow the rate of progression of breast cancer.

Conditions

Interventions

DRUG

Aprotinin

Sponsors & Collaborators

  • Dartmouth-Hitchcock Medical Center

    lead OTHER

Principal Investigators

  • Gary N Schwartz, MD · Norris Cotton Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-07-31
Completion
2007-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00354900 on ClinicalTrials.gov