Status:
COMPLETED
A Phase I Study of Bi-Weekly rBBX-01 in Patients With Solid Tumors
Lead Sponsor:
Washington University School of Medicine
Conditions:
Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study will evaluate toxicity associated with escalating doses of rBBX-01 given bi-weekly to patients with solid tumors.
Eligibility Criteria
Inclusion
- Confirmed metastatic or unresectable, resistant solid tumor. Gynecologic tumors preferred.
- 18 years and above
- GOG performance status greater than or equal to 2
- Life expectancy greater than 6 months
- Acceptable organ and marrow function
- Willingness to agree to use adequate contraception prior to study entry and for the duration of study participation
Exclusion
- Chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or have not recovered from adverse events due to agents administered more than 4 weeks earlier
- Not receiving any other investigational agents
- Known brain metastasis
- Uncontrolled intercurrent illness including, but not limited to ongoing ore active infection, symptomatic congestive heart failure, unstable angina pectoris,cardiac arrythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnancy
- Immunosuppression including subjects with known HIV infection on immunosuppressive drugs or having an autoimmune disorder
- Penicillin allergy
- Symptomatic prostate hypertrophy
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00869388
Start Date
October 1 2008
End Date
December 1 2009
Last Update
July 15 2013
Active Locations (1)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110