A Phase I Study of Bi-Weekly rBBX-01 in Patients With Solid Tumors

A Phase I Study of Bi-Weekly rBBX-01 in Patients With Solid Tumors

This study will evaluate toxicity associated with escalating doses of rBBX-01 given bi-weekly to patients with solid tumors.

Inclusion Criteria:

• 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 Criteria:

• 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