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

The Washington University

Status and phase: Completed; Phase 1

Conditions: Solid Tumors

Treatments: Biological: rBBX-01

Study type: Interventional

Funder types: Other

Identifiers

NCT00869388

08-0961

Details and patient eligibility

About

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

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 4 patient groups

Arm 1

Experimental group

Description:

rBBX-01 1.0 mg/m2 SC on 5 consecutive days on weeks 1, 3, 5, and 7

Treatment:

Biological: rBBX-01

Arm 2

Experimental group

Description:

rBBX-01 2.0 mg/m2 SC on 5 consecutive days on weeks 1, 3, 5, and 7

Treatment:

Biological: rBBX-01

Arm 3

Experimental group

Description:

rBBX-01 4.0 mg/m2 SC on 5 consecutive days on weeks 1, 3, 5, and 7

Treatment:

Biological: rBBX-01

Arm 4 (optional)

Experimental group

Description:

rBBX-01 8.0 mg/m2 SC on 5 consecutive days on weeks 1, 3, 5, and 7

Treatment:

Biological: rBBX-01