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

Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00869388
• Other study ID #: 08-0961
• Status: Completed
• Phase: Phase 1
• First received: March 25, 2009
• Last updated: July 12, 2013
• Start date: October 2008
• Est. completion date: December 2009

Study information

• Verified date: July 2013
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Solid Tumors

Intervention

Biological:
• rBBX-01

Locations

Country	Name	City	State
United States	Washington University School of Medicine	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (4)

Basche M, Gustafson DL, Holden SN, O'Bryant CL, Gore L, Witta S, Schultz MK, Morrow M, Levin A, Creese BR, Kangas M, Roberts K, Nguyen T, Davis K, Addison RS, Moore JC, Eckhardt SG. A phase I biological and pharmacologic study of the heparanase inhibitor PI-88 in patients with advanced solid tumors. Clin Cancer Res. 2006 Sep 15;12(18):5471-80. — View Citation

Hayashi N, Kinoshita H, Yukawa E, Higuchi S. Pharmacokinetic and pharmacodynamic analysis of subcutaneous recombinant human granulocyte colony stimulating factor (lenograstim) administration. J Clin Pharmacol. 1999 Jun;39(6):583-92. — View Citation

Rader JS, Aylsworth CF, Juckett DA, Mutch DG, Powell MA, Lippmann L, Dimitrov NV. Phase I study and preliminary pharmacology of the novel innate immune modulator rBBX-01 in gynecologic cancers. Clin Cancer Res. 2008 May 15;14(10):3089-97. doi: 10.1158/1078-0432.CCR-07-4250. — View Citation

Rosenberg B, Juckett DA, Aylsworth CF, Dimitrov NV, Ho SC, Judge JW, Kessel S, Quensen J, Wong KP, Zlatkin I, Zlatkin T. Protein from intestinal Eimeria protozoan stimulates IL-12 release from dendritic cells, exhibits antitumor properties in vivo and is correlated with low intestinal tumorigenicity. Int J Cancer. 2005 May 1;114(5):756-65. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the dose limiting toxicity and safety of bi-weekly courses of rBBX-01 in patients with resistant solid tumor malignancies.		Four bi-weekly 5 day courses	Yes
Secondary	To evaluate the pharmacokinetic and pharmacodynamics of bi-weekly rBBX-01. To correlate the inter-patient sensitivity to rBBX-01 with in vitro studies on patient blood. To describe any anti-tumor activity of rBBX-01.		4 bi-weekly 5 day courses	No

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine