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

Purpose

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

Condition	Intervention	Phase
Solid Tumors	Biological: rBBX-01	Phase 1

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase I Study of Bi-Weekly rBBX-01 in Patients With Solid Tumors

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:

To determine the dose limiting toxicity and safety of bi-weekly courses of rBBX-01 in patients with resistant solid tumor malignancies. [ Time Frame: Four bi-weekly 5 day courses ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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. [ Time Frame: 4 bi-weekly 5 day courses ] [ Designated as safety issue: No ]

Estimated Enrollment:	18
Study Start Date:	October 2008
Study Completion Date:	December 2009
Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Minimum 3 patients receive 1.0 mg/m2 s.c on 5 consecutive days on weeks 1,3,5, and 7.

Minimum 3 patients receive 2.0 mg/m2 s.c on 5 consecutive days on weeks 1,3,5, and 7.

Minimum 3 patients receive 4.0 mg/m2 s.c on 5 consecutive days on weeks 1,3,5, and 7.

Optional: Minimum 3 patients receive 8.0 mg/m2 s.c on 5 consecutive days on weeks 1,3,5, and 7.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00869388

Locations

United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110

Sponsors and Collaborators

Washington University School of Medicine

Investigators

Principal Investigator:

Janet Rader, MD

Washington University School of Medicine

More Information

Additional Information:

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Publications:

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.

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.

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.

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.

Responsible Party:	Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT00869388 History of Changes
Other Study ID Numbers:	08-0961
Study First Received:	March 25, 2009
Last Updated:	October 6, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Washington University School of Medicine:

malignant
resistant
solid tumor

Additional relevant MeSH terms:

Neoplasms

ClinicalTrials.gov processed this record on May 16, 2013