A Phase I Study of Bi-Weekly rBBX-01 in Patients With Solid Tumors
NCT ID: NCT00869388
Last Updated: 2013-07-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
12 participants
INTERVENTIONAL
2008-10-31
2009-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1
rBBX-01 1.0 mg/m2 SC on 5 consecutive days on weeks 1, 3, 5, and 7
rBBX-01
Arm 2
rBBX-01 2.0 mg/m2 SC on 5 consecutive days on weeks 1, 3, 5, and 7
rBBX-01
Arm 3
rBBX-01 4.0 mg/m2 SC on 5 consecutive days on weeks 1, 3, 5, and 7
rBBX-01
Arm 4 (optional)
rBBX-01 8.0 mg/m2 SC on 5 consecutive days on weeks 1, 3, 5, and 7
rBBX-01
Interventions
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rBBX-01
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Premal Thaker, M.D.
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Washington University School of Medicine
St Louis, Missouri, United States
Countries
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References
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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. doi: 10.1158/1078-0432.CCR-05-2423.
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. doi: 10.1177/00912709922008191.
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. doi: 10.1002/ijc.20801.
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.
Related Links
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Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Other Identifiers
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08-0961
Identifier Type: -
Identifier Source: org_study_id
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