Clinical trial NCT00869388: A Phase I Study of Bi-Weekly rBBX-01 in Patients With Solid Tumors
Official title: A Phase I Study of Bi-Weekly rBBX-01 in Patients With Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumors
Keywords: malignant
resistant
solid tumor
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2009-03-26
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: To determine the dose limiting toxicity and safety of bi-weekly courses of rBBX-01 in patients with resistant solid tumor malignancies.
timeFrame: Four bi-weekly 5 day courses
Secondary outcomes:
measure: 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.
timeFrame: 4 bi-weekly 5 day courses
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Premal Thaker, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.1177/00912709922008191.
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. doi: 10.1002/ijc.20801.
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.