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This study will evaluate toxicity associated with escalating doses of rBBX-01 given bi-weekly to patients with solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | rBBX-01 1.0 mg/m2 SC on 5 consecutive days on weeks 1, 3, 5, and 7 |
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| Arm 2 | Experimental | rBBX-01 2.0 mg/m2 SC on 5 consecutive days on weeks 1, 3, 5, and 7 |
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| Arm 3 | Experimental | rBBX-01 4.0 mg/m2 SC on 5 consecutive days on weeks 1, 3, 5, and 7 |
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| Arm 4 (optional) | Experimental | rBBX-01 8.0 mg/m2 SC on 5 consecutive days on weeks 1, 3, 5, and 7 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rBBX-01 | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Premal Thaker, M.D. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17000682 | Background | 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. | |
| 10354962 |
| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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| Background |
| 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. |
| 15609305 | Background | 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. |
| 18483376 | Background | 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. |