Brentuximab Vedotin in Patients With CD30-positive Nonlymphomatous Malignancies
NCT ID: NCT01461538
Last Updated: 2016-03-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
84 participants
INTERVENTIONAL
2011-10-31
2014-12-31
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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Brentuximab vedotin 1.8 mg/kg
Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
brentuximab vedotin
1.8 mg/kg every 3 weeks by intravenous (IV) infusion
Brentuximab vedotin 2.4 mg/kg
Brentuximab vedotin 2.4 mg/kg every 3 weeks by IV infusion
brentuximab vedotin
2.4 mg/kg every 3 weeks by intravenous (IV) infusion
Brentuximab vedotin 1.2 mg/kg
Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by IV infusion
brentuximab vedotin
1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion
Interventions
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brentuximab vedotin
1.8 mg/kg every 3 weeks by intravenous (IV) infusion
brentuximab vedotin
2.4 mg/kg every 3 weeks by intravenous (IV) infusion
brentuximab vedotin
1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have failed, refused, or have been deemed ineligible for standard therapy
* Measurable disease
* Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 or a Karnofsky or Lansky Performance Status score greater than or equal to 70
Exclusion Criteria
* History of another primary invasive malignancy that has not been definitively treated or in remission for at least 3 years
* Evidence of active cerebral/meningeal disease
6 Years
ALL
No
Sponsors
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Seagen Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Neil Josephson, MD
Role: STUDY_DIRECTOR
Seagen Inc.
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
City of Hope
Duarte, California, United States
PMK Medical Group Inc., DBA Ventura County Hematology Oncology Specialists
Oxnard, California, United States
Rocky Mountain Cancer Centers - Aurora
Aurora, Colorado, United States
Mayo Clinic Cancer Center
Jacksonville, Florida, United States
Ocala Oncology Center
Ocala, Florida, United States
Indiana University Simon Cancer Center
Indianapolis, Indiana, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Minnesota Oncology Hematology P.A.
Minneapolis, Minnesota, United States
New York Oncology Hematology, P.C.
Albany, New York, United States
University Hospitals Case Medical Center
Cleveland, Ohio, United States
Willamette Valley Cancer and Research / USOR
Eugene, Oregon, United States
Northwest Cancer Specialists, P.C.
Tulatin, Oregon, United States
St. Francis Hospital
Greenville, South Carolina, United States
Texas Oncology - Bedford
Bedford, Texas, United States
Texas Oncology - Medical City Dallas
Dallas, Texas, United States
Texas Oncology - Dallas Presbyterian
Dallas, Texas, United States
Texas Oncology Denton South
Denton, Texas, United States
Texas Oncology - Fort Worth 12th Avenue
Fort Worth, Texas, United States
MD Anderson Cancer Center / University of Texas
Houston, Texas, United States
MD Anderson Cancer Center Leukemia Group
Houston, Texas, United States
Texas Oncology - Central Austin Cancer Center
Round Rock, Texas, United States
Cancer Centers of South Texas - HOAST
San Antonio, Texas, United States
Texas Oncology - Waco
Waco, Texas, United States
Oncology and Hematology Assoc of SW VA DBA Blue Ridge Cancer Care
Blacksburg, Virginia, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States
Puget Sound Cancer Centers
Edmonds, Washington, United States
Cancer Care Northwest
Spokane Valley, Washington, United States
Yakima Valley Memorial Hospital / North Star Lodge
Yakima, Washington, United States
Countries
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References
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Albany C, Einhorn L, Garbo L, Boyd T, Josephson N, Feldman DR. Treatment of CD30-Expressing Germ Cell Tumors and Sex Cord Stromal Tumors with Brentuximab Vedotin: Identification and Report of Seven Cases. Oncologist. 2018 Mar;23(3):316-323. doi: 10.1634/theoncologist.2017-0544. Epub 2017 Dec 8.
Borate U, Mehta A, Reddy V, Tsai M, Josephson N, Schnadig I. Treatment of CD30-positive systemic mastocytosis with brentuximab vedotin. Leuk Res. 2016 May;44:25-31. doi: 10.1016/j.leukres.2016.02.010. Epub 2016 Feb 27.
Giannatempo P, Paolini B, Miceli R, Raggi D, Nicolai N, Fare E, Catanzaro M, Biasoni D, Torelli T, Stagni S, Piva L, Mariani L, Salvioni R, Colecchia M, Gianni AM, Necchi A. Persistent CD30 expression by embryonal carcinoma in the treatment time course: prognostic significance of a worthwhile target for personalized treatment. J Urol. 2013 Nov;190(5):1919-24. doi: 10.1016/j.juro.2013.04.057. Epub 2013 Apr 25.
Other Identifiers
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SGN35-013
Identifier Type: -
Identifier Source: org_study_id
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