An SGN-35 Trial for Patients Who Have Previously Participated in an SGN-35 Study - Full Text View

Sponsor:	Seattle Genetics, Inc.
Collaborator:	Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):	Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:	NCT00947856

Purpose

This is a multicenter, open-label study to evaluate the safety and efficacy of treatment with SGN-35 in patients who have previously participated in an SGN-35 study.

Condition	Intervention	Phase
Disease, Hodgkin Lymphoma, Large-Cell, Anaplastic Lymphoma, Non-Hodgkin	Drug: SGN-35	Phase II

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Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Treatment With SGN-35 in Patients With CD30-positive Hematologic Malignancies Who Have Previously Participated in an SGN-35 Study

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lymphoma

U.S. FDA Resources

Further study details as provided by Seattle Genetics, Inc.:

Primary Outcome Measures:

Incidence of adverse events and laboratory abnormalities [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: Yes ]
Best clinical response [ Time Frame: Every 2 to 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Duration of response, progression-free survival, and overall survival [ Time Frame: Every 3 months until death or study closure ] [ Designated as safety issue: No ]
Incidence of antitherapeutic antibodies [ Time Frame: Up to 1 month post last dose ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	125
Study Start Date:	July 2009
Estimated Study Completion Date:	November 2013
Estimated Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 SGN-35	Drug: SGN-35 Every 21 days by intravenous infusion (1.2 or 1.8 mg/kg) Other Name: brentuximab vedotin

Eligibility

Ages Eligible for Study:	6 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Participated in a previous SGN-35 study.
CD30-positive hematologic malignancy.
At a minimum, experienced clinical benefit in the prior SGN-35 study. For retreatment, patients must have previously achieved either complete or partial remission with SGN-35 and experienced disease progression after discontinuing the prior SGN-35 study.

Exclusion Criteria:

Withdrew consent to participate in any prior SGN-35 study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00947856

Contacts

Contact: Terri Lowe

866-333-7436

clinicaltrials@seagen.com

Locations

United States, Alabama
UAB Comprehensive Cancer Center	Recruiting
Birmingham, Alabama, United States, 35294-3300
Contact: Amy Valdmanis 205-975-9481 Amy.Valdmanis@ccc.uab.edu
Principal Investigator: Andres Forero-Torres, MD
United States, California
City of Hope National Medical Center	Recruiting
Duarte, California, United States, 91010
Contact: Melissa Solorzano 626-256-4673 ext 62312 melsolorzano@coh.org
Principal Investigator: Robert Chen, M.D.
Stanford Cancer Center	Recruiting
Stanford, California, United States, 94305
Contact: Anne Wiley 650-725-6432 amwiley@stanford.edu
Principal Investigator: Ranjana Advani, MD
United States, Colorado
Colorado Blood Cancer Institute	Recruiting
Denver, Colorado, United States, 80218
Contact: Juli Murphy 720-754-4890 Juli.Murphy@healthonecares.com
Principal Investigator: Jeffrey Matous, MD
United States, Florida
University of Miami Hospital and Clinics, Miller School of Medicine	Recruiting
Miami, Florida, United States, 33136
Contact: Nicole McCullough 305-243-6809 nshank@med.miami.edu
Principal Investigator: Joseph Rosenblatt, MD
United States, Illinois
Loyola University Medical Center - Cardinal Bernadin Cancer Center	Recruiting
Maywood, Illinois, United States, 60153
Contact: Terri Lowe 866-333-7436 clinicaltrials@seagen.com
Principal Investigator: Scott Smith, M.D.
United States, Indiana
St. Francis Medical Group Oncology & Hematology Specialists	Recruiting
Indianapolis, Indiana, United States, 46237
Principal Investigator: Stephen Eric Rubenstein, MD
United States, Michigan
Karmanos Cancer Institute / Wayne State University	Recruiting
Detroit, Michigan, United States, 48201
Contact: Khushbu Kaulaskar 313-576-9812 kaulaskk@karmanos.org
Principal Investigator: Radhakrishnan Ramchandren, M.D.
United States, Missouri
Washington University School of Medicine	Recruiting
St. Louis, Missouri, United States, 63110
Contact: Sarah Larson 314-362-3257 salarson@dom.wustl.edu
Principal Investigator: Nancy Bartlett, MD
United States, New Jersey
The John Theurer Cancer Center, Hackensack University Medical Center	Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Kelly A. Bussanich 201-996-3277 kbussanich@humed.com
Principal Investigator: Andre Goy, M.D.
United States, New York
New York University Cancer Institute	Recruiting
New York, New York, United States, 10016
Contact: Celeste Rojas 212-263-4428 celeste.rojas@nyumc.org
Principal Investigator: Jasmine Zain, M.D.
United States, Ohio
Nationwide Children's Hospital	Recruiting
Columbus, Ohio, United States, 43205
Contact: Terri Lowe 866-333-7436 clinicaltrials@seagen.com
Principal Investigator: Randy Olshefski, MD
United States, Texas
Baylor University Medical Center	Recruiting
Dallas, Texas, United States, 75246
Contact: Michelle Radcliff 214-818-7198 michelle.radcliff@baylorhealth.edu
Principal Investigator: Robert Brian Berryman, M.D.
MD Anderson Cancer Center / University of Texas	Recruiting
Houston, Texas, United States, 77030-4000
Contact: Toni Hutto 713-792-2860 Thutto@mdanderson.org
Principal Investigator: Michelle Fanale, MD
United States, Washington
Seattle Cancer Care Alliance / University of Washington Medical Center	Recruiting
Seattle, Washington, United States, 98109
Contact: Malcolm Mack 206-288-7031 mmack@seattlecca.org
Principal Investigator: Ajay Gopal, MD
France
Service des Maladies du Sang / Hospital Saint Louis	Recruiting
Paris, France, 75475 Cedex 10
Contact: Stephanie Magne +33 1 42 38 54 21 stephanie.magne@sls.aphp.fr
Principal Investigator: Pauline Brice, M.D.

Sponsors and Collaborators

Seattle Genetics, Inc.

Millennium Pharmaceuticals, Inc.

Investigators

Study Director:

Laurie Grove, PA-C

Seattle Genetics, Inc.

More Information

No publications provided

Responsible Party:	Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:	NCT00947856 History of Changes
Other Study ID Numbers:	SGN35-006
Study First Received:	July 24, 2009
Last Updated:	January 30, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Seattle Genetics, Inc.:

Antibodies, Monoclonal
Antibody-Drug Conjugate
Antigens, CD30
Drug Therapy

Hematologic Diseases
Immunotherapy
Monomethylauristatin E

Additional relevant MeSH terms:

Hodgkin Disease
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Large-Cell, Anaplastic
Neoplasms by Histologic Type
Neoplasms

Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Lymphoma, T-Cell

ClinicalTrials.gov processed this record on February 02, 2012