A Phase I Dose Escalation Study of SGN-35 Alone and in Combination With Gemcitabine for CD30-Positive Malignancies

This study is currently recruiting participants.

Verified by Seattle Genetics, Inc., April 2009

First Received: March 27, 2008 Last Updated: April 9, 2009 History of Changes

Sponsored by:	Seattle Genetics, Inc.
Information provided by:	Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:	NCT00649584

Purpose

This study will examine the safety profile of SGN-35 alone and in combination with gemcitabine. The study will test increasing doses of SGN-35 given weekly to small groups of patients.

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

MedlinePlus related topics: Cancer Lymphoma

Drug Information available for: Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	A Phase I Dose Escalation Study of SGN-35 Alone and in Combination With Gemcitabine in Patients With Relapsed/Refractory CD30-Positive Hematologic Malignancies

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

Primary Outcome Measures:

Incidence of adverse events and laboratory abnormalities. [ Time Frame: 1 month after last dose ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

PK profile [ Time Frame: 2 months after last dose ] [ Designated as safety issue: No ]
Immunogenicity (anti-SGN-35 antibodies) [ Time Frame: 1 month after last dose ] [ Designated as safety issue: Yes ]
Anti-tumor activity [ Time Frame: 1 month after last dose ] [ Designated as safety issue: No ]

Estimated Enrollment:	72
Study Start Date:	March 2008
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental SGN-35 alone or in combination with gemcitabine.	Drug: SGN-35 IV; 0.4 up to 1.8 mg/kg; weekly 3 out of 4 weeks; minimum of two 28-day cycles Drug: gemcitabine IV, 1000 mg/m2 weekly 3 out of 4 weeks

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically confirmed CD30-positive hematologic malignancy.
Patients with HL must have failed systemic chemotherapy.
Patients with other CD30-positive malignancies (including ALCL) must be beyond first remission or refractory to front line chemotherapy.
Patients must have measurable disease of at least 1.5 cm as documented by radiographic technique.

Exclusion Criteria:

Current diagnosis of primary cutaneous ALCL (systemic ALCL eligible).
History of allogeneic stem cell transplant.
Patients who have had previous treatment with any anti-CD30 antibody.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00649584

Contacts

Contact: Terri Lowe

866-333-SGEN

clinicaltrials@seagen.com

Locations

United States, Alabama
University of Alabama at Birmingham	Recruiting
Birmingham, Alabama, United States, 35294
Contact: Jeanne Connor 205-975-2944 jeanne.connor@ccc.uab.edu
Principal Investigator: Andres Forero-Torres, MD
United States, California
Stanford University Medical Center	Recruiting
Stanford, California, United States, 94305
Contact: Euodia Jonathan 650-725-6432 euodia@stanford.edu
Principal Investigator: Sandra Horning, MD
United States, Florida
University of Miami	Recruiting
Miami, Florida, United States, 33136
Contact: Francine Coleman 305-243-8226 fcoleman@med.miami.edu
Principal Investigator: Joseph Rosenblatt, MD
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, Texas
University of Texas - MD Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Contact: Mary Joy Liboon 713-792-2860 mjliboon@mdanderson.org
Principal Investigator: Michelle Fanale, MD

Sponsors and Collaborators

Seattle Genetics, Inc.

Investigators

Study Director:

Dana Kennedy, PharmD

Seattle Genetics, Inc.

More Information

No publications provided

Responsible Party:	Seattle Genetics, Inc ( Dana Kennedy, Assistant Medical Director )
Study ID Numbers:	SG035-0002
Study First Received:	March 27, 2008
Last Updated:	April 9, 2009
ClinicalTrials.gov Identifier:	NCT00649584 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Seattle Genetics, Inc.:

Antigens, CD30
Antibody-Drug Conjugate
Antibodies, Monoclonal
Monomethyl Auristatin E
Combined Modality Therapy
Drug Therapy

Immunotherapy
Lymphoma, Non-Hodgkin
Disease, Hodgkin
Lymphoma, Large-Cell, Anaplastic
Hematologic Diseases
Lymphoma

Study placed in the following topic categories:

Antimetabolites
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Immunologic Factors
Hodgkin Lymphoma, Adult
Hematologic Diseases
Hodgkin's Disease
Immunosuppressive Agents
Antiviral Agents
Antibodies, Monoclonal
Lymphoma, B-Cell
Lymphatic Diseases

Antibodies
Radiation-Sensitizing Agents
B-cell Lymphomas
Lymphoma, T-Cell
Lymphoma, Large-Cell, Anaplastic
Gemcitabine
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma, Large-cell
Lymphoma
Hodgkin Disease
Immunoglobulins

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Lymphoma, B-Cell
Lymphoma, T-Cell
Therapeutic Uses
Lymphoma, Large-Cell, Anaplastic
Gemcitabine
Lymphoma
Hodgkin Disease

Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Neoplasms by Histologic Type
Immune System Diseases
Enzyme Inhibitors
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Lymphatic Diseases
Neoplasms
Radiation-Sensitizing Agents
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin

ClinicalTrials.gov processed this record on May 07, 2009