Trial to Define the Safety and Tolerability of SGN-40, Rituximab, and Gemcitabine in Patients With DLBCL - Full Text View

Sponsor:	Seattle Genetics, Inc.
Collaborator:	Genentech
Information provided by (Responsible Party):	Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:	NCT00655837

Purpose

The purpose of this study is to determine safety and tolerability of combination therapy of SGN-40 with gemcitabine and rituximab for the treatment of lymphoma. This study is also intended to estimate how well your disease responds to this treatment.

Condition	Intervention	Phase
Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin	Drug: SGN-40 Drug: rituximab Drug: gemcitabine	Phase I

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase Ib Study of SGN-40 in Combination With Rituximab and Gemcitabine for the Treatment of Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

Resource links provided by NLM:

MedlinePlus related topics: Lymphatic Diseases Lymphoma

Drug Information available for: Gemcitabine Gemcitabine hydrochloride Rituximab Dacetuzumab

U.S. FDA Resources

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

Primary Outcome Measures:

Determine the safety and adverse-event profile for combination therapy of SGN-40 with gemcitabine and rituximab. [ Time Frame: 10 months from registration of last patient ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Estimate progression free survival, clinical response rates to treatment, and overall survival to determine efficacy. [ Time Frame: Follow-up every 6 weeks after end of treatment. ] [ Designated as safety issue: No ]

Estimated Enrollment:	29
Study Start Date:	April 2008
Study Completion Date:	February 2010
Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: SGN-40 4-12mg/kg IV; Days 1, 4, 8, 15 and 22 of Cycle 1 and Days 1, 8 and 15 of Cycles 2-8. Other Name: dacetuzumab Drug: rituximab 375 mg/m2 IV injection; Days -2, 8, 15 and 22 of Cycle 1 and Day 1 of Cycles 2-8. Other Name: Rituxan Drug: gemcitabine 1000 mg/m2 IV Injection; Days 1 and 15 of all Cycles. Other Name: Gemzar

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Have a histologic diagnosis of DLBCL, including transformed histology and follicular grade 3 disease.
Must have at least one site of biopsy-proven disease demonstrating both of the following: bidimensional measurable disease with the longest axis >= 1.5cm by radiographic imaging or positive FDG-PET scan at baseline.
Patients with DLBCL and who have either relapsed, refractory, or progressive disease following salvage therapy, OR relapsed, refractory, or progressive disease following initial therapy and be medically unfit to receive aggressive therapy.
Either fresh or archived tumor specimen must be available.

Exclusion Criteria:

Documented history within 6 months of registration of a cerebral vascular event, unstable angina, myocardial infarction, or cardiac symptoms.
Patients who have received allogeneic stem cell transplant.
Patients with evidence of another invasive primary malignancy within the past three years other than non-melanoma skin cancer, cervical carcinoma in situ, in situ carcinoma of the breast, or fully resected prostate cancer with normal PSA within 8 weeks of registration.
Patients with any active systemic viral, bacterial, or fungal infection requiring intravenous anti-infectives within 4 weeks prior to first dose of study drug.
Patients with a history or clinical evidence of leptomeningeal or central nervous system (CNS) lymphoma.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00655837

Locations

United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-3300
United States, Arizona
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259
United States, Colorado
University of Colorado
Aurora, Colorado, United States, 80045-0510
United States, Illinois
Oncology Specialists
Park Ridge, Illinois, United States, 60068
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, Nevada
Nevada Cancer Institute
Las Vegas, Nevada, United States, 89135
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

Seattle Genetics, Inc.

Genentech

Investigators

Study Director:

Nancy Whiting, PharmD

Seattle Genetics, Inc.

More Information

No publications provided

Responsible Party:	Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:	NCT00655837 History of Changes
Other Study ID Numbers:	SG040-0008
Study First Received:	April 4, 2008
Last Updated:	October 7, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Seattle Genetics, Inc.:

Antigens, CD40
Antibodies, Monoclonal
Combined Modality Therapy
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Non-Hodgkin

Hematologic Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Lymphoma

Additional relevant MeSH terms:

Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Gemcitabine
Rituximab
Antimetabolites, Antineoplastic

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on February 02, 2012