A Safety Study of SGN-40 in Patients With Non-Hodgkin's Lymphoma

This study has been completed.
Sponsor:
Collaborator:
Genentech
Information provided by:
Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:
NCT00103779
First received: February 14, 2005
Last updated: June 7, 2013
Last verified: October 2011
  Purpose

This is an open-label, multi-dose, Phase I, dose escalation study to define the safety profile and preliminary anti-tumor activity of SGN-40 in patients with refractory or recurrent non-Hodgkin B-cell lymphomas.


Condition Intervention Phase
Non-Hodgkin Lymphoma
Drug: SGN-40 (anti-huCD40 mAb)
Phase 1

Seattle Genetics, Inc. has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I, Multi-Dose Study of SGN-40 (Anti-huCD40 mAb) in Patients With Non-Hodgkin's Lymphoma

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Adverse events and lab abnormalities. [ Designated as safety issue: Yes ]

Enrollment: 50
Study Start Date: December 2004
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: SGN-40 (anti-huCD40 mAb)
1 mg/kg IV (in the vein) on Day 1; 1-2 mg/kg IV on Day 4; 2-4 mg/kg IV on Day 8; 3-8 mg/kg on Days 15, 22 and 29.
Other Name: dacetuzumab

Detailed Description:

A minimum of 3 patients will be entered into each dose-level cohort for 5 weeks. A dose-escalation schema will be employed in cohorts. The initial dose starts at 1 mg/kg on Day 1 and 4 followed by 2mg/kg on Day 8. Dose escalation will occur on weeks 3-5 with a maximum weekly dose of 8 mg/kg. Patients who meet criteria of at least partial response will be eligible for additional 4 weekly doses at highest dose tolerated.

  Eligibility

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

Inclusion Criteria:

  • Patients must have a histological diagnosis of B cell non-Hodgkin's lymphoma, including diffuse large B-cell, mantle cell, follicular, small lymphocytic, and marginal zone lymphoma by the World Health Organization criteria.
  • Patients must have an archived paraffin or fresh tumor specimen available for immunohistologic evaluation of CD40, CD20, & CD79a.
  • Patients must have relapsed lymphoma and must have failed frontline chemotherapy.
  • Patients who have not received autologous stem cell transplant must have refused or be ineligible for it.
  • Patients must have completed radiotherapy, chemotherapy, and/or treatment with investigational anti-cancer agents 4 weeks prior to registration. Patients must have completed any monoclonal antibody treatment, including rituximab, 6 months prior to registration.
  • Patients must have completed autologous bone marrow transplant 4 months prior to registration.
  • Patient must have at least one site of measurable disease defined by unidimensional lesion ≥ 2 cm by conventional CT scan.
  • Patients must have an ECOG performance status ≤ 2 and a life expectancy > 3 months.
  • Patients must have the following required baseline laboratory data:

    • Platelet count ≥ 75,000/mm3,
    • Hemoglobin ≥ 9.0 g/dL,
    • Absolute neutrophil count ≥ 1,250/mm3,
    • ALT/AST ≤ 2.5 times ULN,
    • Total bilirubin ≤ 1.5 times ULN,
    • Creatinine < 1.5 mg/dL,
  • Females of childbearing potential must have a negative serum β-hCG pregnancy test result within 3 days prior to the first dose of SGN-40 and must agree to use an effective contraceptive method during the course of the study and for 6 months following the last dose of study drug.
  • If a deep venous thrombosis or other vascular even has required medical or surgical intervention in the past year, patients must either be on stable dose of anticoagulant therapy for at least 3 weeks or have completed anticoagulant therapy at least 3 months prior to registration with radiographic confirmation that thrombosis is resolved.
  • Patients must be at least 18 years of age.
  • Patients must be available for periodic blood sampling, study-related assessments and management of toxicity at the treating institution.

Exclusion Criteria:

  • Patients with history or clinical evidence of leptomeningeal or central nervous system (CNS) lymphoma.
  • Patients with a documented history within 6 months of registration of a cerebral vascular event, myocardial infarction, deep venous thrombosis or other vascular event that has required medical or surgical intervention. Patients must have completed anticoagulant therapy at least 3 months prior to registration. Prophylactic anticoagulant therapy for indwelling catheters is acceptable.
  • Patients who have received an allogeneic stem cell transplant.
  • Patients who have had major surgery within 4 weeks prior to registration.
  • Patients with a known hypersensitivity to recombinant proteins or any excipient contained in the drug formulation.
  • Patients with a history of another primary malignancy that has not been in remission for at least 5 years (non-melanoma skin cancer and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on PAP smear are exempt from the five year limit).
  • Patients with any active systemic viral, bacterial, or fungal infection within four weeks prior to registration.
  • Patients with known positivity for HIV, hepatitis B or hepatitis C infection.
  • Patients with a history of significant chronic or recurrent infections requiring treatment.
  • Patients with a history of migraines or severe headaches requiring medical therapy within 12 months of enrollment.
  • Patients on systemic steroids who have not been on a stable daily dose (not exceeding 10 mg prednisone or equivalent) during 4 weeks prior to the first dose of SGN 40.
  • Patients who are pregnant or breastfeeding.
  • Patients with any serious underlying medical condition that would impair their ability to receive or tolerate the planned treatment.
  • Patients with dementia or altered mental status that would preclude the understanding and/or rendering of informed consent.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00103779

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, California
Stanford University
Stanford, California, United States, 94305
United States, Florida
University of Miami
Miami, Florida, United States, 33136
United States, New York
Cornell University
New York, New York, United States, 10029
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Seattle Genetics, Inc.
Genentech
Investigators
Study Director: Jonathan Drachman, MD Seattle Genetics, Inc.
  More Information

Additional Information:
Publications:
Responsible Party: Jonathan Drachman, MD, Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT00103779     History of Changes
Other Study ID Numbers: SG040-0002
Study First Received: February 14, 2005
Last Updated: June 7, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Seattle Genetics, Inc.:
Antigens, CD40
Antibody, Monoclonal
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Hematologic Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on April 20, 2014