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

December 17, 2014 updated by: Seagen Inc.

A Phase I, Multi-Dose Study of SGN-40 (Anti-huCD40 mAb) in Patients With Non-Hodgkin's Lymphoma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
    • California
      • Stanford, California, United States, 94305
        • Stanford University
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami
    • New York
      • New York, New York, United States, 10029
        • Cornell University
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • dacetuzumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Adverse events and lab abnormalities.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seagen Inc.

Collaborators

Genentech, Inc.

Investigators

  • Study Director: Jonathan Drachman, MD, Seagen Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Primary Completion (Actual)

March 1, 2007

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

February 14, 2005

First Submitted That Met QC Criteria

February 14, 2005

First Posted (Estimate)

February 15, 2005

Study Record Updates

Last Update Posted (Estimate)

December 18, 2014

Last Update Submitted That Met QC Criteria

December 17, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SG040-0002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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