Study of SGN-30 (Antibody) in Patients With Refractory or Recurrent Anaplastic Large Cell Lymphoma

This study has been completed.
Sponsor:
Information provided by:
Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:
NCT00079755
First received: March 12, 2004
Last updated: June 7, 2013
Last verified: October 2011
  Purpose

To investigate safety and antitumor activity of SGN-30 in patients with Hodgkin's Disease and anaplastic large cell lymphoma (ALCL).

As of March 22, 2005, interim analysis of the Hodgkin's Disease (HD) arm has been completed per the statistical plan in the protocol. SG030-0003 is now closed to further recruitment of HD patients.


Condition Intervention Phase
Anaplastic Large-Cell Lymphoma
Drug: SGN-30 (anti-CD30 mAb)
Phase 2

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: A Phase II Multi-Dose Study of SGN-30 (Anti-CD30 mAb) in Patients With Refractory or Recurrent Hodgkin's Disease or Anaplastic Large Cell Lymphoma

Resource links provided by NLM:


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

Estimated Enrollment: 80
Study Start Date: February 2004
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Detailed Description:

SGN-30 is the chimeric form of a novel murine monoclonal antibody (mAb), AC-10, that has specificity for CD30. The CD30 antigen has a very low expression on normal cells, but is expressed on malignant cells in Hodgkins disease and anaplastic large cell lymphoma.

This study is designed to define the toxicity profile and antitumor activity of SGN-30 in patients with refractory or recurrent Hodgkin's disease and with refractory or recurrent anaplastic large cell lymphoma. Patients will receive 6 weekly intravenous (IV) infusions of SGN-30 followed by a 4 week observation period.

  Eligibility

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

Inclusion Criteria:

  • Patients must have refractory or recurrent HD or refractory or recurrent ALCL.
  • Patients must have histologically confirmed CD30+ HD or ALCL.
  • Patients must have bidimensional measurable disease on physical examination or radiologic evaluation.
  • Patients must have failed systemic chemotherapy either as initial therapy for advanced disease or as salvage therapy after initial radiotherapy for early stage disease.
  • Patients may have received no more than four treatments (radiation, chemotherapy, and/or biologics) prior to enrollment.
  • Patients may have received no more than one stem cell transplantation.
  • Patients who have undergone stem cell transplantation must have received at least one therapy post-transplantation. Patients who have not had stem cell transplantation must be considered ineligible or refuse treatment by stem cell transplantation.
  • Patients must have completed radiotherapy and/or chemotherapy at least four weeks prior to enrollment. Any prior treatment with nitrogen mustard agents, melphalan, or BCNU must have been completed at least six weeks prior to enrollment.
  • Patients must have an ECOG performance status of ≤ 2 and a life expectancy > three months.
  • 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.
  • Females of childbearing potential must have a negative β-HCG pregnancy test result within three days of enrollment. All patients must agree to use an effective contraceptive method during the course of the study.
  • Patients must give written informed consent. A copy of the signed informed consent form will be retained in the patient's chart.
  • Patients must meet baseline lab data requirements.

Exclusion Criteria:

  • Patients with primary cutaneous ALCL
  • Patients who have been treated previously with any anti-CD30 antibody
  • Patients who have received any mAb unless a recent serum testing reveals no antibody titer and no evidence of human anti-murine antibodies (HAMA) or human anti-chimeric antibodies (HACA) in the peripheral circulation
  • Patients receiving any investigational biological agent within eight weeks of enrollment or any other investigational agent within four weeks of enrollment
  • Patients with a known hypersensitivity to recombinant proteins or any excipient contained in the drug formulation
  • Patients with a history of other malignancies during the past five years with the exception of adequately treated basal or squamous cell skin cancer or cervical carcinoma in situ
  • Patients with known active viral, bacterial, or systemic fungal infection; patients who are known to be HIV, Hepatitis B, or Hepatitis C positive.
  • Patients with symptomatic cardiac disease including ventricular dysfunction, coronary artery disease, or arrhythmias
  • Patients with symptomatic brain metastases requiring treatment
  • 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 understanding and rendering of informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00079755

Locations
United States, Alabama
University of Alabama, Birmingham
Birmingham, Alabama, United States, 35294-3300
United States, California
University of Califorinia at Los Angeles
Los Angeles, California, United States, 91342
United States, District of Columbia
Georgetown University
Washington, District of Columbia, United States, 20007
United States, Florida
University of Miami
Miami, Florida, United States, 33136
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Maryland
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, Nebraska
University of Nebraska
Omaha, Nebraska, United States, 68198-7680
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Cornell University
New York, New York, United States, 10021
University of Rochester
Rochester, New York, United States, 14642
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Oregon
Oregon Health Science University
Portland, Oregon, United States, 97239
Kaiser Permanente
Portland, Oregon, United States, 97227
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Washington
University of Washington
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Seattle Genetics, Inc.
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00079755     History of Changes
Obsolete Identifiers: NCT00107133
Other Study ID Numbers: SG030-0003
Study First Received: March 12, 2004
Last Updated: June 7, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Seattle Genetics, Inc.:
Anaplastic Large-Cell Lymphoma
Lymphoma
antigens, CD30
Monoclonal Antibody

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

ClinicalTrials.gov processed this record on August 18, 2014