Study of SGN-30 (Antibody) in Patients With Refractory or Recurrent Anaplastic Large Cell Lymphoma
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
1 other identifier
interventional
80
1 country
18
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2004
Typical duration for phase_2
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2004
CompletedFirst Submitted
Initial submission to the registry
March 12, 2004
CompletedFirst Posted
Study publicly available on registry
March 16, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedDecember 18, 2014
December 1, 2014
2.8 years
March 12, 2004
December 17, 2014
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seagen Inc.lead
Study Sites (18)
University of Alabama, Birmingham
Birmingham, Alabama, 35294-3300, United States
University of Califorinia at Los Angeles
Los Angeles, California, 91342, United States
Georgetown University
Washington D.C., District of Columbia, 20007, United States
University of Miami
Miami, Florida, 33136, United States
Northwestern University
Chicago, Illinois, 60611, United States
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, 21201, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
University of Nebraska
Omaha, Nebraska, 68198-7680, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Cornell University
New York, New York, 10021, United States
University of Rochester
Rochester, New York, 14642, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Kaiser Permanente
Portland, Oregon, 97227, United States
Oregon Health Science University
Portland, Oregon, 97239, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
University of Washington
Seattle, Washington, 98109, United States
Related Publications (2)
Wahl AF, Klussman K, Thompson JD, Chen JH, Francisco LV, Risdon G, Chace DF, Siegall CB, Francisco JA. The anti-CD30 monoclonal antibody SGN-30 promotes growth arrest and DNA fragmentation in vitro and affects antitumor activity in models of Hodgkin's disease. Cancer Res. 2002 Jul 1;62(13):3736-42.
PMID: 12097283RESULTForero-Torres A, Leonard JP, Younes A, Rosenblatt JD, Brice P, Bartlett NL, Bosly A, Pinter-Brown L, Kennedy D, Sievers EL, Gopal AK. A Phase II study of SGN-30 (anti-CD30 mAb) in Hodgkin lymphoma or systemic anaplastic large cell lymphoma. Br J Haematol. 2009 Jul;146(2):171-9. doi: 10.1111/j.1365-2141.2009.07740.x. Epub 2009 May 19.
PMID: 19466965RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 12, 2004
First Posted
March 16, 2004
Study Start
February 1, 2004
Primary Completion
December 1, 2006
Study Completion
December 1, 2006
Last Updated
December 18, 2014
Record last verified: 2014-12