Status:
COMPLETED
Study of SGN-30 (Antibody) in Patients With Refractory or Recurrent Anaplastic Large Cell Lymphoma
Lead Sponsor:
Seagen Inc.
Conditions:
Anaplastic Large-Cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 (H...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
End Date :
December 1 2006
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00079755
Start Date
February 1 2004
End Date
December 1 2006
Last Update
December 18 2014
Active Locations (18)
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1
University of Alabama, Birmingham
Birmingham, Alabama, United States, 35294-3300
2
University of Califorinia at Los Angeles
Los Angeles, California, United States, 91342
3
Georgetown University
Washington D.C., District of Columbia, United States, 20007
4
University of Miami
Miami, Florida, United States, 33136