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

Completed · Phase 2

Conditions studied: Anaplastic Large-Cell Lymphoma

In brief

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.

Key facts

Study ID

NCT00079755

Run by

Seagen Inc.

People needed

80

Starts

2004-02-01

Expected to finish

2006-12-01

Last updated by the study team

2014-12-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• University of Alabama, Birmingham — Birmingham, Alabama, United States
• University of Califorinia at Los Angeles — Los Angeles, California, United States
• Georgetown University — Washington D.C., District of Columbia, United States
• University of Miami — Miami, Florida, United States
• Northwestern University — Chicago, Illinois, United States
• University of Maryland Greenebaum Cancer Center — Baltimore, Maryland, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• University of Nebraska — Omaha, Nebraska, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• Cornell University — New York, New York, United States
• University of Rochester — Rochester, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Kaiser Permanente — Portland, Oregon, United States
• Oregon Health Science University — Portland, Oregon, United States
• University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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