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

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