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

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