A Phase I Dose Escalation Study of SGN-35 Alone and in Combination With Gemcitabine for CD30-Positive Malignancies

A Phase I Dose Escalation Study of Weekly SGN-35 Monotherapy and in Combination With Gemcitabine in Patients With Relapsed/Refractory CD30-positive Hematologic Malignancies

This study will examine the safety profile of SGN-35 alone and in combination with gemcitabine. The study will test increasing doses of SGN-35 given weekly to small groups of patients.

Inclusion Criteria:

• Histologically confirmed CD30-positive hematologic malignancy.
• Patients with HL must have failed systemic chemotherapy.
• Patients with other CD30-positive malignancies (including ALCL) must be beyond first remission or refractory to front line chemotherapy.
• Patients must have measurable disease of at least 1.5 cm as documented by radiographic technique.

Exclusion Criteria:

• Current diagnosis of primary cutaneous ALCL (systemic ALCL eligible).
• History of allogeneic stem cell transplant.
• Patients who have had previous treatment with any anti-CD30 antibody.