| Inclusion Criteria: | 1) Patients with relapsed or refractory HL who have previously received ASCT. Patients must have received prior ASCT at least 12 weeks (3 months) before the first dose of SGN-35 and completed any prior treatment with radiation, chemotherapy, biologics, and/or other investigational agents at least 4 weeks prior to the first dose of SGN-35. Patients must have completed any prior immunotherapy (e.g., rituximab) or radioisotopic therapy at least 12 weeks prior to the first dose of SGN-35 in the absence of clear disease progression.
2) Histologically-confirmed CD30-positive disease by central review; tissue from the most recent post-diagnostic biopsy of relapsed/refractory disease must be available for confirmation of CD30 expression via slides or tumor block. If such tissue is not available, a fresh biopsy must be obtained.
3) Age greater than or equal to 18 years. Patients of age greater than or equal to 12 years may be enrolled at US sites.
4) Fluorodeoxyglucose (FDG)-avid disease by PET and measurable disease of at least 1.5 cm by spiral CT as assessed by the site radiologist.
5) 5. At least ONE of the following as evidence of relapsed or refractory HL: a) Histologically-documented CD30-positive HL from a biopsy obtained at least 4 weeks subsequent to the most recently delivered prior treatment with radiation, chemotherapy, biologics, immunotherapy and/or other investigational agents. b) Interval tumor growth documented between two successive CT evaluations with the second evaluation occurring at least 4 weeks after delivery of any radiation, chemotherapy, biologics, immunotherapy and/or other investigational agents. (cont'd to #6)
6) (cont'd from #5) c) FDG-avidity by PET in a new tumor mass on CT that is unlikely to have an alternative explanation. d) Recurrent FDG-avidity by PET in a previously identified FDG-avid tumor mass on CT that had become negative. e) FDG-avid tumor mass by PET in conjunction with HL related symptoms (e.g., pruritus, B symptoms (fever, night sweats, or weight loss >10%)), after infectious causes have been excluded.
7) An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
8) The following required baseline laboratory data: absolute neutrophil count (ANC) >/=1000/microL, platelets >/=50,000/microL, bilirubin </=1.5X upper limit of normal (ULN) or </=3X ULN for patients with Gilbert's disease, serum creatinine </=1.5X ULN, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) </=2.5X ULN.
9) Females of childbearing potential must have a negative serum or urine Beta-hCG pregnancy test result within 7 days prior to the first dose of SGN-35. Females of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy.
10) Both females of childbearing potential and males who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for 30 days following the last dose of study drug.
11) Patients or their legally authorized representative must provide written informed consent.
12) Patients with a known hypersensitivity to any excipient contained in the drug formulations. Each vial of the product contains 11.5 mg SGN-35, 161 mg trehalose dihydrate, 12.9 mg sodium citrate dihydrate, 0.48 mg citric acid monohydrate, and 0.37 mg polysorbate 80. |