| Inclusion Criteria: | 1) Patients must have a histologically confirmed CD30-positive hematologic malignancy (i.e. Hodgkin's lymphoma, anaplastic large cell lymphoma (ALCL), Kaposi's sarcoma, cutaneous T-cell lymphomas, diffuse large B-cell lymphoma, some follicular lymphomas). Immunohistochemistry or flow cytometry may be performed on either original diagnostic biopsy material or biopsy of relapsed disease. a. Tissue must be available to Seattle Genetics for confirmation of CD30 expression via slides or tumor block when requested. b. Anaplastic lymphoma kinase (ALK) status should be documented for ALCL patients.
2) Patients with HL must have failed systemic chemotherapy either as induction therapy for advanced stage disease or salvage therapy after initial radiotherapy for early stage disease and were ineligible for, refused treatment by or previously received stem cell transplant. Patients with other CD30-positive malignancies (including ALCL) must be beyond first remission or refractory to front line chemotherapy.
3) Patients must have bi-dimensional measurable disease of at least 1.5 cm as documented by radiographic technique (spiral CT preferred).
4) Patients must have completed (and recovered from treatment-related toxicities) any prior treatment with radiotherapy, chemotherapy, biologics, immunotherapy and/or treatment with other investigational anti-cancer agents at least 4 weeks prior to first study dose.
5) Patients must have completed any prior treatment with nitrogen mustard agents, melphalan, or BCNU (Bischloroethylnitrosourea; Carmustine) therapy at least 6 weeks prior to first study dose.
6) Patients must have received any prior autologous hematopoietic stem cell infusion at least 8 weeks prior to first study dose.
7) Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
8) Patients must have adequate pulmonary function, defined as a corrected DL CO>/=70%.
9) Patients must be greater than or equal to 12 years of age.
10) Patient must have the following required baseline laboratory data: a. Absolute neutrophil count greater than or equal to 1,500/uL. b. Platelet count greater than or equal to 100,000/uL. c. Serum bilirubin level less than or equal to 1.5 x upper limits of normal (ULN). d. Serum creatinine less than or equal to 1.5 x ULN. e. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) less than or equal to 2.5 x ULN.
11) Patients must be available for periodic blood sampling, study-related assessments and management of toxicity at the treating institution and be willing to comply with the expected drug administration schedule.
12) Females of childbearing potential must have a negative serum or urine Beta-hCG pregnancy test result within 3 days prior to the first dose of SGN-35 and must agree to use an effective contraceptive method during the study and for 6 months following the last dose of study drug. Females of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy.
13) 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.
14) Patients or their legally authorized representative must provide written informed consent. |