| Exclusion Criteria: | 1) If a patient is positive for ANY of the following exclusion criteria, the patient will not be eligible for retreatment in this study: Withdrew consent to participate in any prior SGN-35 study.
2) Congestive heart failure, Class III or IV, by the New York Heart Association criteria.
3) History of another primary malignancy that has not been in remission for at least 3 years. (The following are exempt from the 3-year limit: nonmelanoma skin cancer, curatively treated localized prostate cancer, and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on PAP smear.)
4) Patients with acute or chronic graft-versus-host disease (GvHD) or receiving immunosuppressive therapy as treatment for or prophylaxis against GvHD.
5) Known cerebral/meningeal disease, including history of progressive multifocal leukoencephalopathy (PML).
6) Any active viral, bacterial, or fungal infection requiring treatment with antimicrobial therapy within 2 weeks prior to the first dose of SGN-35 in this study. Routine antimicrobial prophylaxis is acceptable. For HIV-positive patients, concurrent highly active antiretroviral therapy (HAART) is acceptable.
7) Current therapy with other systemic antineoplastic (with the exception of corticosteroids) or investigational agents.
8) Women who are pregnant or lactating.
9) Patients with known hypersensitivity to any excipient (trehalose, sodium citrate, or polysorbate 80) contained in the drug formulation.
10) Patients with dementia or an altered mental state that would preclude the understanding and rendering of informed consent.
11) Patients < 100 days from allogeneic transplant.
12) Post-allogeneic transplant patients with any detectable level of cytomegalovirus (CMV) by polymerase chain reaction (PCR). Prior PCR positivity that was successfully treated is acceptable provided the baseline PCR result is negative prior to first dose of study drug.
13) Prior donor lymphocyte infusion <8 weeks prior to first dose of study drug.
14) If a patient is positive for ANY of the following exclusion criteria, the patient will not be eligible for extension treatment in this study: Withdrew consent to participate in any prior SGN-35 study.
15) Unable to receive first infusion of SGN-35 in this study between 21 - 28 days of last dose in the prior study, unless a dosing delay of up to 3 weeks is warranted for toxicity.
16) Current therapy with other systemic antineoplastic (with the exception of corticosteroids) or investigational agents.
17) Women who are pregnant or lactating.
18) Patients with a known hypersensitivity to any excipient contained in the drug formulation.
19) Post-allogeneic transplant patients must have documented CMV quantitation by PCR. If a patient has detectable levels of CMV, permission to enter the study must be granted by the Medical Monitor. |