| Inclusion Criteria: | 1) Patients must have a histological diagnosis of Hodgkin Lymphoma (HL) or Anaplastic Large Cell Lymphoma (ALCL) (non-cutaneous).
2) Pts must provide tumor tissue for confirmation of histologic diagnosis and assessment of CD30 expression in tumor tissue. Archived paraffin embedded samples are acceptable for pts. If pt has had multiple biopsies, the original biopsy for diagnosis, and most recent biopsy are requested. Pts who have previously received anti-CD30 txt, the best biopsy for analysiss of CD30 antigen expression is the specimen collected after anti-CD30 txt.
3) (#2 continued) If no archival specimens are available, pt will be asked to voluntarily consent for another biopsy; however, if tissue cannot be obtained due to size, location, contraindication, or pt refusal, the pt will remain eligible to participate in study.
4) Patients must have received two or more prior therapeutic regimens, one of which should include hematopoietic cell transplant, either autologous or allogeneic transplant. a. If a hematopoietic cell transplant was refused, or the patient was not eligible to receive a transplant, the patient is still eligible to participate in the trial if the patient has received two or more prior chemotherapy based regimens.
5) (Continued from Inclusion #4) b. Patients who have received allogeneic transplant must not have relapsed less than 6 months after their transplant and they must be at least 200 days post-transplant prior to enrollment. Additionally, there must be no evidence of graft-versus-host disease (GVHD) and the patient must be stable without immunosuppressive treatment, including systemic corticosteroids (per os [po] or iv), for > 3 months prior to enrollment.
6) Patients who have previously received any targeted anti-CD30 therapies are eligible provided that the therapy was completed at least 6 months prior to enrollment, there is no residual toxicity (see Inclusion Criteria #2 above for biopsy requirements). Additionally, these patients must be negative for anti-XmAb2513 antibodies.
7) Patients must be able to receive outpatient treatment and follow-up at the treating institution.
8) Patients should have at least one radiographically measurable site of disease of >/= 1.5 cm in the largest dimension. a. If there is only one site of disease and its longest diameter is from 1.5 to 2.0 cm radiographically, there must be evidence of clinically active disease by either positive FDG-PET imaging or by biopsy of the site of disease prior to enrollment.
9) Patients must have completed all anti-cancer treatment (e.g. immunosuppressive medications, antineoplastic therapy, vaccination, chemotherapy, and radiation therapy) > 4 weeks prior to enrollment. Patients who have received a hematopoietic cell transplant must have completed immunosuppressive treatment, including systemic corticosteroids (po or iv), for > 3 months prior to enrollment.
10) Patients must be >/= 18 years of age.
11) Female patients capable of reproduction, and male patients who have partners capable of reproduction, must agree to use an effective contraceptive method during the course of the study and 2 months following the completion of their last treatment. Females of childbearing potential must have a negative beta human chorionic gonadotropin (Beta-hCG) pregnancy test result within 3 days prior to first study dose. Female patients who are surgically sterilized or who are > 45 years old and have not experienced menses for > 2 years may have the Beta-hCG pregnancy test waived.
12) Required baseline laboratory data: Platelet count >/= 80,000/mm^3 (patients must not be platelet transfusion-dependent as evidenced by maintenance of platelet count above 50,000/mm^3 in the 28 days prior to enrollment without transfusion) ; Absolute neutrophil count >/= 1,500/mm^3 ; Creatinine </= 1.5 times ULN ; ALT (SGPT) /AST (SGOT) </= 2.5 times upper limit of normal (ULN) ; Total bilirubin </= 1.5 times ULN
13) Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
14) Patients must give written informed consent. A copy of the signed informed consent form will be retained in the patient's chart.
15) Patients must have completed any palliative corticosteroid therapy (e.g. for management of Type B symptoms) > 2 weeks prior to enrollment. |