SGN-30 and Combination Chemotherapy in Treating Patients With Newly Diagnosed Anaplastic Large Cell Lymphoma
Anaplastic Large Cell Lymphoma
About this trial
This is an interventional treatment trial for Anaplastic Large Cell Lymphoma focused on measuring non-Hodgkin's lymphoma, NHL, murine monoclonal antibody, mAb, SGN-30, CHOP, Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine, Prednisone, anaplastic large cell lymphoma, Lymphoma, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin, Lymphoma, Large-Cell, Anaplastic, Neoplasms by Histologic Type, Neoplasms, Lymphoproliferative Disorders, Lymphatic Diseases, Immunoproliferative Disorders, Immune System Diseases, Lymphoma, B-Cell, Lymphoma, T-Cell, Antibodies, Antibodies, Monoclonal, Immunologic Factors, Physiological Effects of Drugs, Pharmacologic Actions, Immunosuppressive Agents, Antirheumatic Agents, Therapeutic Uses, Antineoplastic Agents, Alkylating, Alkylating Agents, Molecular Mechanisms of Pharmacological Action, Antineoplastic Agents, Myeloablative Agonists, Antibiotics, Antineoplastic
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed systemic anaplastic large cell lymphoma (ALCL) Tissue available for the determination of anaplastic large cell kinase (ALK) status [t(2;5), ALK-NPM translocation] prior to study entry Prior steroids or topical treatments are allowed. Patients who are on chronic steroid therapy may receive concomitant steroids provided they have been on a stable dosage for at least 3 months prior to enrollment Measurable disease, defined as >= 1 lesion that can be accurately measured in >= 1 dimension (longest diameter to be recorded) as >= 20 mm by conventional techniques or as >= 10 mm by spiral CT scan The Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 OR Karnofsky PS 70-100% White Blood Count (WBC) >= 3,000/mm³ Absolute neutrophil count >= 1,500/mm³ Platelet count >= 100,000/mm³ (unless due to lymphoma [i.e., splenomegaly and/or bone marrow involvement]) Bilirubin =< 1.5 times upper limit of normal (ULN) AST or ALT =< 2.5 times ULN Creatinine =< 1.5 times ULN (unless due to lymphoma) OR creatinine clearance >=60 mL/min Left ventricular ejection fraction (LVEF) >= 50% Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after completion of study treatment Exclusion Criteria: No rapidly progressing disease or bulky disease, defined as a mass of > 7 cm in largest diameter No primary cutaneous ALCL No known brain metastases No concurrent combination antiretroviral therapy for HIV-positive patients No history of allergic reactions attributed to compounds of similar chemical or biological composition to monoclonal antibody SGN-30 No uncontrolled intercurrent illness, including, but not limited to, any of the following: Ongoing or active infection Symptomatic congestive heart failure Unstable angina pectoris Cardiac arrhythmia Psychiatric illness or social situations that would preclude study compliance No prior or other concurrent malignancy with < 90% probability of survival at 5 years No other concurrent anticancer agents or therapies No prior chemotherapy for ALCL No other concurrent investigational agents
Sites / Locations
- M D Anderson Cancer Center
Arms of the Study
Arm 1
Experimental
SGN-30 + Combination Chemotherapy
Monoclonal antibody SGN-30 monotherapy: SGN-30 12 mg/kg weekly intravenously(IV) over 2 hours once weekly for 3 weeks. SGN-30 and CHOP chemotherapy: Beginning 1 week after completion of monoclonal antibody SGN-30 monotherapy, SGN-30 12 mg/kg IV over 2 hours on day 1 and CHOP chemotherapy comprising cyclophosphamide IV over 1 hour, doxorubicin hydrochloride IV over 15 minutes, and vincristine IV over 15 minutes on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for 6-8 courses.