SGN-30 and Combination Chemotherapy in Treating Patients With Newly Diagnosed Anaplastic Large Cell Lymphoma
Condition: Anaplastic Large Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, Large-Cell, Anaplastic
Intervention: Cyclophosphamide; Doxorubicin hydrochloride; vincristine sulfate; prednisone; SGN-30
Intervention description: Given IV 750 mg/m^2 day 1; Given 50 mg/m^2 IV day 1; Given 1.4 mg/m^2 IV; 100 mg orally daily days 1 - 5; 12 mg/kg weekly IV over 2 hours once weekly for 3 weeks.
Intervention MeSH terms: Prednisone; Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Vincristine; Brentuximab Vedotin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: 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

Summary:

      This phase II trial is studying how well giving SGN-30 together with combination chemotherapy
      works in treating patients with newly diagnosed anaplastic large cell lymphoma. Monoclonal
      antibodies, such as SGN-30, can block cancer growth in different ways. Some block the ability
      of cancer cells to grow and spread. Others find cancer cells and help kill them or carry
      cancer-killing substances to them. Drugs used in chemotherapy work in different ways to stop
      the growth of cancer cells, either by killing the cells or by stopping them from dividing.
      Giving SGN-30 together with combination chemotherapy may kill more cancer cells
    

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