Anaplastic Large Cell Lymphoma Clinical Trial
Official title:
A Phase II Study of SGN-30 in Combination With CHOP in Anaplastic Large Cell Lymphoma
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
PRIMARY OBJECTIVES:
I. Determine the efficacy of monoclonal antibody SGN-30 in combination with
cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (CHOP) in patients
with newly diagnosed anaplastic large cell lymphoma (ALCL).
II. Determine the safety of combining monoclonal antibody SGN-30 with CHOP chemotherapy.
SECONDARY OBJECTIVES:
I. Determine whether monoclonal antibody SGN-30 can induce apoptosis of ALCL cells in vivo.
II. Determine the response duration in patients treated with this regimen.
III. Correlate response with pretreatment serum CD30 levels.
IV. Determine response to single-agent monoclonal antibody SGN-30.
OUTLINE: This is a multicenter study. Patients are stratified according to anaplastic large
cell kinase (ALK) status (positive vs negative).
Monoclonal antibody SGN-30 monotherapy: Patients receive monoclonal antibody SGN-30 IV over
2 hours once weekly for 3 weeks.
Monoclonal antibody SGN-30 and CHOP chemotherapy: Beginning 1 week after completion of
monoclonal antibody SGN-30 monotherapy, patients receive monoclonal antibody SGN-30 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
in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for at least 5
years.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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