SGN-30 and Combination Chemotherapy in Treating Patients With Newly Diagnosed Anaplastic Large Cell Lymphoma
|Anaplastic Large Cell Lymphoma||Drug: Cyclophosphamide Drug: Doxorubicin hydrochloride Drug: vincristine sulfate Drug: prednisone Drug: SGN-30||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase II Study of SGN-30 in Combination With CHOP in Anaplastic Large Cell Lymphoma|
- Objective Response Rate (ORR) [ Time Frame: Up to 5 years ]Objective response rate (ORR) defined as the proportion of participants experiencing a Complete Response (CR) or Partial Response to a regimen of SGN-3- + CHOP using International Workshop Response Criteria (IWG) for Non-Hodgkin's Lymphomas (NHL). The IWG criteria (Cheson et al 2007) for a CR is a complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. A PR is at least a 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses, no increase should be observed in the size of other nodes, liver or spleen, and no new sites of disease should be observed.
|Study Start Date:||August 2006|
|Study Completion Date:||May 2010|
|Primary Completion Date:||May 2010 (Final data collection date for primary outcome measure)|
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.
Given IV 750 mg/m^2 day 1
Other Names:Drug: Doxorubicin hydrochloride
Given 50 mg/m^2 IV day 1
Other Names:Drug: vincristine sulfate
Given 1.4 mg/m^2 IV
Other Names:Drug: prednisone
100 mg orally daily days 1 - 5
Other Names:Drug: SGN-30
12 mg/kg weekly IV over 2 hours once weekly for 3 weeks.
Other Name: Monoclonal antibody SGN-30 monotherapy
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00365274
|United States, Texas|
|M D Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Michelle Fanale, MD||UT MD Anderson Cancer Center|