Clinical trial NCT00365274
Conditions: Anaplastic Large Cell Lymphoma
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
Sponsor: National Cancer Institute (NCI)
Start date: 2006-08-01; Completion date: 2010-05-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief 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

Detailed description:
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.

Arms: arm 1: 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.
Interventions: intervention 1: Cyclophosphamide intervention 2: Doxorubicin hydrochloride intervention 3: vincristine sulfate intervention 4: prednisone intervention 5: SGN-30
Intervention descriptions: intervention 1: Given IV 750 mg/m\^2 day 1 intervention 2: Given 50 mg/m\^2 IV day 1 intervention 3: Given 1.4 mg/m\^2 IV intervention 4: 100 mg orally daily days 1 - 5 intervention 5: 12 mg/kg weekly IV over 2 hours once weekly for 3 weeks.

Protocol documents: