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Bortezomib and Vorinostat as Maintenance Therapy After Autologous Stem Cell Transplant for Non-Hodgkin Lymphoma

2014-08-27 03:18:46 | BioPortfolio

Summary

RATIONALE: Bortezomib and vorinostat in the laboratory may stop the growth of lymphoma cells and make them more likely to die. Giving bortezomib together with vorinostat after an autologous stem cell transplant may thus kill any lymphoma cells that remain after transplant.

PURPOSE: This phase II trial is studying the side effects and how well bortezomib and vorinostat work in treating patients with non-Hodgkin lymphoma after an autologous stem cell transplant.

Description

PRIMARY OBJECTIVES:

I. Assess toxicities of combining vorinostat and bortezomib as maintenance therapy after ASCT for NHL.

SECONDARY OBJECTIVES:

I. Ability to complete planned therapy. II. Time to disease progression and event-free survival. III. Overall survival.

OUTLINE:

All patients receive carmustine IV over 3 hours on day -7; cytarabine IV twice daily over 3 hours and etoposide IV twice daily over 2 hours on days -6 to -3; and melphalan IV over 30 minutes on day -2. Only patients with CD20+ lymphoma receive additional rituximab IV on days -19 and -12. Patients undergo autologous stem cell transplantation on day 0. Patients then receive bortezomib IV on days 2 and 8 and oral vorinostat once daily on days 1-14 of 28-day cycle. Treatment with bortezomib and vorinostat repeats for total of 12 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed for at least 2 years.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Anaplastic Large Cell Lymphoma

Intervention

rituximab, carmustine, cytarabine, etoposide, melphalan, bortezomib, vorinostat, autologous hematopoietic stem cell transplantation

Location

Fred Hutchinson Cancer Research Center
Seattle
Washington
United States
98109

Status

Recruiting

Source

Fred Hutchinson Cancer Research Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:18:46-0400

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Medical and Biotech [MESH] Definitions

A semisynthetic derivative of PODOPHYLLOTOXIN that exhibits antitumor activity. Etoposide inhibits DNA synthesis by forming a complex with topoisomerase II and DNA. This complex induces breaks in double stranded DNA and prevents repair by topoisomerase II binding. Accumulated breaks in DNA prevent entry into the mitotic phase of cell division, and lead to cell death. Etoposide acts primarily in the G2 and S phases of the cell cycle.

Congener of CYTARABINE that is metabolized to cytarabine and thereby maintains a more constant antineoplastic action.

An alkylating nitrogen mustard that is used as an antineoplastic in the form of the levo isomer - MELPHALAN, the racemic mixture - MERPHALAN, and the dextro isomer - MEDPHALAN; toxic to bone marrow, but little vesicant action; potential carcinogen.

A pyrimidine nucleoside analog that is used mainly in the treatment of leukemia, especially acute non-lymphoblastic leukemia. Cytarabine is an antimetabolite antineoplastic agent that inhibits the synthesis of DNA. Its actions are specific for the S phase of the cell cycle. It also has antiviral and immunosuppressant properties. (From Martindale, The Extra Pharmacopoeia, 30th ed, p472)

A murine-derived monoclonal antibody and ANTINEOPLASTIC AGENT that binds specifically to the CD20 ANTIGEN and is used in the treatment of LEUKEMIA; LYMPHOMA and RHEUMATOID ARTHRITIS.

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