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Iodine I 131 Tositumomab, Etoposide, and Cyclophosphamide Followed by Autologous Stem Cell Transplantation in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

2014-08-27 03:54:45 | BioPortfolio

Summary

RATIONALE: Radiolabeled monoclonal antibodies, such as iodine I 131 tositumomab, can locate cancer cells and deliver radioactive cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as etoposide and cyclophosphamide, use different ways to stop cancer cells from dividing so they stop growing or die. Combining a radiolabeled monoclonal antibody with combination chemotherapy before autologous stem cell transplantation may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combining iodine I 131 tositumomab with etoposide and cyclophosphamide followed by autologous stem cell transplantation in treating patients who have relapsed or refractory non-Hodgkin's lymphoma.

Description

OBJECTIVES:

Primary

- Determine the progression-free survival of patients with relapsed or refractory non-Hodgkin's lymphoma treated with iodine I 131 tositumomab, etoposide, and cyclophosphamide followed by autologous stem cell transplantation.

- Determine the safety of this regimen in these patients.

Secondary

- Determine the overall survival of patients treated with this regimen.

- Determine the toxicity and tolerability of this regimen in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to REAL classification histology (mantle cell lymphoma vs indolent lymphoma vs aggressive lymphoma).

- Radioimmunotherapy: Patients receive a test dose of iodine I 131 tositumomab on day -24 to determine biodistribution. Patients then receive therapeutic iodine I 131 tositumomab IV over approximately 40-60 minutes on day -14 and are entered into radiation isolation until day -4.

- Chemotherapy: Patients receive etoposide IV over 4 hours on day -4 and cyclophosphamide IV on day -2.

- Autologous stem cell transplantation: Patients undergo autologous bone marrow or peripheral blood stem cell transplantation on day 0. Patients undergoing bone marrow transplantation receive filgrastim (G-CSF) or sargramostim (GM-CSF) subcutaneously beginning on day 0 and continuing until blood counts recover.

Patients are followed at 1, 3, 6, and 12 months and then annually thereafter.

PROJECTED ACCRUAL: A total of 140 patients (40 with mantle cell lymphoma, 50 with indolent lymphoma, and 50 with aggressive lymphoma) will be accrued for this study within 4.6-9.2 years.

Study Design

Masking: Open Label, Primary Purpose: Treatment

Conditions

Lymphoma

Intervention

filgrastim, sargramostim, cyclophosphamide, etoposide, autologous bone marrow transplantation, peripheral blood stem cell transplantation, tositumomab and iodine I 131 tositumomab

Location

Seattle Cancer Care Alliance
Seattle
Washington
United States
98109-1023

Status

Recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:54:45-0400

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Medical and Biotech [MESH] Definitions

Transfer of HEMATOPOIETIC STEM CELLS from BONE MARROW or BLOOD between individuals within the same species (TRANSPLANTATION, HOMOLOGOUS) or transfer within the same individual (TRANSPLANTATION, AUTOLOGOUS). Hematopoietic stem cell transplantation has been used as an alternative to BONE MARROW TRANSPLANTATION in the treatment of a variety of neoplasms.

Techniques for the removal of subpopulations of cells (usually residual tumor cells) from the bone marrow ex vivo before it is infused. The purging is achieved by a variety of agents including pharmacologic agents, biophysical agents (laser photoirradiation or radioisotopes) and immunologic agents. Bone marrow purging is used in both autologous and allogeneic BONE MARROW TRANSPLANTATION.

A cell-separation technique where magnetizable microspheres or beads are first coated with monoclonal antibody, allowed to search and bind to target cells, and are then selectively removed when passed through a magnetic field. Among other applications, the technique is commonly used to remove tumor cells from the marrow (BONE MARROW PURGING) of patients who are to undergo autologous bone marrow transplantation.

Agents that destroy bone marrow activity. They are used to prepare patients for BONE MARROW TRANSPLANTATION or STEM CELL TRANSPLANTATION.

The transference of BONE MARROW from one human or animal to another for a variety of purposes including HEMATOPOIETIC STEM CELL TRANSPLANTATION or MESENCHYMAL STEM CELL TRANSPLANTATION.

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