Iodine I 131 Tositumomab and Fludarabine Phosphate in Treating Older Patients Who Are Undergoing an Autologous or Syngeneic Stem Cell Transplant for Relapsed or Refractory Non-Hodgkin's Lymphoma



Status:Archived
Conditions:Lymphoma, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:Any
Updated:7/1/2011

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A Clinical Trial Evaluating I131-Tositumomab (Anti-CD20) With Escalating Doses of Fludarabine Followed by Autologous or Syngeneic Stem Cell Transplantation for Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma in Patients 60 Years of Age and Older


RATIONALE: Radiolabeled monoclonal antibodies, such as iodine I 131 tositumomab, can find
cancer cells and carry cancer-killing substances to them without harming normal cells. Drugs
used in chemotherapy, such as fludarabine phosphate, work in different ways to stop the
growth of cancer cells, either by killing the cells or by stopping them from dividing. A
peripheral stem cell transplant may be able to replace blood-forming cells that were
destroyed by chemotherapy and radiation therapy. Giving iodine I 131 tositumomab together
with fludarabine phosphate followed by autologous stem cell transplant may be an effective
treatment for non-Hodgkin's lymphoma.

PURPOSE: This phase I trial is studying the side effects and best dose of fludarabine when
given together with iodine I 131 tositumomab in treating older patients who are undergoing
an autologous or syngeneic stem cell transplant for relapsed or refractory B-cell
non-Hodgkin's lymphoma.


PRIMARY OBJECTIVES:

I. To estimate the maximally tolerated dose of fludarabine that can be combined with
131I-anti-CD20 delivering =< 27Gy to critical normal organs followed by autologous or
syngeneic transplantation in patients >= 60 years of age with relapsed B-NHL.

SECONDARY OBJECTIVES:

I. To assess the overall and progression-free survival of the above regimen in such
patients.

II. To evaluate the response rates of the above therapy. III. To evaluate the toxicity and
tolerability of the above therapy. IV. To evaluate the feasibility of delivering concurrent
high-dose RIT and chemotherapy.

OUTLINE: This is a dose-escalation study of fludarabine phosphate.

Patients receive a dosimetric dose of iodine I 131 tositumomab IV over 40-60 minutes on day
-24 followed by dosimetry periodically over the next 6 days. Patients then receive a
therapeutic dose of iodine I 131 tositumomab IV over 40-60 minutes on day -14. Patients also
receive fludarabine phosphate IV once daily on days -11 to -9 OR days -11 or -7. Patients
undergo autologous or syngeneic peripheral blood stem cell transplantation on day 0.

Patients with circulating lymphoma cells by peripheral smear receive tositumomab IV over 1
hour OR rituximab IV over 1 hour followed by tositumomab IV over 1 hour before the
dosimetric iodine I 131 tositumomab infusion.

After completion of study treatment, patients are followed at 1, 3, 6, and 12 months and
then annually thereafter.


We found this trial at
1
site
1100 Fairview Avenue North
Seattle, Washington 98109
(206) 667-5000
Fred Hutchinson Cancer Research Center At Fred Hutchinson Cancer Research Center, our interdisciplinary teams of...
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from
Seattle, WA
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