Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00475332
Status:
TERMINATED
Last Update Posted:
2012-02-15
First Post:
2007-05-16
Brief Title:
Study to Treat Relapsed Follicular Non-Hodgkins Lymphoma With Radiation and Bexxar
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
Official Title:
Feasibility Study of External Beam Radiotherapy and Iodine-131 Tositumomab Bexxar for Patients With Relapsed Follicular Non-Hodgkins Lymphoma
Status:
TERMINATED
Status Verified Date:
2012-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI left our institution
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine the feasibility of treating relapsed follicular lymphoma with a combination of Bexxar and External Beam Radiotherapy EBRT Patients will receive EBRT 20 Gy in 10 fractions followed by Bexxar
Detailed Description:
Total dose delivered and tumor size are important predictors of local control in the treatment of low-grade Non-Hodgkins Lymphoma NHL The basic principle is that larger nodal masses require increased doses of External Beam Radiotherapy EBRT to achieve local control Radioimmunotherapy RIT seems to share this same characteristic Review of the published literature on both Bexxar and Zevalin reveals that one of the most important predictors of treatment failure is nodal volume and its apparent relationship to dose delivered by RIT The best tumor dosimetry for RIT is from Dr Wiseman et al reporting on the dosimetry of Zevalin PMID11418315 He showed that tumors 15 cm3 received only 1082 cGy with Zevalin whereas the average dose delivered in tumors 15 cm3 was 4763 cGy Recently Gokhale et al PMID16111589 published their experience with Zevalin at Cleveland Clinic and showed a significant correlation with pretreatment tumor volume and response to therapy In their experience tumors 5 cm had an 83 rate of local recurrence versus 28 for tumors 5 cm This dosing paradox bigger masses which require more dose receive less with RIT may be diminished by the delivery of additional EBRT This is the hypothesis that underlies the pilot study
The dosimetric data available for Bexxar is more heterogeneous but confirms the observations seen with Zevalin In patients previously untreated for low-grade Non-Hodgkins Lymphoma NHL Koral et al PMID12621015 showed an increased likelihood of achieving a complete response CR if tumor doses were 650 cGy Previous work by these same authors showed a trend for larger tumor volumes receiving less dose PMID10994741 The most compelling data for this relationship comes from the clinical trials done using Bexxar Both in the pivotal trial PMID11579112 and the recently published trial treating naïve patients PMID15689582 tumor volume was a significant predictor of response to Bexxar In the pivotal trial smaller tumor burden was the only factor predicting longer duration of response
Whereas EBRT might be able to provide reliable radiation dose the use of Bexxar may provide the therapeutic equivalent of central lymphatic irradiation which would permit the use of true involved field radiotherapy Investigators have previously noted that increased EBRT field size is associated with increased short-term and long-term toxicity The toxicities associated with the treatment of radiotherapy are related to the site treated but do not necessarily include the dose limiting toxicity of Bexxar which is primarily hematologic and transient As the toxicity of RT and Bexxar may not overlap the combination of both may allow an increase in the therapeutic window for both radiotherapy and Bexxar therapy
The dosimetric data available for Bexxar is more heterogeneous but confirms the observations seen with Zevalin In patients previously untreated for low-grade Non-Hodgkins Lymphoma NHL Koral et al PMID12621015 showed an increased likelihood of achieving a complete response CR if tumor doses were 650 cGy Previous work by these same authors showed a trend for larger tumor volumes receiving less dose PMID10994741 The most compelling data for this relationship comes from the clinical trials done using Bexxar Both in the pivotal trial PMID11579112 and the recently published trial treating naïve patients PMID15689582 tumor volume was a significant predictor of response to Bexxar In the pivotal trial smaller tumor burden was the only factor predicting longer duration of response
Whereas EBRT might be able to provide reliable radiation dose the use of Bexxar may provide the therapeutic equivalent of central lymphatic irradiation which would permit the use of true involved field radiotherapy Investigators have previously noted that increased EBRT field size is associated with increased short-term and long-term toxicity The toxicities associated with the treatment of radiotherapy are related to the site treated but do not necessarily include the dose limiting toxicity of Bexxar which is primarily hematologic and transient As the toxicity of RT and Bexxar may not overlap the combination of both may allow an increase in the therapeutic window for both radiotherapy and Bexxar therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None