Phase 1 Study of Radiosensitization Using Bortezomib in Relapsed Non-Hodgkin's Lymphoma Patients Receiving Radioimmunotherapy
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|ClinicalTrials.gov Identifier: NCT00777114|
Recruitment Status : Completed
First Posted : October 22, 2008
Last Update Posted : August 13, 2018
This will be a multi-center, Phase I, dose-escalation study of bortezomib in combination with 131I-tositumomab in patients with relapsed non-Hodgkin's lymphoma. Bortezomib will be administered to patients twice weekly, with the first dose being given two days prior to the treatment dose of 131I-tositumomab, and the second dose two days after RIT for a total of 5 doses.
Patients will be enrolled and undergo standard staging studies, including history, physical examination, complete blood count, serum chemistries and LDH, TSH, HAMA, iliac crest bone marrow biopsy, and CT scans of the chest, abdomen and pelvis. All patients will provide written informed consent.
Bortezomib will be evaluated at 4 dose levels (0.30 mg/m2, 0.60 mg/m2, 0.90 mg/m2, and 1.2 mg/m2) and 131I-tositumomab at 2 dose levels (50 cGy and 75 cGy TBD). Bortezomib will be administrated the day prior to 131I-tositumomab and twice weekly thereafter for 4 doses in order to provide proteasome inhibition throughout the period of 131I-tositumomab activity. The intention is to use 131I-tositumomab at full dose if possible. Therefore, the 50cGy dose will be used only with the lowest dose of bortezomib in case of unexpected toxicities with the combination.
Dose levels will be as follow:
- 0.30mg/m2 bortezomib and 50cGy 131I-tositumomab,
- 0.30 mg/m2 bortezomib and 75 cGy 131I-tositumomab,
- 0.60 mg/m2 bortezomib and 75 cGy 131I-tositumomab,
- 0.90 mg/m2 bortezomib and 75 cGy 131I-tositumomab, and
- 1.2 mg/m2 bortezomib and 75 cGy 131I-tositumomab.
|Condition or disease||Intervention/treatment||Phase|
|Non-Hodgkin's Lymphoma||Drug: bortezomib, tositumomab||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1 Study of Radiosensitization Using Bortezomib in Relapsed Non-Hodgkin's Lymphoma Patients Receiving Radioimmunotherapy|
|Actual Study Start Date :||April 1, 2007|
|Actual Primary Completion Date :||December 18, 2012|
|Actual Study Completion Date :||December 18, 2012|
|Experimental: All patients||
Drug: bortezomib, tositumomab
- The primary objectives of this study are to determine: a) The appropriate doses of bortezomib and 131I-tositumomab when used in combination. b) Toxicities of the combination treatment. [ Time Frame: throughout dose escalation treatments ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00777114
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States|
|United States, New York|
|Weill Cornell Medical College|
|New York, New York, United States, 10021|
|Principal Investigator:||Jia Ruan, MD, PhD||Weill Medical College of Cornell University|