NCT00777114

Phase 1 Study of Radiosensitization Using Bortezomib in Relapsed Non-Hodgkin's Lymphoma Patients Receiving Radioimmunotherapy

Completed Phase 1 Last updated 13 August 2018

What this trial tests

Phase 1 trial testing bortezomib, tositumomab in Non-Hodgkin's Lymphoma in 31 participants. Completed in 18 December 2012.

Timeline

1 April 2007

Primary endpoint
18 December 2012

18 December 2012

Quick facts

Lead sponsor	Weill Medical College of Cornell University
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	31
Start date	1 April 2007
Primary completion	18 December 2012
Estimated completion	18 December 2012
Sites	2 locations across United States

Drugs / interventions tested

• bortezomib, tositumomab — full drug profile →

Conditions studied

• Non-Hodgkin's Lymphoma — all drugs for Non-Hodgkin's Lymphoma →

Sponsor

Weill Medical College of Cornell University

Who can join

18 and older, any sex, with Non-Hodgkin's Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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:

1. 0.30mg/m2 bortezomib and 50cGy 131I-tositumomab,
2. 0.30 mg/m2 bortezomib and 75 cGy 131I-tositumomab,
3. 0.60 mg/m2 bortezomib and 75 cGy 131I-tositumomab,
4. 0.90 mg/m2 bortezomib and 75 cGy 131I-tositumomab, and
5. 1.2 mg/m2 bortezomib and 75 cGy 131I-tositumomab.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Phase 1 study of radiosensitization using bortezomib in patients with relapsed non-Hodgkin lymphoma receiving radioimmunotherapy with 131I-tositumomab.
   Elstrom RL, Ruan J, Christos PJ, Martin P, et al · · 2015 · cited 10× · PMID 24730538 · DOI 10.3109/10428194.2014.914195