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NCT00777114 · ClinicalTrials.gov registry record · Phase 1
Phase 1 Study of Radiosensitization Using Bortezomib in Relapsed Non-Hodgkin's Lymphoma Patients Receiving Radioimmunotherapy
A Phase 1 study, sponsored by Weill Medical College of Cornell University.
- Completed
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
NCT00777114: Completed Phase 1 study, sponsored by Weill Medical College of Cornell University.
NCT00777114 is a Phase 1 study that has completed, run by Weill Medical College of Cornell University. The registered enrollment target is 31 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00777114, a Phase 1 study, has completed, sponsored by Weill Medical College of Cornell University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG bortezomib, tositumomab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2007-04-01 |
| Est. Completion | 2012-12-18 |
| Phase | Phase 1 |
What the finished NCT00777114 record still lists
NCT00777114 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 1 intervention - of which bortezomib, tositumomab is the first listed.
NCT00777114 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00777114 about?
NCT00777114 is a clinical study titled "Phase 1 Study of Radiosensitization Using Bortezomib in Relapsed Non-Hodgkin's Lymphoma Patients Receiving Radioimmunotherapy". 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-tosi...
What is the current status of trial NCT00777114?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2007-04-01. Estimated completion is 2012-12-18.
What interventions are being tested in trial NCT00777114?
The interventions under investigation include: bortezomib, tositumomab (DRUG).
Who is sponsoring clinical trial NCT00777114?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00777114's enrollment target sits among peer trials
31 1322nd of 2000 higher than 669 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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