Non-Hodgkin's LymphomaPhase 1NCT00777114
Phase 1 Study of Radiosensitization Using Bortezomib in Relapsed Non-Hodgkin's Lymphoma Patients Receiving Radioimmunotherapy
A Phase 1 study testing bortezomib, tositumomab in people with Non-Hodgkin's Lymphoma, run by Weill Medical College of Cornell University at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Hodgkin's Lymphoma
- What is being tested?
- bortezomib, tositumomab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Apr 2007to 18 Dec 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have histologically proven relapsed or refractory MCL, DLBCL including subtypes mediastinal large B cell, centroblastic, immunoblastic, T cell rich B cell and anaplastic large B cell lymphoma, or low grade B cell NHL.
- Patients must have received prior systemic therapy for their lymphoma.
- Age >18 years.
- Life expectancy of greater than 12 weeks
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Patients may not be receiving any other investigational agents.
- Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to bortezomib or boron.
- Previous radiation therapy to the maximum tissue tolerance at any site.
- Previous autologous or allogeneic stem cell transplantation.
- Involvement of the bone marrow of >25% by lymphoma.
Show all 16Show fewer
- Known involvement of the central nervous system by lymphoma. 17
- Significant organ dysfunction, including hematologic (absolute neutrophil count <1500, platelets <150,000).
- ECOG performance status >2.
- Uncontrolled illness including, but not limited to, ongoing or active infection,symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- HIV infection.
- Patient has a calculated or measured creatinine clearance of <20 mL/minute within 14 days before enrollment.
- Patient has ≥Grade 2 peripheral neuropathy within 14 days before enrollment.
- Myocardial infarction within 3 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure (see section 8.4), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at screening has to be documented by the investigator as not medically relevant.
- Patient has hypersensitivity to bortezomib, boron or mannitol.
- Female subject is pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Michigan
Ann Arbor, Michigan
Weill Cornell Medical College
New York, New York, 10021
About this study
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.
Read more
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.
- Conditions
- Non-Hodgkin's Lymphoma
- Being tested
- bortezomib, tositumomab
- Keywords
- relapsed non-Hodgkin's lymphoma
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bortezomib, tositumomabDrug
- 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.
| Study group | Role | What they receive |
|---|---|---|
| All patients | Experimental | Not described Receives: Drug: bortezomib, tositumomab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: throughout dose escalation treatments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2008 (estimated)
- Study start1 Apr 2007
- Primary completion18 Dec 2012
- Study completion18 Dec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Hodgkin's LymphomaStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Millennium Pharmaceuticals, Inc., GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Jia Ruan, MD, PhD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00777114
- Sponsor's protocol ID
- 0806009862
- Status last verified
- Aug 2018
- First submitted
- 21 Oct 2008
- Last updated
- 13 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Radiosensitization Using Bortezomib in Relapsed Non-Hodgkin's Lymphoma Patients Receiving Radioimmunotherapy
- ClinicalTrials.gov ID
- NCT00777114
- Acronym / sponsor ID
- 0806009862
- Conditions
- Non-Hodgkin's Lymphoma
- Keywords
- relapsed non-Hodgkin's lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Millennium Pharmaceuticals, Inc., GlaxoSmithKline
- Study start
- 1 Apr 2007 (actual)
- Primary completion
- 18 Dec 2012 (actual)
- Study completion
- 18 Dec 2012 (actual)
- First posted
- 22 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | Experimental | Drug: bortezomib, tositumomab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients must have histologically proven relapsed or refractory MCL, DLBCL including subtypes mediastinal large B cell, centroblastic, immunoblastic, T cell rich B cell and anaplastic large B cell lymphoma, or low grade B cell NHL.
- Patients must have received prior systemic therapy for their lymphoma.
- Age >18 years.
- Life expectancy of greater than 12 weeks
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Key exclusion criteria (16 listed)
- Patients may not be receiving any other investigational agents.
- Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to bortezomib or boron.
- Previous radiation therapy to the maximum tissue tolerance at any site.
- Previous autologous or allogeneic stem cell transplantation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bortezomib, tositumomab1. 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. | Drug | All patients |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jia Ruan, MD, PhD principal investigator
Weill Medical College of Cornell University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing bortezomib, tositumomab in people with Non-Hodgkin's Lymphoma, run by Weill Medical College of Cornell University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2018.