Lymphoma, Non-HodgkinPhase 2NCT00490490
Study of Bexxar <Tositumomab> Combined With External Beam Radiation Therapy
A Phase 2 study testing Bexxar (tositumomab), External beam radiotherapy (XRT) and Potassium Iodide (KI) in people with Lymphoma, Non-Hodgkin, run by Stanford University at 1 site in United States.
Trial summary
The purpose of the study is to assess the response rate of patients with relapsed or refractory low-grade or transformed low-grade, CD20-positive, B-cell non-Hodgkin's lymphoma to Iodine-131 (I-131) tositumomab (Bexxar) therapy plus local palliative radiation therapy (XRT). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Lymphoma, Non-Hodgkin
- What is being tested?
- Bexxar (tositumomab), External beam radiotherapy (XRT) and Potassium Iodide (KI)
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Jul 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed low grade CD20+ B cell non-Hodgkin lymphoma (NHL) patients who have relapsed after chemotherapy or are chemotherapy resistant and have one or more sites of disease measuring more than 5 cm.
- The patients must have failed at least one chemotherapy regimen
- No anticancer treatment for three weeks prior to study initiation (six weeks if Rituximab, nitrosourea or Mitomycin C)
- Fully recovered from all toxicities associated with prior surgery, radiation, chemotherapy or immunotherapy
- An institutional review board- (IRB)-approved signed informed consent
- Age 19 years or older
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- Expected survival of at least 6 months
- Prestudy Performance Status of 0, 1 or 2 according to the World Health Organization (WHO)
- Absolute neutrophil count (ANC) of at least 1,500/mm³
- Platelet count at least 100,000/mm³
- Hct > 30%
- Hgb > 9.0 gm
- Bilirubin ≤ 2.0
- Creatinine ≤ 2.0
- Bone marrow involvement with lymphoma less than 25% (bilateral bone marrow) within 6 weeks of enrollment
- Acceptable birth control method for men and women
Who cannot join
- Disease progression within 3 months of last chemotherapy
- Prior myeloablative therapies with bone marrow transplantation or peripheral stem cell rescue
- Platelet count less than 100,000/mm³
- Hypocellular bone marrow (≤ 15% cellularity)
- Marked reduction in bone marrow precursors of one or more cell lines
- History of failed stem cell collection
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- Prior treatment with fludarabine
- Prior radioimmunotherapy
- Presence of central nervous system (CNS) lymphoma
- HIV or AIDS-related lymphoma
- Evidence of myelodysplasia on bone marrow biopsy
- Abnormal bone marrow cytogenetics
- Patients who have received prior external beam radiation therapy to more than 25% of active bone marrow
- Patients who have received filgrastim
- Sargramostim therapy within 3 weeks prior to treatment
- Presence of human anti-mouse antibody (HAMA) reactivity in patients with prior exposure to murine antibodies or proteins
- Serious nonmalignant disease or infection, which, in the opinion of the investigator and/or sponsor, would compromise other protocol objectives
- Another primary malignancy (other than squamous cell and basal cell cancer of the skin, in situ carcinoma of the cervix, or treated prostate cancer with stable prostate-specific antigen, PSA) for which the patients has not been disease free for at least 3 years
- Major surgery, other than diagnostic surgery within 4 weeks
- Pleural effusion
- Pregnant
- Lactating
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: Study of Bexxar <Tositumomab> Combined With External Beam Radiation Therapy for Patients With Relapsed, Bulky Non-Hodgkin's Lymphoma
The purpose of the study is to assess the response rate of patients with relapsed or refractory low-grade or transformed low-grade, CD20-positive, B-cell non-Hodgkin's lymphoma to Iodine-131 (I-131) tositumomab (Bexxar) therapy plus local palliative radiation therapy (XRT).
Read the detailed description
Response will be assessed on the basis of the presence or absence of measurable lesion ≥ 1.4 x 1.4 cm (operationally defined as ≥ 2.0 cm2) by radiographic evaluation OR ≥ 1.0 cm in greatest diameter detected by palpation on physical exam
- Conditions
- Lymphoma, Non-Hodgkin
- Being tested
- Bexxar (tositumomab), External beam radiotherapy (XRT), Potassium Iodide (KI)
- 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.
Bexxar (tositumomab)Drug
Also called 131-iodine tositumomab
Tositumomab is a CD20-directed radiotherapeutic (131-iodine) monoclonal antibody indicated for the treatment of patients with CD20-positive, relapsed or refractory, low-grade, follicular, or transformed non-Hodgkin's lymphoma who have progressed during or after rituximab therapy, including patients with rituximab-refractory non-Hodgkin's lymphoma. Tositumomab (standard regimen) will be administered at whole body exposure of 75 cGy.
External beam radiotherapy (XRT)Procedure or surgery
Also called Radiotherapy (RT)
Patient-specific XRT will begin within 24 hours of administration of the therapeutic dose of tositumomab. Subjects will receive local XRT to bulky sites of disease measuring at least 5 cm in at least one dimension. The size and number of fields to be treated will determined by the investigators, but will encompass the patient's most symptomatic/threatening site(s) of disease and not cumulatively include more than 25% of the active bone marrow. Subjects will be treated with the 2 x 2 Gy regimen (2 daily fractions of 2 Gy). Sites of disease previously-irradiated with 30 to 40 Gy will not be treated on this study.
Potassium Iodide (KI)Drug
Also called Saturated Solution Potassium Iodide (SSKI), Lugol's solution, Potassium iodide tablets
Potassium iodide (KI) will be administered as:
- Saturated solution potassium iodide (SSKI) 4 drops orally 3-times-a-day,
- Lugol's solution 20 drops orally 3-times-a-day, OR
- KI tablets 130 mg orally once per day KI treatment will start at least 24 hours prior to tositumomab, and continue daily for 14 days following the last dose of tositumomab
| Study group | Role | What they receive |
|---|---|---|
| Tositumomab + XRT + KI | Experimental | Tositumomab + external beam radiotherapy (XRT) + potassium iodide (KI) Receives: Drug: Bexxar (tositumomab); Procedure: External beam radiotherapy (XRT); Drug: Potassium Iodide (KI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response (CR) Rate
Participants assessed for by the following Complete Response (CR) criteria
CR or Functional CR
- No evidence of disease and symptoms
- Any macroscopic nodules detected in any organs no longer present.
- Any palpable lymph node is normal and greatest diameter is < 1.0 cm.
- The enlarged organs decreased in size and not palpable
- The bone marrow biopsy and aspirate are negative for disease
- Negative for disease by PET-scan (functional CR)
CR Unconfirmed (CRu) criteria
- No evidence of disease and symptoms
- Any lymph node mass > 1.0 cm^2 diameter has regressed is size by more than 75%.
- No macroscopic nodules in any organs
- Any palpable lymph node is normal and greatest diameter is < 1.0 cm.
- The bone marrow biopsy and aspirate are negative for disease
- The bone marrow biopsy may have increased number or size of lymphoid aggregates without cytologic or architectural atypia
Measured: 12 weeks
Secondary outcomes (2)
Overall Response Rate (ORR)
ORR is assessed as the sum of the overall rates of
- CR confirmed by positron emission tomography (PET)
- CR not confirmed by PET, and
- Partial response (PR) negative for progression by PET
Measured: 12 weeks
Time-to-Progression (TTP)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2007 (estimated)
- Study startJan 2007
- Primary completionJun 2011
- Study completionJul 2013
Why it stopped: Low Accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lymphoma, Non-HodgkinStudies of the same condition, open and under way.
- More trials run by Stanford 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Principal investigator, Susan Knox, Stanford University
- Investigators
- Susan J Knox, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00490490
- Sponsor's protocol ID
- IRB-07479
- Other IDs
- 97437, LYMNHL0046
- Status last verified
- Feb 2017
- First submitted
- 20 Jun 2007
- Last updated
- 29 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Bexxar <Tositumomab> Combined With External Beam Radiation Therapy for Patients With Relapsed, Bulky Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT00490490
- Acronym / sponsor ID
- IRB-07479
- Conditions
- Lymphoma, Non-Hodgkin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low Accrual
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Jan 2007
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 22 Jun 2007 (estimated)
- Results
- Posted 29 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to assess the response rate of patients with relapsed or refractory low-grade or transformed low-grade, CD20-positive, B-cell non-Hodgkin's lymphoma to Iodine-131 (I-131) tositumomab (Bexxar) therapy plus local palliative radiation therapy (XRT).
Detailed description
Response will be assessed on the basis of the presence or absence of measurable lesion ≥ 1.4 x 1.4 cm (operationally defined as ≥ 2.0 cm2) by radiographic evaluation OR ≥ 1.0 cm in greatest diameter detected by palpation on physical exam
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tositumomab + XRT + KI | Experimental | Drug: Bexxar (tositumomab), Procedure: External beam radiotherapy (XRT), Drug: Potassium Iodide (KI)Tositumomab + external beam radiotherapy (XRT) + potassium iodide (KI) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Histologically confirmed low grade CD20+ B cell non-Hodgkin lymphoma (NHL) patients who have relapsed after chemotherapy or are chemotherapy resistant and have one or more sites of disease measuring more than 5 cm.
- The patients must have failed at least one chemotherapy regimen
- No anticancer treatment for three weeks prior to study initiation (six weeks if Rituximab, nitrosourea or Mitomycin C)
- Fully recovered from all toxicities associated with prior surgery, radiation, chemotherapy or immunotherapy
- An institutional review board- (IRB)-approved signed informed consent
Key exclusion criteria (22 listed)
- Disease progression within 3 months of last chemotherapy
- Prior myeloablative therapies with bone marrow transplantation or peripheral stem cell rescue
- Platelet count less than 100,000/mm³
- Hypocellular bone marrow (≤ 15% cellularity)
- Marked reduction in bone marrow precursors of one or more cell lines
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 |
|---|---|---|
| Bexxar (tositumomab)Also: 131-iodine tositumomabTositumomab is a CD20-directed radiotherapeutic (131-iodine) monoclonal antibody indicated for the treatment of patients with CD20-positive, relapsed or refractory, low-grade, follicular, or transformed non-Hodgkin's lymphoma who have progressed during or after rituximab therapy, including patients with rituximab-refractory non-Hodgkin's lymphoma. Tositumomab (standard regimen) will be administered at whole body exposure of 75 cGy. | Drug | Tositumomab + XRT + KI |
| External beam radiotherapy (XRT)Also: Radiotherapy (RT)Patient-specific XRT will begin within 24 hours of administration of the therapeutic dose of tositumomab. Subjects will receive local XRT to bulky sites of disease measuring at least 5 cm in at least one dimension. The size and number of fields to be treated will determined by the investigators, but will encompass the patient's most symptomatic/threatening site(s) of disease and not cumulatively include more than 25% of the active bone marrow. Subjects will be treated with the 2 x 2 Gy regimen (2 daily fractions of 2 Gy). Sites of disease previously-irradiated with 30 to 40 Gy will not be treated on this study. | Procedure or surgery | Tositumomab + XRT + KI |
| Potassium Iodide (KI)Also: Saturated Solution Potassium Iodide (SSKI), Lugol's solution, Potassium iodide tabletsPotassium iodide (KI) will be administered as: * Saturated solution potassium iodide (SSKI) 4 drops orally 3-times-a-day, * Lugol's solution 20 drops orally 3-times-a-day, OR * KI tablets 130 mg orally once per day KI treatment will start at least 24 hours prior to tositumomab, and continue daily for 14 days following the last dose of tositumomab | Drug | Tositumomab + XRT + KI |
Primary outcome
Complete Response (CR) Rate
Time frame: 12 weeks
Participants assessed for by the following Complete Response (CR) criteria CR or Functional CR * No evidence of disease and symptoms * Any macroscopic nodules detected in any organs no longer present. * Any palpable lymph node is normal and greatest diameter is < 1.0 cm. * The enlarged organs decreased in size and not palpable * The bone marrow biopsy and aspirate are negative for disease * Negative for disease by PET-scan (functional CR) CR Unconfirmed (CRu) criteria * No evidence of disease and symptoms * Any lymph node mass > 1.0 cm^2 diameter has regressed is size by more than 75%. * No macroscopic nodules in any organs * Any palpable lymph node is normal and greatest diameter is < 1.0 cm. * The bone marrow biopsy and aspirate are negative for disease * The bone marrow biopsy may have increased number or size of lymphoid aggregates without cytologic or architectural atypia
2 secondary outcomes
Overall Response Rate (ORR)
Time frame: 12 weeks
Time-to-Progression (TTP)
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Susan J Knox principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bexxar (tositumomab), External beam radiotherapy (XRT) and Potassium Iodide (KI) in people with Lymphoma, Non-Hodgkin, run by Stanford University at 1 site 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 16 inclusion and 22 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: stopped early, as of the sponsor's last update on 29 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Complete Response (CR) Rate (time frame: 12 weeks). 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 29 Mar 2017.