- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00490490
Study of Bexxar <Tositumomab> Combined With External Beam Radiation Therapy
February 9, 2017 updated by: Susan Knox, Stanford University
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).
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
8
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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Stanford, California, United States, 94305
- Stanford University School of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
17 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
INCLUSION CRITERIA
- 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
- 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
EXCLUSION CRITERIA
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tositumomab + XRT + KI
Tositumomab + external beam radiotherapy (XRT) + potassium iodide (KI)
|
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.
Other Names:
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.
Other Names:
Potassium iodide (KI) will be administered as:
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complete Response (CR) Rate
Time Frame: 12 weeks
|
Participants assessed for by the following Complete Response (CR) criteria CR or Functional CR
CR Unconfirmed (CRu) criteria
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Response Rate (ORR)
Time Frame: 12 weeks
|
ORR is assessed as the sum of the overall rates of
|
12 weeks
|
Time-to-Progression (TTP)
Time Frame: 2 years
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2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Susan J Knox, Stanford University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2007
Primary Completion (Actual)
June 1, 2011
Study Completion (Actual)
July 1, 2013
Study Registration Dates
First Submitted
June 20, 2007
First Submitted That Met QC Criteria
June 20, 2007
First Posted (Estimate)
June 22, 2007
Study Record Updates
Last Update Posted (Actual)
March 29, 2017
Last Update Submitted That Met QC Criteria
February 9, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma
- Lymphoma, Non-Hodgkin
- Physiological Effects of Drugs
- Anti-Infective Agents, Local
- Anti-Infective Agents
- Trace Elements
- Micronutrients
- Hemostatics
- Coagulants
- Iodine
- Pharmaceutical Solutions
- Lugol's solution
Other Study ID Numbers
- IRB-07479
- 97437 (Other Identifier: Stanford University Alternate IRB Approval Number)
- LYMNHL0046 (Other Identifier: OnCore)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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