Study of Dynavax's 1018 ISS, Following Rituxan in Patients With B-Cell Follicular Lymphoma
NCT ID: NCT00251394
Last Updated: 2010-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
30 participants
INTERVENTIONAL
2004-07-31
2009-07-31
Brief Summary
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Detailed Description
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* After completion of the 5-week treatment period, a physical examination and blood work will be performed. The patient will also be examined to see if the tumor has gotten smaller, bigger, or stayed the same size and in the same places by either CT scan or MRI. A bone marrow aspiration and biopsy will be done to examine any changes in bone marrow cells.
* The following tests will be performed to determine whether or not a patient is eligible to participate in this clinical study: Bone marrow aspiration and biopsy; lymph node biopsy; skin biopsy; standard x-ray tests (x-rays, CT scans, MRI, ultrasounds, and/or radioactive drug scans); and blood work.
* While receiving treatment patients will have the following procedures done; Physical examination once a week for 4 weeks, blood testing for any changes in the blood, blood chemistry and other blood components. Patients will also be requested to keep a diary between each study visit to record any health changes or any over-the-counter medication or herbal preparation they may have taken.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Rituxan
Given intravenously once weekly for four weeks.
1018 ISS
Given as an injection under the skin after the 2nd, 3rd and 4th rituxan infusion. One week after the last rituxan infusion is given, a fourth and final 1018ISS injection will be given.
Eligibility Criteria
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Inclusion Criteria
* Pathological evidence of CD20+, B-cell follicular non-Hodgkin's lymphoma
* Received at least one previous chemotherapy regimen for lymphoma
* Hemoglobin \> 8.5 g/dl
* WBC \> 2,000/mm3
* ANC \> 1,000/mm3
* Platelet count \> 75,000/mm3
* ECOG performance status of less than or equal to 2
* Life expectancy of greater than 4 months
* Women and men of childbearing potential must be willing to use highly effective methods of birth control for duration of time on the study
Exclusion Criteria
* Treatment with chemotherapy, including systemic steroids, or radiation therapy within 30 days
* Current use of systemic or inhaled steroids
* Treatment with radioimmunotherapy, autologous stem cell transplantation, or fludarabine within 6 months
* Disease progression within 6 months of any previous rituximab therapy
* History of allogenic transplantation, including nonmyeloablative transplantation
* Unstable angina, symptomatic cardiac arrhythmia or clinical heart failure
* Severe pulmonary disease, symptomatic pleural effusions, or clinically significant pulmonary symptoms
* Active infection requiring systemic antibiotic, antiviral, or antifungal therapy
* Clinically apparent CNS lymphoma
* Major surgery within 2 weeks
* Known human anti-murine antibody (HAMA) or human anti-chimeric antibody (HACA) response
* Known Hepatitis B surface antigen positive
* History of autoimmune disorder
* Current therapeutic use of anticoagulants
* History of coagulopathy
* Known allergy to any of the components of 1018 ISS or Rituxan
* Participation in another investigational trial within 30 days
* Any clinically significant abnormality in screening blood chemistry, hematology, or urinalysis
18 Years
ALL
No
Sponsors
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Dynavax Technologies Corporation
INDUSTRY
James P. Wilmot Cancer Center
OTHER
University of Rochester
OTHER
Brigham and Women's Hospital
OTHER
Massachusetts General Hospital
OTHER
Dana-Farber Cancer Institute
OTHER
Responsible Party
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Dana-Farber Cancer Institute
Principal Investigators
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Arnold Freedman, MD
Role: PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Countries
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Other Identifiers
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R21
Identifier Type: -
Identifier Source: secondary_id
U10402
Identifier Type: -
Identifier Source: secondary_id
03-411
Identifier Type: -
Identifier Source: org_study_id