Non-Hodgkin's LymphomaPhase 2NCT00251394
Study of Dynavax's 1018 ISS, Following Rituxan in Patients With B-Cell Follicular Lymphoma
A Phase 2 study testing Rituxan and 1018 ISS in people with Non-Hodgkin's Lymphoma, run by Dana-Farber Cancer Institute at 3 sites in United States.
Trial summary
The main purpose of this study is to determine the effects (good and bad) and the safety of Dynavax's immunostimulatory phosphorothiolate oligodeoxyribonucleotide (1018 ISS) given in combination with Rituxan on patients with B-cell follicular non-Hodgkin's lymphoma. 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?
- Rituxan and 1018 ISS
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2004to Jul 2009
- Phase
- Phase 2
- 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
- 18 years of age or older
- 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
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- 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
Who cannot join
- Pregnant of lactating women
- 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
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- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: A Phase 2, Open-Label Study of the Efficacy, Safety, and Tolerability of Dynavax's Immunostimulatory Phosphorothiolate Oligodeoxyribonucleotide, 1018 ISS, Following Rituxan (Rituximab) Treatment in Patients With CD20+, B-Cell Follicular Non-Hodgkin's Lymphoma.
The main purpose of this study is to determine the effects (good and bad) and the safety of Dynavax's immunostimulatory phosphorothiolate oligodeoxyribonucleotide (1018 ISS) given in combination with Rituxan on patients with B-cell follicular non-Hodgkin's lymphoma. This research is being done because recurrent follicular non-Hodgkin's lymphoma is not curable with standard chemotherapy or antibody treatments. 1018 ISS is an experimental compound that consists of short pieces of DNA that stimulate the immune system. It is hoped that 1018 ISS may improve the ability of Rituxan to kill cancer cells.
Read the detailed description
- Patients will receive four weekly infusions of Rituxan which is standard treatment for B-cell non-Hodgkin's lymphoma. Approximately 30 to 60 minutes after the second, third and fourth infusions of Rituxan, the patient will receive up to 3 injections of 1018 ISS under the skin. The number of injections will depend upon the patients weight. One week after the last Rituxan infusion the patient will receive a fourth and final injection of 1018 ISS.
- 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
- Non-Hodgkin's Lymphoma
- Being tested
- Rituxan, 1018 ISS
- Keywords
- B-Cell follicular non-Hodgkin's lymphoma, Rituxan, Rituximab, 1018 ISS, CD 20 +
- 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.
RituxanDrug
Given intravenously once weekly for four weeks.
1018 ISSDrug
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the proportion of patients who are alive and without disease progression 1 year after initiating Rituxan plus 1018 ISS therapy.
Measured: 2 years
Secondary outcomes (4)
To assess the overall response rate following treatment
Measured: 2 years
to determine duration of response and time to progression
to further define the safety profile of 1018 ISS
Measured: 2 years
to explore the biologic activity of 1018 ISS.
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 posted10 Nov 2005 (estimated)
- Study startJul 2004
- Primary completionDec 2006
- Study completionJul 2009
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 Dana-Farber Cancer InstituteThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Dynavax Technologies Corporation, James P. Wilmot Cancer Center, University of Rochester, Brigham and Women's Hospital, Massachusetts General Hospital
- Investigators
- Arnold Freedman, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00251394
- Sponsor's protocol ID
- 03-411
- Other IDs
- R21, U10402
- Status last verified
- Jul 2009
- First submitted
- 8 Nov 2005
- Last updated
- 29 Jan 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open-Label Study of the Efficacy, Safety, and Tolerability of Dynavax's Immunostimulatory Phosphorothiolate Oligodeoxyribonucleotide, 1018 ISS, Following Rituxan (Rituximab) Treatment in Patients With CD20+, B-Cell Follicular Non-Hodgkin's Lymphoma.
- ClinicalTrials.gov ID
- NCT00251394
- Acronym / sponsor ID
- 03-411
- Conditions
- Non-Hodgkin's Lymphoma
- Keywords
- B-Cell follicular non-Hodgkin's lymphoma, Rituxan, Rituximab, 1018 ISS, CD 20 +
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Dynavax Technologies Corporation, James P. Wilmot Cancer Center, University of Rochester, Brigham and Women's Hospital, Massachusetts General Hospital
- Study start
- Jul 2004
- Primary completion
- Dec 2006 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 10 Nov 2005 (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.
The main purpose of this study is to determine the effects (good and bad) and the safety of Dynavax's immunostimulatory phosphorothiolate oligodeoxyribonucleotide (1018 ISS) given in combination with Rituxan on patients with B-cell follicular non-Hodgkin's lymphoma. This research is being done because recurrent follicular non-Hodgkin's lymphoma is not curable with standard chemotherapy or antibody treatments. 1018 ISS is an experimental compound that consists of short pieces of DNA that stimulate the immune system. It is hoped that 1018 ISS may improve the ability of Rituxan to kill cancer cells.
Detailed description
- Patients will receive four weekly infusions of Rituxan which is standard treatment for B-cell non-Hodgkin's lymphoma. Approximately 30 to 60 minutes after the second, third and fourth infusions of Rituxan, the patient will receive up to 3 injections of 1018 ISS under the skin. The number of injections will depend upon the patients weight. One week after the last Rituxan infusion the patient will receive a fourth and final injection of 1018 ISS.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 18 years of age or older
- 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
Key exclusion criteria (19 listed)
- Pregnant of lactating women
- 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
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 |
|---|---|---|
| RituxanGiven intravenously once weekly for four weeks. | Drug | – |
| 1018 ISSGiven 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. | Drug | – |
Primary outcome
To determine the proportion of patients who are alive and without disease progression 1 year after initiating Rituxan plus 1018 ISS therapy.
Time frame: 2 years
4 secondary outcomes
To assess the overall response rate following treatment
Time frame: 2 years
to determine duration of response and time to progression
to further define the safety profile of 1018 ISS
Time frame: 2 years
to explore the biologic activity of 1018 ISS.
Time frame: 2 years
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 29 Jan 2010.
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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.
Arnold Freedman, MD principal investigator
Dana-Farber Cancer Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rituxan and 1018 ISS in people with Non-Hodgkin's Lymphoma, run by Dana-Farber Cancer Institute at 3 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 10 inclusion and 19 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 29 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 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?
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?
To determine the proportion of patients who are alive and without disease progression 1 year after initiating Rituxan plus 1018 ISS therapy. (time frame: 2 years). 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 Jan 2010.