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Study of Dynavax's 1018 ISS, Following Rituxan in Patients With B-Cell Follicular Lymphoma

Primary Purpose

Non-Hodgkin's Lymphoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Rituxan
1018 ISS
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Hodgkin's Lymphoma focused on measuring B-Cell follicular non-Hodgkin's lymphoma, Rituxan, Rituximab, 1018 ISS, CD 20 +

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 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: 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 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

Sites / Locations

  • Massachusetts General Hospital
  • Brigham and Women's Hospital
  • Dana-Farber Cancer Institute

Outcomes

Primary Outcome Measures

To determine the proportion of patients who are alive and without disease progression 1 year after initiating Rituxan plus 1018 ISS therapy.

Secondary Outcome Measures

To assess the overall response rate following treatment
to determine duration of response and time to progression
to further define the safety profile of 1018 ISS
to explore the biologic activity of 1018 ISS.

Full Information

First Posted
November 8, 2005
Last Updated
January 28, 2010
Sponsor
Dana-Farber Cancer Institute
Collaborators
Dynavax Technologies Corporation, James P. Wilmot Cancer Center, University of Rochester, Brigham and Women's Hospital, Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00251394
Brief Title
Study of Dynavax's 1018 ISS, Following Rituxan in Patients With B-Cell Follicular Lymphoma
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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
Dynavax Technologies Corporation, James P. Wilmot Cancer Center, University of Rochester, Brigham and Women's Hospital, Massachusetts General Hospital

4. Oversight

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin's Lymphoma
Keywords
B-Cell follicular non-Hodgkin's lymphoma, Rituxan, Rituximab, 1018 ISS, CD 20 +

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Rituxan
Intervention Description
Given intravenously once weekly for four weeks.
Intervention Type
Drug
Intervention Name(s)
1018 ISS
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
To assess the overall response rate following treatment
Time Frame
2 years
Title
to determine duration of response and time to progression
Title
to further define the safety profile of 1018 ISS
Time Frame
2 years
Title
to explore the biologic activity of 1018 ISS.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arnold Freedman, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Study of Dynavax's 1018 ISS, Following Rituxan in Patients With B-Cell Follicular Lymphoma

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