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.
18 Years
N/A
Both
Non-Hodgkin's Lymphoma
Trial Information
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.
- 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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To determine the proportion of patients who are alive and without disease progression 1 year after initiating Rituxan plus 1018 ISS therapy.
Outcome Time Frame:
2 years
Safety Issue:
No
Principal Investigator
Arnold Freedman, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Dana-Farber Cancer Institute
Authority:
United States: Food and Drug Administration
Study ID:
03-411
NCT ID:
NCT00251394
Start Date:
July 2004
Completion Date:
July 2009
Related Keywords:
- Non-Hodgkin's Lymphoma
- B-Cell follicular non-Hodgkin's lymphoma
- Rituxan
- Rituximab
- 1018 ISS
- CD 20 +
- Lymphoma
- Lymphoma, Follicular
- Lymphoma, Non-Hodgkin
Name | Location |
|---|---|
| Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
| Brigham and Women's Hospital | Boston, Massachusetts 02115 |
| Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
