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

Dana-Farber Cancer Institute

Status and phase

Completed

Phase 2

Conditions

Non-Hodgkin's Lymphoma

Treatments

Drug: 1018 ISS

Drug: Rituxan

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00251394

R21

U10402

03-411

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No 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