NCT00251394

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2004

Longer than P75 for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 8, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 10, 2005

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

January 29, 2010

Status Verified

July 1, 2009

Enrollment Period

2.4 years

First QC Date

November 8, 2005

Last Update Submit

January 28, 2010

Conditions

Non-Hodgkin's Lymphoma

Keywords

B-Cell follicular non-Hodgkin's lymphomaRituxanRituximab1018 ISSCD 20 +

Outcome Measures

Primary Outcomes (1)

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

    2 years

Secondary Outcomes (4)

  • To assess the overall response rate following treatment

    2 years

  • to determine duration of response and time to progression

  • to further define the safety profile of 1018 ISS

    2 years

  • to explore the biologic activity of 1018 ISS.

    2 years

Interventions

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

Rituximab1018 oligonucleotide

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Arnold Freedman, MD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 8, 2005

First Posted

November 10, 2005

Study Start

July 1, 2004

Primary Completion

December 1, 2006

Study Completion

July 1, 2009

Last Updated

January 29, 2010

Record last verified: 2009-07

Locations

US(3)