Rituximab and Oblimersen in Treating Patients With Stage II, Stage III, or Stage IV Follicular Non-Hodgkin's Lymphoma

Part of paid clinical trials in Chicago, Illinois.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00301795
Phase
PHASE2
Status
Terminated

Conditions

  • Stage III Grade 1 Follicular Lymphoma
  • Stage III Grade 2 Follicular Lymphoma
  • Stage III Grade 3 Follicular Lymphoma
  • Stage IV Grade 1 Follicular Lymphoma
  • Stage IV Grade 2 Follicular Lymphoma
  • Stage IV Grade 3 Follicular Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • oblimersen sodium — BIOLOGICAL
    Given IV
  • rituximab — BIOLOGICAL
    Given IV
  • laboratory biomarker analysis — OTHER
    Correlative studies

Study Details

Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Oblimersen may help rituximab work better by making cancer cells more sensitive to the drug. This phase II trial is studying how well giving rituximab together with oblimersen works in treating patients with stage II, stage III, or stage IV follicular non-Hodgkin's lymphoma

Key Dates

Start date
Mar 31, 2006
Status verified
Jan 2013
Primary completion
Nov 30, 2007

Study Design

Enrollment
52 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (oblimersen sodium and rituximab)
    Induction therapy (month 1): Patients receive oblimersen IV continuously on days 1-7 and 15-21 and rituximab IV on days 3, 10, 17, and 24 in month 1. Extended induction therapy (months 3, 5, 7, and 9): Patients receive oblimersen IV continuously on days 22-28 and rituximab IV on day 24 in months 3, 5, 7, and 9. Treatment continues for 9 months in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Overall response (OR) rate defined as achievement of a complete (CR) or partial response (PR) as the best observed response [ Time Frame: 12 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Cancer and Leukemia Group BChicagoIllinois60606-

Find similar trials in Chicago, IL

By research site
Cancer and Leukemia Group B· Chicago, IL