Clinical Trials Directory

Trials / Terminated

TerminatedNCT00736450

Oblimersen Sodium & Combination Chemotherapy in Treating Patients With Newly Diagnosed Diffuse Large B-Cell Lymphoma

Investigator Initiated Pilot Study of Microarray Directed Therapy for Diffuse Large B-cell Lymphoma Using Genasense With CHOP-R

Status
Terminated
Phase
EARLY_Phase 1
Study type
Interventional
Enrollment
37 (actual)
Sponsor
University of Nebraska · Academic / Other
Sex
All
Age
19 Years
Healthy volunteers
Not accepted

Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Oblimersen sodium may help chemotherapy work better by making cancer cells more sensitive to the drugs. Giving oblimersen sodium together with combination chemotherapy may kill more cancer cells. PURPOSE: This clinical trial is studying the side effects of giving oblimersen sodium together with combination chemotherapy and to see how well it works in treating patients with newly diagnosed stage I, stage II, stage III, or stage IV diffuse large B-cell lymphoma

Detailed description

PRIMARY OBJECTIVES: I. To assess the feasibility and determine the rate of rapid turn around, that is within 7 working days of receipt of adequate tissue at UNMC for a AFFYmetrix microarray study of newly diagnosed patients with Diffuse Large B-cell Lymphoma (DLBCL) who will then receive treatment on this protocol. II. To evaluate efficacy (complete response rate) of Genasense (antisense bcl-2) given in addition to standard cyclophosphamide, vincristine, doxorubicin, and prednisone -rituximab (CHOP-R) to newly diagnosed patients with DLBCL who are found to have the ABC type after gene expression profiling or IHC as compared to newly diagnosed patients with DLBCL who do not express the ABC type that go on to receive standard CHOP-R (control). III. To evaluate the toxicity of Genasense (antisense bcl-2) given in addition to standard cyclophosphamide, vincristine, doxorubicin, and prednisone -rituximab (CHOP-R) for newly diagnosed patients with DLBCL who are found to have the ABC type after gene expression profiling. OUTLINE: Patients with diffuse large B-cell lymphoma (DLBCL) that expresses ABC type proceed to treatment in group I. Patients with DLBCL that does not express ABC type proceed to treatment in group II. GROUP I (oblimersen sodium and standard CHOP-R): Patients receive oblimersen sodium IV continuously on days 1-7. Patients also receive CHOP-R comprising rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 5 and prednisone orally on days 5-10. Treatment repeats every 3 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity. GROUP II (standard CHOP-R alone): Patients receive CHOP-R comprising rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 1 and prednisone orally on days 1-5. Treatment repeats every 3 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed periodically.

Conditions

Interventions

TypeNameDescription
BIOLOGICALoblimersen sodiumGiven IV
BIOLOGICALrituximabGiven IV
DRUGcyclophosphamideGiven IV
DRUGdoxorubicin hydrochlorideGiven IV
DRUGvincristine sulfateGiven IV
DRUGprednisoneGiven orally
PROCEDUREbiopsyCorrelative studies
GENETICmicroarray analysisCorrelative studies
OTHERimmunohistochemistry staining methodCorrelative studies
GENETICgene expression analysisCorrelative studies
GENETICcytogenetic analysisCorrelative studies

Timeline

Start date
2008-07-23
Primary completion
2012-10-09
Completion
2012-10-09
First posted
2008-08-15
Last updated
2023-10-24
Results posted
2018-08-31

Locations

2 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT00736450. Inclusion in this directory is not an endorsement.