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Oblimersen Sodium and Rituximab in Treating Patients With Recurrent B-cell Non-Hodgkin Lymphoma

Primary Purpose

Cutaneous B-cell Non-Hodgkin Lymphoma, Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Intraocular Lymphoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
oblimersen sodium
rituximab
laboratory biomarker analysis
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cutaneous B-cell Non-Hodgkin Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Must have recurrent B-cell NHL and measurable disease No anti-lymphoma therapy within the past 4 weeks Must have a good performance status (less than or equal to 2 Zubrod, greater than or equal to 60 Karnofsky) Absolute neutrophil count (ANC) greater than or equal to 1,000 Platelets greater than or equal to 75,000 Hemoglobin greater than or equal to 10 g/dL Bilirubin less than or equal to 1.5 mg/dL Serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvate transaminase (SGPT) less than or equal to 2 times upper limit of laboratory normals Alkaline phosphatase less than or equal to 2 times upper limit of laboratory normals Serum creatinine less than or equal to 1.8 mg/dL Must sign a consent form, and must have a life expectancy of greater than 12 weeks No more than 3 prior chemotherapy regimens Patients who are either Rituximab naive, have previously responded to Rituximab, or are refractory to Rituximab used alone or in combination with chemotherapy Exclusion Criteria: Human immunodeficiency virus (HIV) positive Active infection or history of opportunistic infections Pregnant women and women of childbearing age who are not practicing adequate contraception; men who are not willing to use an effective method of contraception History of second cancer (except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer or other cancer for which the patient has been disease-free for 5 or more years) Active autoimmune disease Other significant medical diseases Patients with chronic lymphocytic leukemia (CLL) Prior exposure to G3139

Sites / Locations

  • M D Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (oblimersen sodium and monoclonal antibody therapy)

Arm Description

Patients receive oblimersen sodium IV continuously on days 1-7, 15-21, and 29-35 and rituximab IV over 4-6 hours on days 3, 8, 15, 22, 29, and 36. Patients achieving stable disease or objective response may receive one additional course of treatment.

Outcomes

Primary Outcome Measures

Number of Patients With Objective Response
Efficacy as measured by objective response complete (CR) and partial (PR) response rates at 2 months following study treatment

Secondary Outcome Measures

Full Information

First Posted
February 5, 2003
Last Updated
May 13, 2014
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00054639
Brief Title
Oblimersen Sodium and Rituximab in Treating Patients With Recurrent B-cell Non-Hodgkin Lymphoma
Official Title
A Phase II Study of G3139 (Bcl-2 Antisense) And Rituximab in Patients With Recurrent B-cell Non-Hodgkinâs Lymphomas
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
The goal of this clinical research study is to learn if the combination of oblimersen sodium and rituximab can help to shrink or slow the growth of the tumor in patients with B-cell non-Hodgkin's lymphoma who have not responded to earlier treatment. Oblimersen Sodium is an investigational drug. The safety of this combination treatment will also be studied
Detailed Description
PRIMARY OBJECTIVES: I. To determine the therapeutic efficacy and toxicity of G3139 (oblimersen sodium) and Rituximab in patients with recurrent B-cell NHL. SECONDARY OBJECTIVES: I. To determine the effect of G3139 and Rituximab on the level of Bcl-2 expression. II. The secondary objective of this study is to evaluate the effect of G3139 and Rituximab on Bcl-2 protein gene expression. OUTLINE: Patients receive oblimersen sodium intravenously (IV) continuously on days 1-7, 15-21, and 29-35 and rituximab IV over 4-6 hours on days 3, 8, 15, 22, 29, and 36. Patients achieving stable disease or objective response may receive one additional course of treatment. After completion of study treatment, patients are followed up every 3 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cutaneous B-cell Non-Hodgkin Lymphoma, Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Intraocular Lymphoma, Nodal Marginal Zone B-cell Lymphoma, Recurrent Adult Burkitt Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Adult Diffuse Mixed Cell Lymphoma, Recurrent Adult Diffuse Small Cleaved Cell Lymphoma, Recurrent Adult Grade III Lymphomatoid Granulomatosis, Recurrent Adult Immunoblastic Large Cell Lymphoma, Recurrent Adult Lymphoblastic Lymphoma, Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Grade 3 Follicular Lymphoma, Recurrent Mantle Cell Lymphoma, Recurrent Marginal Zone Lymphoma, Recurrent Small Lymphocytic Lymphoma, Small Intestine Lymphoma, Splenic Marginal Zone Lymphoma, Testicular Lymphoma, Waldenström Macroglobulinemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (oblimersen sodium and monoclonal antibody therapy)
Arm Type
Experimental
Arm Description
Patients receive oblimersen sodium IV continuously on days 1-7, 15-21, and 29-35 and rituximab IV over 4-6 hours on days 3, 8, 15, 22, 29, and 36. Patients achieving stable disease or objective response may receive one additional course of treatment.
Intervention Type
Biological
Intervention Name(s)
oblimersen sodium
Other Intervention Name(s)
augmerosen, G3139, G3139 bcl-2 antisense oligodeoxynucleotide, Genasense
Intervention Description
Given IV
Intervention Type
Biological
Intervention Name(s)
rituximab
Other Intervention Name(s)
IDEC-C2B8, IDEC-C2B8 monoclonal antibody, Mabthera, MOAB IDEC-C2B8, Rituxan
Intervention Description
Given IV
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Number of Patients With Objective Response
Description
Efficacy as measured by objective response complete (CR) and partial (PR) response rates at 2 months following study treatment
Time Frame
2 months following study treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Must have recurrent B-cell NHL and measurable disease No anti-lymphoma therapy within the past 4 weeks Must have a good performance status (less than or equal to 2 Zubrod, greater than or equal to 60 Karnofsky) Absolute neutrophil count (ANC) greater than or equal to 1,000 Platelets greater than or equal to 75,000 Hemoglobin greater than or equal to 10 g/dL Bilirubin less than or equal to 1.5 mg/dL Serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvate transaminase (SGPT) less than or equal to 2 times upper limit of laboratory normals Alkaline phosphatase less than or equal to 2 times upper limit of laboratory normals Serum creatinine less than or equal to 1.8 mg/dL Must sign a consent form, and must have a life expectancy of greater than 12 weeks No more than 3 prior chemotherapy regimens Patients who are either Rituximab naive, have previously responded to Rituximab, or are refractory to Rituximab used alone or in combination with chemotherapy Exclusion Criteria: Human immunodeficiency virus (HIV) positive Active infection or history of opportunistic infections Pregnant women and women of childbearing age who are not practicing adequate contraception; men who are not willing to use an effective method of contraception History of second cancer (except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer or other cancer for which the patient has been disease-free for 5 or more years) Active autoimmune disease Other significant medical diseases Patients with chronic lymphocytic leukemia (CLL) Prior exposure to G3139
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara Pro
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Oblimersen Sodium and Rituximab in Treating Patients With Recurrent B-cell Non-Hodgkin Lymphoma

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