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
Conditions
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.
Interventions
Given IV
Given IV
Correlative studies
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Objective Response | 2 months following study treatment | Efficacy as measured by objective response complete (CR) and partial (PR) response rates at 2 months following study treatment |
Countries
United States
Participant flow
Recruitment details
Recruitment Period: January 07, 2003 to October 01, 2005. Recruitment was done at UT MD Anderson Cancer Center Clinics.
Pre-assignment details
Two participants enrolled but not assigned were not included in baseline measures. Of the total 48 participants enrolled, 42 were evaluable for response and 46 for toxicity.
Participants by arm
| Arm | Count |
|---|---|
| Oblimersen + Rituximab Oblimersen 3 mg/kg/day continuous intravenous infusion daily for 7 days on alternated weeks on week 1, 3 and 5 (days 1 through 7, 15 through 21, and 29 through 35); Rituximab 375 mg/m2 intravenous infusion for six doses on days 3, 8,15, 22, 29, and 36. | 46 |
| Total | 46 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lack of Efficacy | 1 |
| Overall Study | Physician Decision | 1 |
Baseline characteristics
| Characteristic | Oblimersen + Rituximab |
|---|---|
| Age, Continuous | 59 years |
| Region of Enrollment United States | 46 participants |
| Sex: Female, Male Female | 33 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 46 / 46 |
| serious Total, serious adverse events | 15 / 46 |
Outcome results
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
Time frame: 2 months following study treatment
Population: Analysis was per protocol. Of the 48 participants enrolled, only 42 were evaluable for response.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Oblimersen + Rituximab | Number of Patients With Objective Response | Complete Responses | 10 participants |
| Oblimersen + Rituximab | Number of Patients With Objective Response | Partial Responses | 8 participants |