Oblimersen Sodium and Rituximab in Treating Patients With Recurrent B-cell Non-Hodgkin Lymphoma
This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00054639
First received: February 5, 2003
Last updated: March 11, 2013
Last verified: March 2013
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
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 |
Biological: oblimersen sodium Biological: rituximab Other: laboratory biomarker analysis |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of G3139 (Bcl-2 Antisense) And Rituximab in Patients With Recurrent B-cell Non-Hodgkinâs Lymphomas |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Number of Patients With Objective Response [ Time Frame: 2 months following study treatment ] [ Designated as safety issue: No ]Efficacy as measured by objective response complete (CR) and partial (PR) response rates at 2 months following study treatment
| Enrollment: | 120 |
| Study Start Date: | January 2003 |
| Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment (oblimersen sodium and monoclonal antibody therapy)
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.
|
Biological: oblimersen sodium
Given IV
Other Names:
Biological: rituximab
Given IV
Other Names:
Other: laboratory biomarker analysis
Correlative studies
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00054639 History of Changes |
| Obsolete Identifiers: | NCT01654952 |
| Other Study ID Numbers: | NCI-2011-00617, ID02-148, N01CM17003, N01CM62202, N01CM17107, N01CM62203 |
| Study First Received: | February 5, 2003 |
| Results First Received: | January 24, 2011 |
| Last Updated: | March 11, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Burkitt Lymphoma Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphomatoid Granulomatosis Waldenstrom Macroglobulinemia Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Large-Cell, Immunoblastic Precursor Cell Lymphoblastic Leukemia-Lymphoma Lymphoma, B-Cell, Marginal Zone Lymphoma, Extranodal NK-T-Cell Lymphoma, Mantle-Cell Epstein-Barr Virus Infections |
Herpesviridae Infections DNA Virus Infections Virus Diseases Tumor Virus Infections Neoplasms by Histologic Type Neoplasms Neoplasms, Experimental Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Leukemia, B-Cell Leukemia, Lymphoid Leukemia Precancerous Conditions |
ClinicalTrials.gov processed this record on May 19, 2013