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| Sponsor: | Southwest Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by (Responsible Party): | Southwest Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00080847 |
Purpose
RATIONALE: Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and prednisone, work in different ways to stop cancer cells from dividing so they stop growing or die. Oblimersen may increase the effectiveness of anticancer drugs by making cancer cells more sensitive to the drugs. Combining rituximab and combination chemotherapy with oblimersen may kill more cancer cells.
PURPOSE: This randomized phase II trial is studying rituximab and combination chemotherapy to see how well they work compared to oblimersen, rituximab, and combination chemotherapy in treating patients with advanced diffuse large B-cell non-Hodgkin's lymphoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Biological: oblimersen sodium Biological: rituximab Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: prednisone Drug: vincristine sulfate |
Phase II |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Standard Dose Cyclosphosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) And Rituximab And G3139 Phosphorothioate Oligonucleotide [Anti-BCL-2 Antisense] Therapy For Young Patients (< Age 60) With Advanced Stage Diffuse Larg B-Cell NHL Of Low And Low-Intermediate IPI Risk |
| Enrollment: | 8 |
| Study Start Date: | March 2004 |
| Study Completion Date: | July 2011 |
| Primary Completion Date: | June 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: CHOP-Rituximab and G3139 (Genasense)
8 cycles (21 days each) of the following: G3139 (genasense) 3 mg/kg/day on days 1-7, Rituximab 375 mg/m^2 on day 5, cyclophosphamide 750 mg/m^2 on day 5, doxorubicin 50 mg/m^2 on day 5, vincristine 1.4 mg/m^2 on day 5, prednisone 100 mg on days 5-10.
|
Biological: oblimersen sodium
3 mg/kg/day on days 1-7
Other Names:
Biological: rituximab
375 mg/m^2 on day 5
Drug: cyclophosphamide
750 mg/m^2 on day 5
Drug: doxorubicin hydrochloride
50 mg/m^2 on day 5
Drug: prednisone
100 mg on days 5-10
Drug: vincristine sulfate
1.4 mg/m^2 on day 5
|
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age-adjusted International Prognostic Index (0 vs 1). Patients are randomized to 1 of 2 treatment arms. (Arm I closed to accrual as of 9/21/04.)
In both arms, treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually for up to 5 years.
PROJECTED ACCRUAL: A total of 160 patients (80 per treatment arm) (arm I closed to accrual as of 9/21/04) will be accrued for this study within 2 years.
Eligibility| Ages Eligible for Study: | 18 Years to 59 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed diffuse large B-cell non-Hodgkin's lymphoma
No prior diagnosis of indolent lymphoma, including histologic transformation
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
No other malignancy within the past 5 years except any of the following:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations More Information
| Responsible Party: | Southwest Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00080847 History of Changes |
| Other Study ID Numbers: | CDR0000356049, U10CA032102, S0349 |
| Study First Received: | April 7, 2004 |
| Last Updated: | January 11, 2012 |
| Health Authority: | United States: Federal Government; United States: Food and Drug Administration |
|
contiguous stage II adult diffuse large cell lymphoma noncontiguous stage II adult diffuse large cell lymphoma stage III adult diffuse large cell lymphoma stage IV adult diffuse large cell lymphoma |
|
Lymphoma Lymphoma, Non-Hodgkin Lymphoma, B-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Cyclophosphamide Rituximab Doxorubicin Prednisone Vincristine Immunosuppressive Agents |
Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antibiotics, Antineoplastic Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal |
