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Oblimersen, Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Treating Patients With Stage II, Stage III, or Stage IV Diffuse Large B-Cell Lymphoma Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Oblimersen, Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Treating Patients With Stage II, Stage III, or Stage IV Diffuse Large B-Cell Lymphoma conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Oblimersen, Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Treating Patients With Stage II, Stage III, or Stage IV Diffuse Large B-Cell Lymphoma Clinical research trials and Oblimersen, Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Treating Patients With Stage II, Stage III, or Stage IV Diffuse Large B-Cell Lymphoma healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Oblimersen, Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Treating Patients With Stage II, Stage III, or Stage IV Diffuse Large B-Cell Lymphoma. Oblimersen, Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Treating Patients With Stage II, Stage III, or Stage IV Diffuse Large B-Cell Lymphoma Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Oblimersen, Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Treating Patients With Stage II, Stage III, or Stage IV Diffuse Large B-Cell Lymphoma clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Oblimersen, Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Treating Patients With Stage II, Stage III, or Stage IV Diffuse Large B-Cell Lymphoma condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "O" Clinical Trials Conditions > Oblimersen, Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Treating Patients With Stage II, Stage III, or Stage IV Diffuse Large B-Cell Lymphoma  Oblimersen, Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Treating Patients With Stage II, Stage III, or Stage IV Diffuse Large B-Cell Lymphoma
Oblimersen, Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Treating Patients With Stage II, Stage III, or Stage IV Diffuse Large B-Cell Lymphoma
For Condition: noncontiguous stage 2 adult diffuse large cell lymphoma,stage 4 adult diffuse large cell lymphoma,contiguous stage 2 adult diffuse large cell lymphoma,stage 3 adult diffuse large cell lymphoma
Status: Recruiting
Sponsor(s): British Columbia Cancer Agency , National Cancer Institute (NCI)
Synopsis: 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, use different ways to stop cancer cells from dividing so they stop growing or die. Oblimersen may increase the effectiveness of a chemotherapy drug by making cancer cells more sensitive to the drug. Combining oblimersen with rituximab and combination chemotherapy may kill more cancer cells. PURPOSE: Phase I trial to study the effectiveness of combining oblimersen with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone in treating patients who have stage II, stage III, or stage IV large B-cell lymphoma
Details: OBJECTIVES: Primary - Determine the feasibility and safety of oblimersen administered in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone, in terms of short-term and long-term toxicity, in patients with previously untreated stage III or IV or extensive or bulky stage II diffuse large B-cell lymphoma. - Determine the maximum tolerated dose of oblimersen administered with this regimen in these patients. Secondary - Determine the remission rate and failure-free, progression-free, and overall survival of patients treated with this regimen. OUTLINE: This is a nonrandomized, non-blinded, multicenter, dose-escalation study of oblimersen. Patients receive CHOP-R* therapy comprising cyclophosphamide IV over 15-45 minutes, doxorubicin IV over 5-10 minutes, vincristine IV, and rituximab IV over 30-90 minutes on day 1 and oral prednisone on days 1-5. Patients also receive oblimersen IV continuously on days -4 to 3. Treatment repeats every 21 days for 6-8 courses in the absence of disease progression or unacceptable toxicity. Patients who discontinue treatment due to unacceptable toxicity to oblimersen may continue to receive standard therapy comprising CHOP-R. NOTE: *Patients treated at the British Columbia Cancer Agency receive cyclophosphamide, doxorubicin, vincristine, and rituximab on days 1 and 2 and prednisone as above. Cohorts of 3-6 patients receive escalating doses of oblimersen until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, at least 10 patients are treated at that dose level. Patients are followed every 3 months for 2 years, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 19-28 patients will be accrued for this study within 5-10 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 19 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed* CD20+ diffuse large B-cell lymphoma, including any of the following stages: - Extensive stage II (not radio-encompassable within a single involved field or not a candidate for brief chemotherapy and radiotherapy) - Bulky stage II (any single mass greater than 10 cm) - Stage III - Stage IV NOTE: *Confirmed by tissue biopsy - Previously untreated disease - Measurable disease - At least 2 cm by imaging studies - Circulating lymphoma cells no greater than 5,000/mm^3 - No history of other lymphoproliferative disorder - No history of indolent lymphoma - No T-cell lymphoma - No CNS involvement - No post-transplantation lymphoproliferative disorder PATIENT CHARACTERISTICS: Age - 19 and over Performance status - ECOG 0-2 Life expectancy - Not specified Hematopoietic - Absolute neutrophil count at least 1,500/mm^3 (unless due to bone marrow involvement with lymphoma) - Platelet count at least 100,000/mm^3 (unless due to splenomegaly or bone marrow involvement with lymphoma) Hepatic - Bilirubin no greater than 3 mg/dL (unless due to lymphoma) - No known hepatitis B virus Renal - Creatinine no greater than 2 mg/dL (unless due to lymphoma) Cardiovascular - No cardiac contraindication to doxorubicin therapy (e.g., abnormal contractility on echocardiography) - History of cardiac disease allowed provided ejection fraction is normal Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - Adequate venous access - HIV negative - No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer, localized basal cell or squamous cell skin cancer, or curatively treated carcinoma in situ of the cervix - No neurological contraindication to vincristine (e.g., peripheral neuropathy) - No active systemic infection - No medical condition that would compromise study treatment, add toxicity, or impair assessment PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No prior systemic chemotherapy Endocrine therapy - Not specified Radiotherapy - No prior radiotherapy - Prior radiotherapy for localized basal cell or squamous cell skin cancer used with curative intent allowed Surgery - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RichardKlasa, Study Chair, British Columbia Cancer Agency
British Columbia Cancer Agency - Centre for the Southern Interior *Recruiting*
Kelowna, British Columbia, V1Y 5L3
Canada
Recruiting Judith Sutherland 250-712-3900
Fraser Valley Cancer Centre at British Columbia Cancer Agency *Recruiting*
Surrey, British Columbia, V3V 1Z2
Canada
Recruiting Karamjit Gill 604-930-4064
British Columbia Cancer Agency *Recruiting*
Vancouver, British Columbia, V5Z 4E6
Canada
Recruiting Richard Klasa 604-877-6000 ext. 2730
Stanford Cancer Center at Stanford University Medical Center *Recruiting*
Stanford, California, 94305
United States
Recruiting Sandra Horning 650-725-6456
Additional Information:
Study ID Numbers: CDR0000329985; BCCA-NCI-5818,NCI-5818
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00070083
Other Stage 3 Adult Diffuse Large Cell Lymphoma Studies:
1. Chemotherapy and Rituximab With or Without Total-Body Irradiation and Peripheral Stem Cell Transplantation in Treating Patients With Lymphoma
2. Combination Chemotherapy With or Without Rituximab in Treating Patients With Non-Hodgkin's Lymphoma
3. Combination Chemotherapy and Monoclonal Antibody Therapy in Treating Older Patients With Previously Untreated Non-Hodgkin's Lymphoma
4. Rituximab and Combination Chemotherapy Combined With Yttrium Y 90 Ibritumomab Tiuxetan in Treating Older Patients With Previously Untreated B-Cell Lymphoma
5. Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone With or Without Oblimersen in Treating Patients With Advanced Diffuse Large B-Cell Non-Hodgkin's Lymphoma
Related Studies:
Other stage 3 adult diffuse large cell lymphoma Clinical Trials
Other British Columbia Clinical Trials
Other Surrey Clinical Trials
Oblimersen, Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Treating Patients With Stage II, Stage III, or Stage IV Diffuse Large B-Cell Lymphoma
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