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Rituximab Followed by Combination Chemotherapy in Treating Patients With Refractory or Recurrent Non-Hodgkin's Lymphoma Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Rituximab Followed by Combination Chemotherapy in Treating Patients With Refractory or Recurrent Non-Hodgkin's Lymphoma conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Rituximab Followed by Combination Chemotherapy in Treating Patients With Refractory or Recurrent Non-Hodgkin's Lymphoma Clinical research trials and Rituximab Followed by Combination Chemotherapy in Treating Patients With Refractory or Recurrent Non-Hodgkin's Lymphoma medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Rituximab Followed by Combination Chemotherapy in Treating Patients With Refractory or Recurrent Non-Hodgkin's Lymphoma. Rituximab Followed by Combination Chemotherapy in Treating Patients With Refractory or Recurrent Non-Hodgkin's Lymphoma Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Rituximab Followed by Combination Chemotherapy in Treating Patients With Refractory or Recurrent Non-Hodgkin's Lymphoma clinical trial. Participants oftentimes recieve the finest healthcare available for their Rituximab Followed by Combination Chemotherapy in Treating Patients With Refractory or Recurrent Non-Hodgkin's Lymphoma condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "R" Clinical Trials Conditions > Rituximab Followed by Combination Chemotherapy in Treating Patients With Refractory or Recurrent Non-Hodgkin's Lymphoma  Rituximab Followed by Combination Chemotherapy in Treating Patients With Refractory or Recurrent Non-Hodgkin's Lymphoma
Rituximab Followed by Combination Chemotherapy in Treating Patients With Refractory or Recurrent Non-Hodgkin's Lymphoma
For Condition: recurrent adult diffuse mixed cell lymphoma,recurrent adult diffuse small cleaved cell lymphoma,recurrent grade III follicular large cell lymphoma,recurrent adult diffuse large cell lymphoma
Status: No longer recruiting
Sponsor(s): Washington Hospital Center ,
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 use different ways to kill cancer cells. Combining monoclonal antibody therapy with chemotherapy may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of rituximab followed by combination chemotherapy in treating patients who have refractory or recurrent non-Hodgkin's lymphoma.
Details: OBJECTIVES: I. Determine the response rate in patients with refractory or recurrent CD20+ intermediate grade B-cell non-Hodgkin's lymphoma treated with rituximab followed by etoposide, vincristine, doxorubicin, cyclophosphamide, and prednisone (EPOCH). II. Determine the toxicity of the regimen in these patients. PROTOCOL OUTLINE: This is a multicenter study. Patients receive rituximab IV over 4-10 hours on day 1 followed by etoposide, vincristine, and doxorubicin IV continuously on days 4-7, cyclophosphamide IV over 5-30 minutes on day 8 and oral prednisone on days 4-8. Patients also receive sargramostim (GM-CSF) subcutaneously beginning on day 9 until blood counts recover. Treatment repeats every 21 days for a maximum of 8 courses in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Diagnosis of intermediate grade B-cell CD20+ non-Hodgkin's lymphoma; Failed to achieve initial complete response (CR) after at least 2 courses of standard chemotherapy OR Relapsed after CR and not eligible for autologous bone marrow transplant - Measurable disease defined as one of the following: Bidimensionally measurable disease at least 2 cm in diameter by radiograph or CT scan; Enlarged spleen extending at least 2 cm below the costal due to lymphomatous involvement; Enlarged liver with focal lesions on CT scan or biopsy proven lesions; Lymphomatous hepatic involvement must be biopsy proven for the liver to be sole area of measurable disease - No evidence of CNS involvement [A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.] --Prior/Concurrent Therapy-- - See Disease Characteristics; No prior rituximab --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-3 - Life expectancy: Not specified - Hematopoietic: Absolute neutrophil count at least 1,500/mm3*; Platelet count at least 100,000/mm3* *unless there is bone marrow involvement with lymphoma - Hepatic: Bilirubin less than 3 mg/dL; AST/ALT less than 2 times normal - Renal: Creatinine less than 2.1 mg/dL OR Creatinine clearance greater than 60 mL/min - Cardiovascular: LVEF greater than 45% by MUGA or echocardiogram - Other: No prior malignancy within the past 10 years except squamous cell carcinoma or basal cell carcinoma of the skin or cervical cancer ;No evidence of infection; HIV negative; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
SeinAung, Study Chair, Washington Hospital Center
Franklin Square Hospital Center
Baltimore, Maryland, 21237
United States
Washington Cancer Institute
Washington D.C., District of Columbia, 20010
United States
Additional Information:
Study ID Numbers: CDR0000068283; NCI-V00-1630,WHC-99365
Study Start Date: September 1999
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006669
Other Recurrent Adult Diffuse Large Cell Lymphoma Studies:
1. Combination Chemotherapy and Radiation Therapy Plus Bone Marrow Transplantation in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
2. Etoposide in Treating Patients With Relapsed Non-Hodgkin's Lymphoma
3. BAY 59-8862 in Treating Patients With Refractory Non-Hodgkin's Lymphoma
4. Peripheral Stem Cell Transplantation Following Radiation Therapy in Treating Patients With Hodgkin's Disease or Non-Hodgkin's Lymphoma
5. Monoclonal Antibody Therapy in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Related Studies:
Other recurrent adult diffuse large cell lymphoma Clinical Trials
Other District of Columbia Clinical Trials
Other Washington D.C. Clinical Trials
Rituximab Followed by Combination Chemotherapy in Treating Patients With Refractory or Recurrent Non-Hodgkin's Lymphoma
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