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Molecular Risk Assessment in Planning Treatment for Patients With Non-Hodgkin's Lymphoma Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Molecular Risk Assessment in Planning Treatment for Patients With Non-Hodgkin's Lymphoma conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Molecular Risk Assessment in Planning Treatment for Patients With Non-Hodgkin's Lymphoma Clinical research trials and Molecular Risk Assessment in Planning Treatment for Patients With Non-Hodgkin's Lymphoma health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Molecular Risk Assessment in Planning Treatment for Patients With Non-Hodgkin's Lymphoma. Molecular Risk Assessment in Planning Treatment for Patients With Non-Hodgkin's Lymphoma Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Molecular Risk Assessment in Planning Treatment for Patients With Non-Hodgkin's Lymphoma clinical trial. Test subjects typically receive the most expert healthcare available for their Molecular Risk Assessment in Planning Treatment for Patients With Non-Hodgkin's Lymphoma condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "M" Clinical Trials Conditions > Molecular Risk Assessment in Planning Treatment for Patients With Non-Hodgkin's Lymphoma  Molecular Risk Assessment in Planning Treatment for Patients With Non-Hodgkin's Lymphoma
Molecular Risk Assessment in Planning Treatment for Patients With Non-Hodgkin's Lymphoma
For Condition: childhood diffuse large cell lymphoma,adult diffuse large cell lymphoma,childhood large cell lymphoma
Status: Recruiting
Sponsor(s): Ireland Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Analyzing genes that are present in cancer cells may be useful as a method for predicting the response of non-Hodgkin's lymphoma to cancer treatment. Imaging procedures such as positron emission tomography (PET) scans may improve the ability to measure how well cancer has responded to treatment. PURPOSE: Phase II trial to study the effectiveness of molecular risk assessment in predicting response to therapy in patients who are receiving treatment for non-Hodgkin's lymphoma.
Details: OBJECTIVES: - Determine whether molecular risk assessment can identify groups of patients with diffuse large B-cell non-Hodgkin's lymphoma (NHL) who will demonstrate at least 50% difference in early response rates to treatment as determined by positron-emission tomography (PET) imaging. - Determine, by PET imaging, the response rate of patients treated with cyclophosphamide, doxorubicin, vincristine, prednisone, and rituximab. - Determine whether early response rates can be predicted by gene expression profiles at diagnosis in these patients. - Compare gene expression profiles of patients with refractory or relapsed large cell NHL with profiles of the disease at diagnosis. - Determine relapse-free and overall survival rates of these patients. - Determine the feasibility of a new NHL treatment algorithm based on prognostic index and molecular risk, and early response assessment by PET imaging. OUTLINE: Molecular risk assessment is performed using lymph node tissue from initial diagnosis to test for "activated" genes before starting treatment. Patients receive rituximab IV over 3-6 hours, cyclophosphamide IV over 30 minutes, doxorubicin IV over 5 minutes, and vincristine IV over 5 minutes on day 1 and oral prednisone on days 1-5. Treatment repeats every 21 days for 3-8 courses. Patients undergo whole-body positron-emission tomography (PET) scanning at baseline and after course 3 to determine response. Results from the genetic testing and PET scans are used to determine further treatment recommendations. Patients are followed every 3 months for 1 year and then every 6 months for 2 years. PROJECTED ACCRUAL: A total of 36-50 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed diffuse large B-cell non-Hodgkin's lymphoma - CD20 and/or CD19 positive by immunohistochemistry or flow cytometry - Disease evaluable by positron-emission tomography scan - Diagnostic tissue (either frozen or fresh unfixed) available for molecular testing or willing to undergo a repeat procedure to obtain such tissue - No CNS involvement by lymphoma PATIENT CHARACTERISTICS: Age - Not specified Performance status - Not specified Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Bilirubin no greater than 3 mg/dL Renal - Creatinine no greater than 3 mg/dL Cardiovascular - LVEF at least 40% Other - Not pregnant or nursing - Fertile patients must use effective contraception - No significant organ dysfunction that would preclude study chemotherapy - HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy - No prior immunotherapy - No prior biological response modifier therapy Chemotherapy - No prior chemotherapy Endocrine therapy - Not specified Radiotherapy - No prior radiotherapy - No prior radioimmunotherapy Surgery - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
OmerKoc, Study Chair, Ireland Cancer Center
Ireland Cancer Center *Recruiting*
Cleveland, Ohio, 44106
United States
Recruiting Omer Koc 216-244-1274
Additional Information:
Study ID Numbers: CDR0000269929; CWRU-1402,CWRU-060244
Study Start Date:
Record last reviewed: February 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00055640
Other Adult Diffuse Large Cell Lymphoma Studies:
1. Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone With or Without Gemcitabine in Treating Patients With Previously Untreated Aggressive Non-Hodgkin’s Lymphoma
2. Chemoradiotherapy and Peripheral Stem Cell Transplantation Compared With Combination Chemotherapy in Treating Patients With Non-Hodgkin's Lymphoma
3. Combination Chemotherapy and Monoclonal Antibody Therapy in Treating Patients With Non-Hodgkin's Lymphoma
4. Combination Chemotherapy Plus Filgrastim With or Without Rituximab in Treating Older Patients With Non-Hodgkin's Lymphoma
5. Combination Chemotherapy in Treating Patients With Aggressive Non-Hodgkin's Lymphoma
Related Studies:
Other adult diffuse large cell lymphoma Clinical Trials
Other Ohio Clinical Trials
Other Cleveland Clinical Trials
Molecular Risk Assessment in Planning Treatment for Patients With Non-Hodgkin's Lymphoma
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