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Combination Chemotherapy in Treating Patients With Newly Diagnosed Mantle Cell Lymphoma Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Combination Chemotherapy in Treating Patients With Newly Diagnosed Mantle Cell Lymphoma conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Combination Chemotherapy in Treating Patients With Newly Diagnosed Mantle Cell Lymphoma Clinical research trials and Combination Chemotherapy in Treating Patients With Newly Diagnosed Mantle Cell Lymphoma healthcare trials occur in a lot of 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 does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Combination Chemotherapy in Treating Patients With Newly Diagnosed Mantle Cell Lymphoma. Combination Chemotherapy in Treating Patients With Newly Diagnosed Mantle Cell Lymphoma Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Combination Chemotherapy in Treating Patients With Newly Diagnosed Mantle Cell Lymphoma clinical trial. Test subjects typically receive the most effective healthcare possible for their Combination Chemotherapy in Treating Patients With Newly Diagnosed Mantle Cell Lymphoma condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy in Treating Patients With Newly Diagnosed Mantle Cell Lymphoma  Combination Chemotherapy in Treating Patients With Newly Diagnosed Mantle Cell Lymphoma
Combination Chemotherapy in Treating Patients With Newly Diagnosed Mantle Cell Lymphoma
For Condition: stage 4 mantle cell lymphoma,stage 1 mantle cell lymphoma,contiguous stage 2 mantle cell lymphoma,noncontiguous stage 2 mantle cell lymphoma,stage 3 mantle cell lymphoma
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , M.D. Anderson Cancer Center
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of different regimens of combination chemotherapy in treating patients with newly diagnosed mantle cell lymphoma.
Details: OBJECTIVES: I. Evaluate the complete response rate and duration of response in patients with newly diagnosed diffuse or nodular mantle cell lymphoma or their blastic variant treated with high-dose methotrexate and cytarabine and high-dose cyclophosphamide, dexamethasone, doxorubicin, and vincristine (HCVAD). PROTOCOL OUTLINE: This is a multicenter study. Patients may receive either regimen A or both regimen A and regimen B, depending upon response. Regimen A: Patients receive methotrexate IV over 24 hours on day 1. Cytarabine is administered IV over 2 hours every 12 hours on days 2 and 3. Filgrastim (G-CSF) is administered subcutaneously (SC) daily beginning on day 4 and continuing until blood counts recover. Treatment repeats every 21 days for up to 8 courses. Regimen B: Patients receive cyclophosphamide IV over 3 hours every 12 hours on days 1-3. Doxorubicin is administered IV over 24 hours on days 4 and 5. Vincristine is administered IV over 30 minutes on days 4 and 11. Dexamethasone is administered orally or IV on days 1-4 and 11-14. G-CSF is administered SC beginning on day 6 and continuing until blood counts recover. Treatment repeats every 21 days for up to 7 courses. Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 21-45 patients will be accrued for this study within 4 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 16 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed previously untreated nodular or diffuse mantle cell lymphoma or their blastic variant - No CNS involvement - Not a candidate for stem cell transplantation or refuses one --Prior/Concurrent Therapy-- Biologic therapy: See Disease Characteristics Chemotherapy: Not specified Endrocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified --Patient Characteristics-- Age: 16 and over Performance status: Zubrod 0-2 Life expectancy: Not specified Hematopoietic: - Absolute neutrophil count greater than 1,000/mm3* - Platelet count greater than 100,000/mm3* [Note: * Unless lymphoma involvement] Hepatic: Bilirubin less than 1.5 mg/dL (unless lymphoma involvement) Renal: Creatinine less than 2.0 mg/dL (unless lymphoma involvement) Cardiovascular: Cardiac ejection fraction at least 50% (for patients over age 40) Other: - Must be willing to receive blood transfusion - Not pregnant or nursing - Fertile patients must use effective contraception - HIV negative - No other co-morbid medical or psychiatric illness that would preclude treatment - No prior or concurrent malignancy with poor prognosis
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JorgeRomaguera, Study Chair, M.D. Anderson Cancer Center
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Additional Information:
Study ID Numbers: CDR0000066258; MDA-DM-97200,NCI-T97-0101
Study Start Date: March 1999
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003311
Other Noncontiguous Stage 2 Mantle Cell Lymphoma Studies:
1. Combination Chemotherapy With or Without Rituximab in Treating Patients With Mantle Cell Lymphoma
2. Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Mantle Cell Lymphoma
3. Chemotherapy and Rituximab With Peripheral Stem Cell Transplantation in Treating Patients With Mantle Cell Lymphoma
4. Rituximab and Cladribine in Treating Patients With Newly Diagnosed Mantle Cell Lymphoma
5. Combination Chemotherapy Plus Rituximab and Radiation Therapy in Treating Patients With Stage I or Stage II Non-Hodgkin's Lymphoma
Related Studies:
Other noncontiguous stage 2 mantle cell lymphoma Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Combination Chemotherapy in Treating Patients With Newly Diagnosed Mantle Cell Lymphoma
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