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Combination Chemotherapy in Treating Patients With Lymphoma Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Combination Chemotherapy in Treating Patients With Lymphoma conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Combination Chemotherapy in Treating Patients With Lymphoma Clinical research trials and Combination Chemotherapy in Treating Patients With Lymphoma medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Combination Chemotherapy in Treating Patients With Lymphoma. Combination Chemotherapy in Treating Patients With Lymphoma Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Combination Chemotherapy in Treating Patients With Lymphoma clinical trial. Subjects often receive the most expert healthcare possible for their Combination Chemotherapy in Treating Patients With Lymphoma condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy in Treating Patients With Lymphoma  Combination Chemotherapy in Treating Patients With Lymphoma
Combination Chemotherapy in Treating Patients With Lymphoma
For Condition: 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 chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of combination chemotherapy in treating patients who have intermediate-grade or immunoblastic lymphoma.
Details: OBJECTIVES: I. Compare the efficacy of early intensification vs alternating triple chemotherapy in patients with intermediate-grade or immunoblastic lymphoma with poor prognostic features. II. Compare, in a prospective manner, the cost/benefit ratio of these regimens in these patients. III. Determine the value of monitoring minimal residual disease detection via in vitro culture methods and polymerase chain reaction analysis of peripheral stem cell apheresis products and by longitudinal monitoring of blood and bone marrow samples in these patients treated with these regimens. PROTOCOL OUTLINE: This is a randomized study. Patients are stratified according to tumor score (3 or 4 vs 5 or 6). During the first course of induction, patients receive IDSHAP comprising idarubicin (IDA) and cisplatin IV continuously on days 1-4, cytarabine (ARA-C) IV over 2 hours on day 5, and methylprednisolone (MePRDL) IV over 15 minutes on days 1-5. During the second course of induction, patients receive MBIDCOS comprising vincristine, bleomycin, and cyclophosphamide IV over 15 minutes on day 1, IDA IV continuously and MePRDL IV over 15 minutes on days 1-3, methotrexate (MTX) IV over 2 hours on day 10, and oral leucovorin calcium every 6 hours on days 11 and 12. Each course lasts 3 weeks in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease after induction are randomized to 1 of 2 treatment arms. Arm I: Patients receive the following 3 courses of early intensification. First course: Patients receive ifosfamide (IFF) IV continuously and etoposide (VP-16) IV over 2 hours every 12 hours on days 1-3. Filgrastim (G-CSF) is administered subcutaneously (SC) beginning on day 5 and continuing until blood counts recover and then autologous peripheral blood stem cells (PBSC) are harvested, selected for CD34 positive cells, and purged in vitro. If more than 5% of the WBC contains lymphoma cells after induction, then 2 courses of IFF and VP-16 are administered before PBSC harvest. Second course: Patients receive IFF IV continuously on days 1-3, mitoxantrone (DHAD) IV on day 1, and G-CSF SC as in the first course. Third course: Patients receive carmustine IV over 1 hour on day -6, ARA-C and VP-16 IV every 12 hours on days -5 to -2, and melphalan IV on day -1. PBSC are reinfused on day 0. G-CSF is administered SC beginning on day 0 and continuing until blood counts recover. Each course lasts 3 weeks in the absence of disease progression or unacceptable toxicity. Arm II: Patients receive IDSHAP during courses 2 and 5, MBIDCOS during courses 3 and 6, and IFF and VP-16 IV over 1 hour on days 1-3 and DHAD IV over 15 minutes on day 1 during courses 1, 4, and 7. Each course lasts 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with residual disease after completion of arm I or II treatment undergo radiotherapy to areas of bulk disease if feasible. Patients on both arms with meningeal involvement receive ARA-C intrathecally (IT) alternated with MTX every other day until 1 week after clearing of CNS disease and then 2 IT injections during every course of chemotherapy thereafter. Patients with divergent histology who achieve complete response after completion of arm I or II treatment receive interferon alfa 3 times a week for 1 year. Patients are followed at 1 month, every 3 months for 1 year, every 6 months for 1 year, and then annually for 2 years. PROJECTED ACCRUAL: A maximum of 136 patients will be accrued for this study within 4 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 15 Years/59 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Diagnosis of previously untreated intermediate-grade or immunoblastic lymphoma - Tumor score of 3 or greater, defined by the presence of 3 or more of the following criteria: *Ann Arbor stage III or IV disease *B symptoms (fever, sweats, and weight loss greater than 10%) *At least 1 tumor mass greater than 7 cm or mediastinal mass visible on plain chest x-ray *Beta-2 microglobulin at least 3.0 *Lactic dehydrogenase at least 1.1 times the upper limit of normal - T- and B-cell lymphomas allowed if intermediate grade or immunoblastic - Divergent histologies, including bone marrow involvement, allowed - CNS involvement allowed Note: 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-- No prior therapy --Patient Characteristics-- Age: 15 to 59 Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin less than 2.0 mg/dL (unless elevation due to lymphoma) Renal: Creatinine no greater than 1.5 mg/dL (unless elevation due to lymphoma) Cardiovascular: - LVEF greater than 50% by echocardiogram if over age 45 - No congestive heart failure, angina, history of myocardial infarction, or arrhythmia unless cleared by principal investigator after cardiology consultation Pulmonary: - No history of chronic obstructive or restrictive lung disease - Pulmonary consultation required for smokers or patients with questionable lung function Other: - HIV negative - Not pregnant or nursing - Fertile patients must use effective contraception - No prior malignancy with poor prognosis (less than 90% probability of surviving for 5 years) - No geographic, economic, emotional, or social condition that would preclude study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RichardChamplin, 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: CDR0000065044; MDA-DM-95121,NCI-V96-1010
Study Start Date: July 1995
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002835
Other Lymphoma Studies:
1. Interleukin-11 Plus Filgrastim Prior to Peripheral Stem Cell Transplantation in Patients With Non-Hodgkin's Lymphoma, Hodgkin's Disease, Breast Cancer, or Other Solid Tumors
2. Total-Body Irradiation With Or Without Fludarabine Followed By Allogeneic Hematopoietic Stem Cell Transplantation in Treating Patients With Hematologic Malignancies
3. Yttrium Y 90 SMT 487 in Treating Patients With Refractory or Recurrent Cancer
4. Combination Chemotherapy in Treating Patients With Recurrent or Refractory Leukemia or Lymphoma
5. Interleukin-2 Immunotoxin Therapy in Treating Patients With Indolent Stage II, Stage III, or Stage IV Non-Hodgkin's Lymphoma
Related Studies:
Other Lymphoma Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Combination Chemotherapy in Treating Patients With Lymphoma
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