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Chemotherapy Plus Bone Marrow Transplantation in Treating Patients With Refractory Non-Hodgkin's Lymphoma, Hodgkin's Disease, or Multiple Myeloma Clinical Trials Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD on Chemotherapy Plus Bone Marrow Transplantation in Treating Patients With Refractory Non-Hodgkin's Lymphoma, Hodgkin's Disease, or Multiple Myeloma conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Chemotherapy Plus Bone Marrow Transplantation in Treating Patients With Refractory Non-Hodgkin's Lymphoma, Hodgkin's Disease, or Multiple Myeloma Clinical research trials and Chemotherapy Plus Bone Marrow Transplantation in Treating Patients With Refractory Non-Hodgkin's Lymphoma, Hodgkin's Disease, or Multiple Myeloma health trials take place in a lot of of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like Chemotherapy Plus Bone Marrow Transplantation in Treating Patients With Refractory Non-Hodgkin's Lymphoma, Hodgkin's Disease, or Multiple Myeloma. Chemotherapy Plus Bone Marrow Transplantation in Treating Patients With Refractory Non-Hodgkin's Lymphoma, Hodgkin's Disease, or Multiple Myeloma Clinical Trials and other clinical trials allow for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Chemotherapy Plus Bone Marrow Transplantation in Treating Patients With Refractory Non-Hodgkin's Lymphoma, Hodgkin's Disease, or Multiple Myeloma clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their Chemotherapy Plus Bone Marrow Transplantation in Treating Patients With Refractory Non-Hodgkin's Lymphoma, Hodgkin's Disease, or Multiple Myeloma condition. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Chemotherapy Plus Bone Marrow Transplantation in Treating Patients With Refractory Non-Hodgkin's Lymphoma, Hodgkin's Disease, or Multiple Myeloma  Chemotherapy Plus Bone Marrow Transplantation in Treating Patients With Refractory Non-Hodgkin's Lymphoma, Hodgkin's Disease, or Multiple Myeloma
Chemotherapy Plus Bone Marrow Transplantation in Treating Patients With Refractory Non-Hodgkin's Lymphoma, Hodgkin's Disease, or Multiple Myeloma
For Condition: recurrent diffuse small lymphocytic/marginal zone lymphoma,recurrent adult diffuse small cleaved cell lymphoma,recurrent adult lymphoblastic lymphoma,recurrent grade III follicular large cell lymphoma,recurrent adult immunoblastic large cell lymphoma,recurrent adult diffuse small noncleaved cell/Burkitt's lymphoma,recurrent adult Hodgkin's disease,recurrent adult diffuse mixed cell lymphoma,recurrent mantle cell lymphoma,recurrent grade I follicular small cleaved cell lymphoma,recurrent small lymphocytic lymphoma,recurrent grade II follicular mixed cell lymphoma,recurrent adult diffuse large cell lymphoma,refractory plasma cell neoplasm
Status: No longer recruiting
Sponsor(s): Barbara Ann Karmanos Cancer Institute ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining bone marrow transplantation with chemotherapy may allow doctors to give higher doses of chemotherapy and kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of bone marrow transplantation plus chemotherapy in treating patients who have refractory non-Hodgkin's lymphoma, Hodgkin's lymphoma, or multiple myeloma.
Details: OBJECTIVES: I. Assess the toxicities, response rate, and duration of response associated with high-dose cyclophosphamide, etoposide, carmustine or high-dose cyclophosphamide and total-body irradiation followed by autologous, allogeneic, or syngeneic bone marrow transplant in patients with refractory or high-risk non-Hodgkin's lymphoma, Hodgkin's disease, or multiple myeloma. II. Evaluate any prognostic factors. PROTOCOL OUTLINE: Patients with prior radiotherapy (greater than 2,000 cGy) receive cyclophosphamide IV over 2 hours and etoposide IV over at least 30 minutes on days -7 through -4 followed by carmustine IV over 2 hours on day -3. Patients receive allogeneic or autologous bone marrow transplantation on day 0. Patients with or without prior radiotherapy (less than 2,000 cGy) receive cyclophosphamide IV over 2 hours on days -8 through -5 followed by total body irradiation on days -4 through -1. Patients receive allogeneic or autologous bone marrow transplantation on day 0. Prior to autologous bone marrow transplantation and following myeloablative chemotherapy, patients undergo mobilization consisting of cytarabine subcutaneously every 12 hours for 6 doses. Approximately 24 hours later, patients receive sargramostim (GM-CSF) subcutaneously. Peripheral blood stem cells are collected every 1-3 days beginning when blood counts recover and continuing until sufficient number of cells are reached. PROJECTED ACCRUAL: Approximately 40 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /70 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven Hodgkin's disease (HD), non-Hodgkin's lymphoma (NHL), and multiple myeloma (MM) meeting the following requirements: Refractory to or at high risk following prior therapy; Responded with at least a partial response to last cytoreductive regimen; No bulky disease (individual tumor diameter larger than 5 cm) - Eligible HD: CNS involvement at original presentation and currently in complete response (CR); Relapsed within 1 year following completion of front-line MOPP or ABVD; Relapsed at any time following front-line MOPP/ABVD or other hybrid - Eligible NHL: Any grade lymphoma with CNS involvement at original presentation and currently in CR; High-grade lymphomas (International Working Formulation H-J) with marrow involvement at original presentation and currently in CR, EXCEPT: Immunoblastic lymphoma and large cell (IWF G and H) with bone marrow involvement with small cleaved cell at original presentation; High-/intermediate-grade lymphomas (IWF D-J) in relapse after adequate front-line therapy; High-/intermediate-grade lymphomas (IWF D-J) that failed to achieve CR with adequate front-line therapy; Low-grade lymphomas (IWF A-C) with B symptoms at original presentation and relapse after front-line therapy; Low-grade lymphomas (IWF A-C) in relapse within 1 year following last chemotherapy; Low-grade lymphomas (IWF A-C) with documented histologic conversion - Eligible MM: Diagnosis based on either presence of both Group I diagnostic criteria OR One Group I criterion and all Group II criteria; Group I diagnostic criteria: Plasma cells and/or myeloma cells greater than 10% in bone marrow; Biopsy-proven plasmacytoma in bone or soft tissue - Group II diagnostic criteria: Monoclonal serum protein spike; Urinary myeloma protein; Osteolytic lesions on radiologic examination; Generalized osteoporosis suffices if plasma cells in marrow exceed 30%; Myeloma cells in at least 2 peripheral blood smears - Stage II/III disease documented sometime during clinical course; Stage III defined by presence of at least 1 of the following: Hemoglobin less than 8.5 g/dl; Serum calcium greater than 12 mg/dl; Advanced lytic bone lesions; High M-component production rates: IgG greater than 7 g/dl IgA greater than 5 g/dl; Urinary light chain greater than 4 g/24 hours - Stage II disease defined by absence of Stage III characteristics but presence of at least 1 of the following: Hb less than 10 g/dl; More than 1 osteolytic lesion, none advanced; IgG greater than 5 g/dl; IgA greater than 3 g/dl - Bone marrow donor available for lymphoma patients with marrow involvement; Perfosfamide-purged autologous transplant allowed in patients with no matched sibling donor if: Marrow involvement is limited (less than 30% tumor cells on smears and in bilateral iliac crest biopsies) AND Age is under 60 - Donor requirements: Excellent physical condition by history, lab studies, PE; No physiologic, psychologic, or medical inability to tolerate the procedure; No increased anesthetic risk; No HIV infection - Priority of multiple donors (in order given): ABO compatible; Age over 18; Same sex as recipient [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 --Patient Characteristics-- - Age: 70 and under - Performance status: 0-2 - Life expectancy: No severe limitation due to nonmalignant disease - Hematopoietic: Not specified - Hepatic: No severe hepatic disease; Bilirubin no greater than 2.0 mg/dL; Transaminases no greater than 3 times normal - Renal: No severe renal disease; Creatinine no greater than 1.5 mg/dL; Creatinine clearance at least 60 mL/min - Cardiovascular: No symptomatic cardiac disease; LVEF at least 50% - Pulmonary: No severe pulmonary disease; FEV1 and FVC at least 75% of normal - Other: No history of severe cystitis with cyclophosphamide; No HIV infection; No severe personality disorder or severe mental illness; No other condition that would markedly increase the morbidity and mortality of transplantation (e.g., substance abuse) - Patients with borderline parameters of organ function, performance status, or mental status are entered at the discretion of the transplant team
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RodgerDansey, Study Chair, Barbara Ann Karmanos Cancer Institute
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
United States
Additional Information:
Study ID Numbers: CDR0000063370; WSU-D-701-87,NCI-V94-0364
Study Start Date: October 1993
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002552
Other Recurrent Adult Diffuse Small Cleaved Cell Lymphoma Studies:
1. Cyclophosphamide and Filgrastim in Treating Patients With Stage IV, Relapsed, or Refractory Low-Grade Follicular Non-Hodgkin's Lymphoma
2. Interferon Alfa Plus Thalidomide in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
3. Combination Chemotherapy and Radiation Therapy Plus Bone Marrow Transplantation in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
4. Radiolabeled Monoclonal Antibody Therapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Lymphoma or Waldenstrom's Macroglobulinemia
5. Monoclonal Antibody Therapy in Treating Patients With Recurrent Non-Hodgkin's Lymphoma
Related Studies:
Other recurrent adult diffuse small cleaved cell lymphoma Clinical Trials
Other Michigan Clinical Trials
Other Detroit Clinical Trials
Chemotherapy Plus Bone Marrow Transplantation in Treating Patients With Refractory Non-Hodgkin's Lymphoma, Hodgkin's Disease, or Multiple Myeloma
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