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Lower-Dose Chemotherapy and Stem Cell Transplantation to Treat Childhood Leukemias and Lymphomas 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 Lower-Dose Chemotherapy and Stem Cell Transplantation to Treat Childhood Leukemias and Lymphomas conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Lower-Dose Chemotherapy and Stem Cell Transplantation to Treat Childhood Leukemias and Lymphomas Clinical research trials and Lower-Dose Chemotherapy and Stem Cell Transplantation to Treat Childhood Leukemias and Lymphomas 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 Lower-Dose Chemotherapy and Stem Cell Transplantation to Treat Childhood Leukemias and Lymphomas. Lower-Dose Chemotherapy and Stem Cell Transplantation to Treat Childhood Leukemias and Lymphomas 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 Lower-Dose Chemotherapy and Stem Cell Transplantation to Treat Childhood Leukemias and Lymphomas clinical trial. Subjects often receive the most expert healthcare possible for their Lower-Dose Chemotherapy and Stem Cell Transplantation to Treat Childhood Leukemias and Lymphomas 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 > "L" Clinical Trials Conditions > Lower-Dose Chemotherapy and Stem Cell Transplantation to Treat Childhood Leukemias and Lymphomas  Lower-Dose Chemotherapy and Stem Cell Transplantation to Treat Childhood Leukemias and Lymphomas
Lower-Dose Chemotherapy and Stem Cell Transplantation to Treat Childhood Leukemias and Lymphomas
For Condition: Non Hodgkin's Lymphoma,Myelodysplastic Syndrome,Lymphocytic Leukemia,Mixed Cell Leukemia,Hodgkin Lymphoma
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This study will investigate the safety and effectiveness of a new stem cell transplant procedure for treating various leukemias and lymphomas in children. Transplantation of donated stem cells (cells produced by the bone marrow that mature into white and red blood cells and platelets) is a very effective treatment for patients with leukemia, pre-leukemia and lymphoma. However, despite its success in a large number of patients, this procedure has many serious side effects and carries a significant risk of death. These complications result from the intensive chemotherapy and radiation patients receive before the transplant to rid the body of cancer cells. In this study, radiation will not be used and chemotherapy drugs will be given in lower doses to try to reduce the dangers of the procedure. Patients between 5 and 21 years of age with acute lymphocytic leukemia, acute myelogenous leukemia, myelodysplasia, chronic myelogenous leukemia, juvenile chronic myelogenous or myelomonocytic leukemia, Hodgkin's disease and non-Hodgkin's lymphoma may be eligible for this study. Candidates will be screened with a medical history, physical examination, blood tests (including testing for genetic match with the donor), breathing tests, X-rays, scans and other tests to determine eligibility. They may also undergo bone marrow aspiration, in which the hip area is anesthetized and a small sample of bone marrow is drawn through a needle inserted into the hipbone. A spinal tap may be done to look for cancer cells in the central nervous system. This procedure involves numbing the back and inserting a needle between the bones of the spine to withdraw a small amount of spinal fluid. A central venous catheter (flexible plastic tube placed in a vein) will be put in place before treatment begins. It will be used to draw and transfuse blood, give medications, and infuse the donated stem cells. Before the transplant procedure, patients will receive induction chemotherapy with cyclophosphamide, fludarabine, etoposide, doxorubicin, vincristine and prednisone for 4 days, followed by a 17-day rest period. No more than 3 cycles of this chemotherapy will be given. Following the induction chemotherapy, patients will be admitted to the Clinical Center for 4 days of chemotherapy with cyclophosphamide and fludarabine. The donated stem cells will be infused 3 days later. Patients can leave the hospital when their white cell counts return to near normal and they have no serious complications. After discharge, they will be followed closely (at least once or twice weekly for the first 100 days after transplant) with a physical exam and blood tests. Patients may require immunoglobulin or antibiotics to fight infections and transfusions of red blood cells and platelets. After the 100 days, follow-up visits will continue less frequently for at least 5 years.
Details: Allogeneic blood and marrow stem cell transplantation (BMT) plays an important role in the curative treatment of a number of pediatric malignancies. Unfortunately, the success of conventional allogeneic BMT is limited in part by the multiple toxicities associated with myeloablative preparative regimens. The primary aim of this protocol is to evaluate the efficacy and safety of a novel non-myeloablative chemotherapy regimen in facilitating donor engraftment after allogeneic BMT in pediatric patients with hematopoietic malignancies. The goal is to develop an effective BMT platform that will be less toxic than conventional myeloablative preparative regimens. Such myeloablative regimens, which typically utilize total body irradiation (TBI) and high-dose chemotherapy, were once considered essential for both the eradication of residual malignant disease and the prevention of graft rejection. However, recent clinical studies challenge both of these precepts. An allogeneic immunologic reaction has been demonstrated to play a role in the eradication of residual malignant disease (the so-called graft-versus-leukemia, GVL, or graft-versus-tumor, GVT, effect). It has also been well demonstrated that non-myeloablative doses of chemotherapy can facilitate alloengraftment. In murine models, we have demonstrated that severe host T-cell depletion induced by combination fludarabine and cyclophosphamide can prevent even fully-MHC mismatched marrow graft rejection. We have designed a pilot study of allogeneic BMT using an immunoablative, non-myeloablative chemotherapy regimen for pediatric patients with hematopoietic malignancies. Participants must have related HLA-matched allogeneic donors. Novel induction and transplant preparative regimens designed to maximally deplete host immune T-cells capable of mediating graft rejection will be administered. After induction and preparative regimen chemotherapy, patients will receive an unmanipulated, G-CSF mobilized peripheral blood stem cell graft. This transplant regimen has recently been successfully piloted in the Medicine Branch at the NCI (NIH#99-C-0143). Seventeen of the initial eighteen adult subjects who received this treatment demonstrated complete donor engraftment (greater than 95% donor lymphoid chimerism by day 28 post-transplant).
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA PATIENTS: Patients with the following diagnoses will be considered: -Hodgkin's and Non-Hodgkin's Lymphoma: Refractory (non-CR) to primary treatment regimen; Refractory (non-CR) to or relapse after salvage regimen. -Acute Myelogenous Leukemia (AML): History of bone marrow relapse it CR number 2 or greater. -Acute Lymphocytic Leukemia (ALL): History of bone marrow relapse in CR number 2 or greater; complete remission #1 with Philadelphia chromosome positive or prior induction failure (subsequent induction regimen required to achieve CR). -Acute hybrid leukemia including mixed lineage, biphenotypic, and undifferentiated (AUL): History of bone marrow relapse in CR number 2 or greater; Complete remission #1 with Philadelphia chromosome positive or prior induction failure (second induction regimen required to achieve (CR). -Myelodysplastic Syndrome (MDS) excluding refractory anemia (RA) and RA with ringed sideroblasts (RARS): blasts less than 10% in marrow and blood. -Chronic Myelogenous Leukemia (CML): Chronic Phase; Accelerated Phase with blasts less than 10% in marrow and blood. -Juvenile Myelomonocytic Leukemia (JMML, J-CML) : Blasts less than 10% in marrow and blood. Patients must be greater than or equal to 4 years and less than 22 years of age. Prior chemotherapy: Chemotherapy to achieve above noted criteria allowed. Prior autologous BMT allowed. Prior allogeneic BMT allowed as long as at least day +100 post-prior BMT, and no evidence of ongoing active GVHD. Availability of 5 or 6 antigen genotypic HLA-matched first-degree relative donor (single HLA-A or B locus mismatch allowed). Performance status of 0,1,or 2. Life expectancy greater than 3 months. Liver function: serum direct bilirubin less than 2.0 mg/dL, and serum ALT and AST values less than or equal to 2.5 times the upper limit of normal. Values above these levels may be accepted, at the discretion of the PI, if such elevations are thought to be due to malignancy (excluding acute leukemia). Renal function: age-adjusted normal serum creatinine or a creatinine clearance greater than or equal to 60 mL/min/1.73 m(2). Pulmonary function: DLCO corrected for hemoglobin and alveolar volume greater than or equal to 50% of predicted. Left ventricular function: Ejection fraction greater than or equal to 45% by MUGA or shortening fraction greater than or equal to 28% by ECHO. Ability to give informed consent. For patients less than 18 years old their legal guardian must give informed consent. Pediatric patients will be included in age appropriate discussion in order to obtain verbal assent. Durable power of attorney form completed (patients greater than 18 years of age only). Patients must not have an active CNS malignancy as defined by: lymphoma (tumor mass on CT scan or leptomeningeal disease), Leukemia (CNS 2 or CNS 3 classification), or NB (History of CNS involvement with no current evidence of CNS malignancy is NOT an exclusion). Patients must not be HIV positive. Patients must not have active hepatitis B or C infection as defined by seropositive for hepatitis B (HbSAg) or hepatitis C and elevated liver transaminases. Female patients must not be lactating or pregnant (due to risk to fetus or newborn). Patients must not have high risk of inability to comply with transplant protocol as determined by principal investigator, social work, and BMT team. Patients must not have Fanconi Anemia (FA): patients with MDS must have a negative FA test. INCLUSION CRITERIA DONOR: First degree relative with genotypic identity at 5 or 6 HLA loci (single HLA-A or B locus mismatch allowed). Weight of greater than or equal to 15 kilograms. Adequate venous access for peripheral apheresis, or consent to use a temporary central venous catheter for apheresis. Ability to give informed consent. For donors less than 18 years of age, he/she must be the oldest eligible donor, their legal guardian must give informed consent, the donor must give verbal assent, and he/she must be cleared by social work and a mental health specialist to participate. Donor selection criteria will be in accordance with NIH/CC Department of Transfusion Medicine standards. EXLCUSION CRITERIA PATIENT: Active CNS malignancy as defined by: -Lymphoma: tumor mass on CT scan or leptomeningeal disease -Leukemia: CNS 2 or CNS 3 classification -NB: History of CNS involvement with no current evidence of CNS malignancy is NOT an exclusion. HIV positive. Active hepatitis B or C infection as defined by seropositive for hepatitis B (HbsAg) or hepatitis C and elevated liver transaminases. Lactating or pregnant females. High risk of inability to comply with transplant protocol as determined by principal investigator, social work, and BMT team. Fanconi Anemia (FA): Patients with MDS must have a negative FA test. EXCLUSION CRITERIA DONOR: History of medical illness which in the estimation of the PI or DTM physician poses prohibitive risk to donation including, but not limited to stroke, hypertension that is not controlled by medication, or heart disease. Individuals with symptomatic angina or a history of coronary artery bypass grafting or angioplasy will not be eligible. History of congenital hematologic, immunologic, or metabolic disorder which in the estimation of the PI poses prohibitive risk to the receipient. Anemia (Hb less than gm/dl) or thrombocytopenia (less than 100,000/ul). Lactating or pregnant females. HIV positive. Seropositive for hepatitis B (HbsAg) or hepatitis C. High risk of inability to comply with transplant protocol as determined by principal investigator, social work, and BMT team.
Total Enrollment: 36
Location and Contact Information:
National Cancer Institute (NCI) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Clinical Support Center/NCI 1-888-624-1937
Additional Information:
Study ID Numbers: 010125; 01-C-0125
Study Start Date: March 14, 2001
Record last reviewed: March 1, 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00013533
Other Myelodysplastic Syndrome Studies:
1. Lower-Dose Chemotherapy and Stem Cell Transplantation to Treat Childhood Leukemias and Lymphomas
Related Studies:
Other Myelodysplastic Syndrome Clinical Trials
Other Maryland Clinical Trials
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Lower-Dose Chemotherapy and Stem Cell Transplantation to Treat Childhood Leukemias and Lymphomas
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