|
Bone Marrow Transplantation Plus Cyclophosphamide and Radiation Therapy in Treating Patients With Hematologic Cancer Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Bone Marrow Transplantation Plus Cyclophosphamide and Radiation Therapy in Treating Patients With Hematologic Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Bone Marrow Transplantation Plus Cyclophosphamide and Radiation Therapy in Treating Patients With Hematologic Cancer Clinical research trials and Bone Marrow Transplantation Plus Cyclophosphamide and Radiation Therapy in Treating Patients With Hematologic Cancer healthcare trials happen in many 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 drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Bone Marrow Transplantation Plus Cyclophosphamide and Radiation Therapy in Treating Patients With Hematologic Cancer. Bone Marrow Transplantation Plus Cyclophosphamide and Radiation Therapy in Treating Patients With Hematologic Cancer Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Bone Marrow Transplantation Plus Cyclophosphamide and Radiation Therapy in Treating Patients With Hematologic Cancer clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Bone Marrow Transplantation Plus Cyclophosphamide and Radiation Therapy in Treating Patients With Hematologic Cancer condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "B" Clinical Trials Conditions > Bone Marrow Transplantation Plus Cyclophosphamide and Radiation Therapy in Treating Patients With Hematologic Cancer  Bone Marrow Transplantation Plus Cyclophosphamide and Radiation Therapy in Treating Patients With Hematologic Cancer
Bone Marrow Transplantation Plus Cyclophosphamide and Radiation Therapy in Treating Patients With Hematologic Cancer
For Condition: Chronic Lymphocytic Leukemia,atypical chronic myeloid leukemia,Chronic Myelogenous Leukemia,Acute Lymphocytic Leukemia,Acute Myeloid Leukemia,myelodysplastic and myeloproliferative disease
Status: Recruiting
Sponsor(s): Fox Chase 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 bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Radiation therapy uses high-energy x-rays to damage cancer cells. PURPOSE: Phase II trial to study the effectiveness of bone marrow transplantation from an unrelated donor plus cyclophosphamide and radiation therapy in treating patients who have hematologic cancer.
Details: OBJECTIVES: - Study the curative potential of high dose cyclophosphamide and total body irradiation followed by rescue with bone marrow from volunteer HLA matched donors in patients with a variety of hematologic malignancies and bone marrow failure states. - Study the toxic effects associated with matched unrelated bone marrow transplantation in this patient population. - Participate in collaborative research studies with the National Marrow Donor Program. OUTLINE: All patients receive myeloablative therapy with high dose cyclophosphamide and total-body irradiation over 4 days; patients with severe aplastic anemia also receive antithymocyte globulin. Patients then undergo allogeneic bone marrow transplantation. Filgrastim (G-CSF) is given following transplant to accelerate engraftment. Sargramostim (GM-CSF) may be given in case of graft failure. All patients receive graft-versus-host-disease (GVHD) prophylaxis with tacrolimus, methotrexate, and gamma-globulin. Established GVHD is treated with corticosteroids and, as necessary, antithymocyte globulin. Patients are followed at 100 days, 6 months, and 1 year following transplant, then annually thereafter. PROJECTED ACCRUAL: A total of 10 patients per year will be accrued for this study over 5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 15 Years/50 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - One of the following hematologic malignancies/disorders: - Acute lymphoblastic leukemia - In second or subsequent complete remission (CR) - In first CR with high-risk features (e.g., Philadelphia chromosome-positive) - In first relapse and failed conventional salvage therapy - Acute myelogenous leukemia (AML) - In second or subsequent CR - In early first relapse - In full first relapse and failed conventional salvage therapy - In first CR with high-risk features, e.g., trisomy 8 or FAB 6/7 - Standard-risk AML offered conventional dose consolidation chemotherapy or autologous bone marrow transplantation - Chronic myelogenous leukemia in chronic, accelerated, or second chronic phase - No blast crisis - Severe aplastic anemia that has failed at least 1 course of immunosuppressive therapy - Paroxysmal nocturnal hemoglobinuria with high-risk features (e.g., DIC, thrombotic events) - Myelodysplastic syndrome, i.e.: - Symptomatic, transfusion-dependent refractory anemia with excess blasts - (RAEB) or RAEB in transformation - Secondary leukemia in CR following conventional-dose induction chemotherapy - Unrelated marrow donor available who is 6-antigen serologically HLA-matched at A, B, DR loci, and (DRBeta1) match by molecular typing - No HLA-identical (6/6 or 5/6) matched sibling or extended family member donor available - Patients less than 40 years old allowed a class I mismatch at one A or B loci (by serology distinct at A or B, but crossreactive antigen as defined by NMDP) - Negative recipient anti-donor crossmatch required - No CNS malignancy PATIENT CHARACTERISTICS: Age: - 15-50 Performance status: - Karnofsky 70-100% Life expectancy: - No reduction due to other serious illness Hematopoietic: - Not specified Hepatic: - Bilirubin less than 3 mg/dL - AST/ALT no greater than twice normal Renal: - Creatinine no greater than 2.0 mg/dL - Creatinine clearance greater than 60 mL/min Cardiovascular: - Left ventricular ejection fraction at least 45% - No severe hypertension Pulmonary: - DLCO, FEV_1, and FVC at least 50% Other: - HIV negative - No active infection at time of transplant - No advanced diabetes - No significant neurologic deficit - No active drug or substance abuse - No emotional disorders - Able to participate in frequent medical care for at least 1-2 years - Willing to comply with National Marrow Donor Program policies PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics Chemotherapy - See Disease Characteristics Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
KennethMangan, Study Chair, Fox Chase Cancer Center
Fox Chase - Temple Cancer Center *Recruiting*
Philadelphia, Pennsylvania, 19111-2442
United States
Recruiting Kenneth Mangan 215-214-3129
Additional Information:
Study ID Numbers: CDR0000064937; TUHSC-2803,NCI-V96-0950
Study Start Date:
Record last reviewed: August 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002809
Other Atypical Chronic Myeloid Leukemia Studies:
1. Thalidomide in Treating Anemia in Patients With Myelodysplastic Syndrome
2. Busulfan and Cyclophosphamide Followed by Bone Marrow Transplantation in Treating Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome
3. Radiolabeled Monoclonal Antibody Therapy and Etoposide Followed by Peripheral Stem Cell Transplantation in Treating Patients With Advanced Myelodysplastic Syndrome or Refractory Leukemia
4. 3-AP Followed By Fludarabine In Treating Patients With Relapsed or Refractory Acute or Chronic Leukemia or High-Risk Myelodysplastic Syndrome
5. Bone Marrow Transplantation Plus Cyclophosphamide and Radiation Therapy in Treating Patients With Hematologic Cancer
Related Studies:
Other atypical chronic myeloid leukemia Clinical Trials
Other Pennsylvania Clinical Trials
Other Philadelphia Clinical Trials
Bone Marrow Transplantation Plus Cyclophosphamide and Radiation Therapy in Treating Patients With Hematologic Cancer
|
|
|
|
|
|
|
|
