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Chemotherapy Plus Radiation Therapy and Biological Therapy in Treating Patients With Hematologic Cancer Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Chemotherapy Plus Radiation Therapy and Biological Therapy in Treating Patients With Hematologic Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Chemotherapy Plus Radiation Therapy and Biological Therapy in Treating Patients With Hematologic Cancer Clinical research trials and Chemotherapy Plus Radiation Therapy and Biological Therapy in Treating Patients With Hematologic Cancer health trials happen in many 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 effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Chemotherapy Plus Radiation Therapy and Biological Therapy in Treating Patients With Hematologic Cancer. Chemotherapy Plus Radiation Therapy and Biological Therapy in Treating Patients With Hematologic Cancer Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Chemotherapy Plus Radiation Therapy and Biological Therapy in Treating Patients With Hematologic Cancer clinical trial. Subjects frequently get the best healthcare possible for their Chemotherapy Plus Radiation Therapy and Biological Therapy in Treating Patients With Hematologic Cancer condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Chemotherapy Plus Radiation Therapy and Biological Therapy in Treating Patients With Hematologic Cancer  Chemotherapy Plus Radiation Therapy and Biological Therapy in Treating Patients With Hematologic Cancer
Chemotherapy Plus Radiation Therapy and Biological Therapy in Treating Patients With Hematologic Cancer
For Condition: Lymphoma,Leukemia
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , Fred Hutchinson Cancer Research Center
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill tumor cells. PURPOSE: Phase II trial to study the effectiveness of bone marrow transplantation using unrelated bone marrow donors in treating patients who have hematologic cancer.
Details: OBJECTIVES: I. Determine whether the use of donors with a one non crossreactive group (CREG) mismatch for HLA-A or B in patients less than 36 years of age is associated with more frequent graft versus host disease (GVHD) of grades III-IV than previously observed with donors with one CREG mismatch. II. Determine whether the use of donors with a one CREG mismatch for HLA-A or B in patients 36-50 years of age is associated with more frequent GVHD of grades III-IV than previously observed with matched donors. III. Determine the relevance of HLA-A allele mismatching in bone marrow transplants from donors matched for HLA-A, B, and DR phenotypes. PROTOCOL OUTLINE: This is a parallel, open label study. Patients are assigned to 1 of 3 treatment arms. Arm I: Patients receive cyclophosphamide IV on days -7 and -6 and total body irradiation (TBI) 3 times a day on days -4 through -1. Allogeneic bone marrow (ABM) is infused on day 0. Arm II: Patients receive therapy as in arm I, except TBI is administered twice a day on day -1 only. ABM is infused on day 0. Arm III: Patients receive cyclophosphamide IV on days -6 and -5 and TBI twice a day on days -3 through -1. ABM is infused on day 0. Males with ALL receive an additional radiation boost to the testes during TBI. Patients are followed at least every 6 months for 2 years, then annually thereafter. PROJECTED ACCRUAL: A total of 50 patients under 36 years old and 50 patients 36-50 years old will be accrued for this study within 5 years. Additional patients will be accrued for the standard therapy arm of this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /55 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Hematologic malignancies of the following types: Chronic myelogenous leukemia (CML) in chronic or accelerated phase; Newly diagnosed acute leukemia at high risk of relapse following chemotherapy alone; Early referral encouraged so that donor search can begin as soon as possible; Acute leukemia failing one cycle of induction chemotherapy; Acute leukemia beyond first remission - High-risk Hodgkin's disease and non-Hodgkin's lymphoma in first remission; Hodgkin's disease, non-Hodgkin's lymphoma, or other malignant lymphoproliferative disease after first remission - No suitable related donor available (i.e., no HLA genotypically identical sibling); No haploidentical relative with no more than 1 unshared haplotype for an HLA-A, -B, or -D locus - Acute leukemia in relapse and CML in blast crisis eligible only under the following conditions: Patient's clinical condition is likely to remain stable for the 2-6 month period necessary to find a marrow donor; Remission induction has been attempted; Local physician and patient accept that the search or transplant may be canceled if the patient's condition deteriorates during the search - No leukoencephalopathy - Donor requirements: Age less than 60 In good health; Phenotypically identical for HLA-A, -B, and -DRB1 1-antigen mismatch for HLA-A, -B, or -DRB1 locus allowed for patients below age 36 - Patients for whom TBI is contraindicated may be treated on protocol FHCRC-739 - Severe aplastic anemia should be transplanted according to protocols FHCRC-174.2 or FHCRC-800 - Myelodysplastic syndrome should be transplanted according to protocol FHCRC-179.3 or FHCRC-844 --Prior/Concurrent Therapy-- - No more than 3,000 cGy to the whole brain; No more than 1,500 cGy to the chest or abdomen; At least 6 months since involved-field irradiation to the chest or abdomen --Patient Characteristics-- - Age: Under 56 - Performance status: Not specified - Life expectancy: Not specified - Hematopoietic: Not specified - Hepatic: No acute hepatitis; No other severe hepatic disease - Renal: Creatinine less than 2 times normal for age, weight, and sex - Cardiovascular: No symptomatic cardiac disease - Pulmonary: No active pulmonary disease; No history of pulmonary fibrosis; No severe hypoxemia (pO2 less than 70 mm Hg and DLCO less than 70%); No mild hypoxemia (pO2 less than 80 mm Hg and DLCO less than 60%) - Other: HIV negative; No severe limitations due to diseases other than malignancy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ClaudioAnasetti, Study Chair, Fred Hutchinson Cancer Research Center
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
United States
Additional Information:
Study ID Numbers: CDR0000063397; FHCRC-160.06,NCI-H94-0372
Study Start Date: August 1990
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002553
Other Leukemia Studies:
1. T-Cell-Depleted Allogeneic Stem Cell Transplantation Followed By Treated Donor T Cells After Immunoablative Induction Chemotherapy and Reduced-Intensity Transplantation Conditioning in Treating Patients With Hematologic Malignancies
2. 506U78 in Treating Patients With Hematologic Cancer and Kidney or Liver Impairment
3. Quality of Life in Children Treated for Cancer
4. XK469 in Treating Patients With Advanced Solid Tumors or Lymphoma
5. Rebeccamycin Analog and Cisplatin With or Without Filgrastim in Treating Patients With Advanced Cancer
Related Studies:
Other Leukemia Clinical Trials
Other Washington Clinical Trials
Other Seattle Clinical Trials
Chemotherapy Plus Radiation Therapy and Biological Therapy in Treating Patients With Hematologic Cancer
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