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Monoclonal Antibody, Cyclophosphamide, and Radiation Therapy Followed by Bone Marrow Transplant in Treating Patients With Advanced Acute Myeloid Leukemia or Myelodysplastic Syndrome Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about Monoclonal Antibody, Cyclophosphamide, and Radiation Therapy Followed by Bone Marrow Transplant in Treating Patients With Advanced Acute Myeloid Leukemia or Myelodysplastic Syndrome conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Monoclonal Antibody, Cyclophosphamide, and Radiation Therapy Followed by Bone Marrow Transplant in Treating Patients With Advanced Acute Myeloid Leukemia or Myelodysplastic Syndrome Clinical research trials and Monoclonal Antibody, Cyclophosphamide, and Radiation Therapy Followed by Bone Marrow Transplant in Treating Patients With Advanced Acute Myeloid Leukemia or Myelodysplastic Syndrome health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like Monoclonal Antibody, Cyclophosphamide, and Radiation Therapy Followed by Bone Marrow Transplant in Treating Patients With Advanced Acute Myeloid Leukemia or Myelodysplastic Syndrome. Monoclonal Antibody, Cyclophosphamide, and Radiation Therapy Followed by Bone Marrow Transplant in Treating Patients With Advanced Acute Myeloid Leukemia or Myelodysplastic Syndrome Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a Monoclonal Antibody, Cyclophosphamide, and Radiation Therapy Followed by Bone Marrow Transplant in Treating Patients With Advanced Acute Myeloid Leukemia or Myelodysplastic Syndrome clinical trial. Human subjects often get the best healthcare available for their Monoclonal Antibody, Cyclophosphamide, and Radiation Therapy Followed by Bone Marrow Transplant in Treating Patients With Advanced Acute Myeloid Leukemia or Myelodysplastic Syndrome condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "M" Clinical Trials Conditions > Monoclonal Antibody, Cyclophosphamide, and Radiation Therapy Followed by Bone Marrow Transplant in Treating Patients With Advanced Acute Myeloid Leukemia or Myelodysplastic Syndrome  Monoclonal Antibody, Cyclophosphamide, and Radiation Therapy Followed by Bone Marrow Transplant in Treating Patients With Advanced Acute Myeloid Leukemia or Myelodysplastic Syndrome
Monoclonal Antibody, Cyclophosphamide, and Radiation Therapy Followed by Bone Marrow Transplant in Treating Patients With Advanced Acute Myeloid Leukemia or Myelodysplastic Syndrome
For Condition: juvenile myelomonocytic leukemia,Chronic Myelomonocytic Leukemia,Myelodysplastic Syndromes,childhood acute myeloid leukemia,adult acute myeloid leukemia,secondary acute myeloid leukemia
Status: Recruiting
Sponsor(s): Fred Hutchinson Cancer Research Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining monoclonal antibody therapy with chemotherapy and radiation therapy may kill more cancer cells. Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy and radiation therapy. PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody, cyclophosphamide, total-body irradiation, and bone marrow transplant in treating patients who have advanced acute myeloid leukemia or myelodysplastic syndrome.
Details: OBJECTIVES: - Determine the efficacy and toxicity of cyclophosphamide, total body irradiation, and the maximum tolerated dose of iodine I 131 monoclonal antibody BC8 (I131 MOAB BC8) in patients with acute myeloid leukemia beyond first remission or advanced myelodysplastic syndromes receiving a HLA-matched bone marrow transplantation. - Determine the efficacy and toxicity of this regimen in patients receiving HLA-unmatched bone marrow transplantation. - Estimate the maximum tolerated dose of radiation delivered by I 131 MOAB BC8 to marrow and assess the effects on growth of marrow stroma in vitro. OUTLINE: This is radiation dose-escalation study. Patients are stratified according to available donor (related vs unrelated). Patients receive a biodistribution dose of iodine I 131 monoclonal antibody BC8 (I131 MOAB BC8) IV, then a therapeutic dose of I 131 MOAB BC8 IV 6-14 days later (day -11). Cyclophosphamide IV is administered on days -5 and -4, then patients undergo total body irradiation twice daily on days -3 to -1. Bone marrow (or peripheral blood stem cells) are infused on day 0. Patients with CNS leukemic involvement receive intrathecal methotrexate twice before the transplantation then every other week for 8 weeks beginning on day 32. These patients also receive cranial irradiation beginning on day 32. Cohorts of 4 patients each receive escalating doses of iodine I 131 attached to a standard dose of monoclonal antibody BC8 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the radiation dose below that at which 2 of up to 6 patients experience graft failure. Patients are followed at 6, 9, and 12 months, every 6 months for 1 year, and then annually thereafter. PROJECTED ACCRUAL: A total of 40 patients (20 per stratum) will be accrued for this study within 4 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 2 Years/55 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of 1 of the following: - Acute myeloid leukemia (AML) beyond first remission or with primary refractory disease - Myelodysplastic syndromes (MDS) - Refractory anemia with excess blasts (RAEB) - RAEB in transformation - Chronic myelomonocytic leukemia - AML that has transformed from MDS, if induction chemotherapy not recommended - Documented CD45 expression in patients with relapsed disease - Not needed for patients in remission - Circulating blast count less than 10,000/mm^3 (may be controlled with hydroxyurea or similar agent) PATIENT CHARACTERISTICS: Age - 2 to 55 Performance status - Not specified Life expectancy - Greater than 60 days Hematopoietic - See Disease Characteristics Hepatic - Bilirubin less than 1.5 mg/dL - AST less than 1.5 times upper limit of normal (ULN) - No hepatitis Renal - Creatinine less than 2.0 mg/dL or less than 1.5 times ULN for age Other - No major infection - No circulating antibodies to mouse immunoglobulins - HIV negative - Able to tolerate diagnostic or therapeutic procedures (e.g., radiation isolation) PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - See Disease Characteristics Endocrine therapy - Not specified Radiotherapy - No radiotherapy to maximum tolerated levels to any normal organ Surgery - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JohnPagel, Study Chair, Fred Hutchinson Cancer Research Center
Fred Hutchinson Cancer Research Center *Recruiting*
Seattle, Washington, 98109-1024
United States
Recruiting Eneida Nemecek 206-667-1816
Additional Information:
Study ID Numbers: CDR0000067032; FHCRC-1297.00,NCI-H99-0028
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003868
Other Myelodysplastic Syndromes Studies:
1. Monoclonal Antibody, Cyclophosphamide, and Radiation Therapy Followed by Bone Marrow Transplant in Treating Patients With Advanced Acute Myeloid Leukemia or Myelodysplastic Syndrome
2. Combination Chemotherapy Followed By Donor Bone Marrow or Umbilical Cord Blood Transplantation in Treating Children With Newly Diagnosed Juvenile Myelomonocytic Leukemia
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Monoclonal Antibody, Cyclophosphamide, and Radiation Therapy Followed by Bone Marrow Transplant in Treating Patients With Advanced Acute Myeloid Leukemia or Myelodysplastic Syndrome
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