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Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Acute Myeloid Leukemia in Second Remission 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 Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Acute Myeloid Leukemia in Second Remission conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Acute Myeloid Leukemia in Second Remission Clinical research trials and Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Acute Myeloid Leukemia in Second Remission 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 Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Acute Myeloid Leukemia in Second Remission. Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Acute Myeloid Leukemia in Second Remission 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 Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Acute Myeloid Leukemia in Second Remission clinical trial. Subjects often receive the most expert healthcare possible for their Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Acute Myeloid Leukemia in Second Remission 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 > "C" Clinical Trials Conditions > Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Acute Myeloid Leukemia in Second Remission  Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Acute Myeloid Leukemia in Second Remission
Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Acute Myeloid Leukemia in Second Remission
For Condition: adult acute differentiated monocytic leukemia (M5b),adult acute myeloblastic leukemia without maturation (M1),adult acute minimally differentiated myeloid leukemia (M0),adult acute poorly differentiated monocytic leukemia (M5a),adult acute erythroleukemia (M6),adult acute myeloid leukemia in remission,adult acute myelomonocytic leukemia (M4),adult acute myeloblastic leukemia with maturation (M2),adult acute megakaryocytic leukemia (M7),adult acute promyelocytic leukemia (M3)
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Cancer and Leukemia Group B
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of peripheral stem cell transplantation following chemotherapy in treating patients with acute myeloid leukemia in second remission.
Details: OBJECTIVES: I. Determine the ability of mobilization using cytarabine, etoposide, and filgrastim (G-CSF), conditioning using busulfan and etoposide, and autologous peripheral blood stem cell transplantation to generate a 2-year disease-free survival rate in at least 30% of patients with acute myeloid leukemia (AML) in second complete remission. II. Determine whether the treatment-related mortality can be limited to less than 20% in patients treated with this regimen. III. Determine whether adequate numbers of PBSC can be collected in these patients. IV. Determine the engraftment kinetics of primed PBSC obtained from these patients. PROTOCOL OUTLINE: Mobilization/harvest: Patients receive cytarabine IV over 2 hours every 12 hours and etoposide IV continuously on days 1-4. Filgrastim (G-CSF) is administered subcutaneously (SC) beginning on day 14 and continuing until peripheral blood stem cells (PBSC) are harvested. When blood counts recover, PBSC are harvested and selected for CD34+ cells. Conditioning: Beginning at least 4 weeks after hospital discharge for mobilization and harvest and when blood counts recover, patients receive oral busulfan every 6 hours on days -7 to -4 and etoposide IV over 4 hours on day -3. PBSC are reinfused on day 0. G-CSF is administered SC beginning on day 0 and continuing until blood counts recover. Patients with documented CNS disease at first relapse receive methotrexate intrathecally at intervals of 1 week or greater before and/or after PBSC transplantation for a total of 6 doses. Patients are followed every 3 months for 2 years and then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 26-48 patients will be accrued within 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 15 Years/69 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Diagnosis of acute myeloid leukemia (AML) in second complete remission (CR) for 30 days to less than 1 year before study entry; Second CR defined by the following: Neutrophil count at least 1,000/mm3; Platelet count at least 100,000/mm3; Normal bone marrow morphology with no excess blasts (greater than 5%); No myelodysplasia; No extramedullary or CNS leukemia - Initial diagnosis of de novo AML (M0-M7); No prior myelodysplasia; No myeloproliferative disease; No secondary AML - Cytogenetics not required; No cytogenetic evidence of persistent leukemia if cytogenetics performed --Prior/Concurrent Therapy-- - Biologic therapy: No prior bone marrow/stem cell transplantation - Chemotherapy: Prior non-ablative chemotherapy at initial diagnosis, during initial remission, or as reinduction therapy (to produce current second remission) allowed; At least 4 weeks since hospital discharge after reinduction therapy - Endocrine therapy: Not specified - Radiotherapy: Not specified - Surgery: Not specified - Other: No prior post-remission therapy for second remission --Patient Characteristics-- - Age: 15 to 69 - Hematopoietic: See Disease Characteristics; Granulocyte count at least 1,000/mm3 - Hepatic: Bilirubin less than 1.5 mg/dL; AST less than 3 times normal; Alkaline phosphatase less than 3 times normal; No cirrhosis or chronic hepatitis; Biopsy required if chronic liver disease suspected (history of alcohol abuse or possible hepatitis) - Renal: Creatinine less than 2.0 mg/dL - Other: Not pregnant or nursing; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
CharlesLinker, Study Chair, Cancer and Leukemia Group B
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201
United States
St. Joseph's Hospital and Medical Center
Paterson, New Jersey, 07503
United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94115-0128
United States
Additional Information:
Study ID Numbers: CDR0000064734; CLB-9620
Study Start Date: June 1996
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002768
Other Adult Acute Myeloid Leukemia In Remission Studies:
1. High Dose Chemotherapy, Peripheral Stem Cell Transplantation, and Interleukin-2 in Treating Patients With Acute Myeloid Leukemia
2. Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Acute Myeloid Leukemia in Second Remission
3. Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With Refractory or Relapsed Acute Myelogenous Leukemia
4. Combination Chemotherapy Plus Biological Therapy in Treating Patients With Acute Myelogenous Leukemia
5. Combination Chemotherapy With or Without G-CSF in Treating Older Patients With Acute Myeloid Leukemia
Related Studies:
Other adult acute myeloid leukemia in remission Clinical Trials
Other California Clinical Trials
Other San Francisco Clinical Trials
Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Acute Myeloid Leukemia in Second Remission
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