|
Amifostine and High-Dose Combination Chemotherapy in Treating Patients With Acute Myeloid Leukemia or Chronic Myelogenous Leukemia Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about Amifostine and High-Dose Combination Chemotherapy in Treating Patients With Acute Myeloid Leukemia or Chronic Myelogenous Leukemia conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Amifostine and High-Dose Combination Chemotherapy in Treating Patients With Acute Myeloid Leukemia or Chronic Myelogenous Leukemia Clinical research trials and Amifostine and High-Dose Combination Chemotherapy in Treating Patients With Acute Myeloid Leukemia or Chronic Myelogenous Leukemia healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as Amifostine and High-Dose Combination Chemotherapy in Treating Patients With Acute Myeloid Leukemia or Chronic Myelogenous Leukemia. Amifostine and High-Dose Combination Chemotherapy in Treating Patients With Acute Myeloid Leukemia or Chronic Myelogenous Leukemia Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Amifostine and High-Dose Combination Chemotherapy in Treating Patients With Acute Myeloid Leukemia or Chronic Myelogenous Leukemia clinical trial. Subjects frequently obtain the most expert healthcare possible for their Amifostine and High-Dose Combination Chemotherapy in Treating Patients With Acute Myeloid Leukemia or Chronic Myelogenous Leukemia condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "A" Clinical Trials Conditions > Amifostine and High-Dose Combination Chemotherapy in Treating Patients With Acute Myeloid Leukemia or Chronic Myelogenous Leukemia  Amifostine and High-Dose Combination Chemotherapy in Treating Patients With Acute Myeloid Leukemia or Chronic Myelogenous Leukemia
Amifostine and High-Dose Combination Chemotherapy in Treating Patients With Acute Myeloid Leukemia or Chronic Myelogenous Leukemia
For Condition: Neutropenia,secondary acute myeloid leukemia,untreated adult acute myeloid leukemia,de novo myelodysplastic syndrome,Drug Toxicity,secondary myelodysplastic syndrome,recurrent adult acute myeloid leukemia,refractory anemia with excess blasts in transformation,blastic phase chronic myelogenous leukemia
Status: No longer recruiting
Sponsor(s): Rush Cancer Institute at Rush University Medical Center ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Chemoprotective drugs, such as amifostine, may protect normal cells from the side effects of chemotherapy. PURPOSE: Phase II trial to study the effectiveness of amifostine and high-dose combination chemotherapy in treating patients with acute myeloid leukemia or chronic myelogenous leukemia.
Details: OBJECTIVES: I. Assess the effects of amifostine on the response to remission induction therapy and consolidation with cytarabine and mitoxantrone in patients with poor prognosis acute myeloid leukemia (AML), relapsed AML, and blastic phase chronic myelogenous leukemia (CML). II. Assess the effects of amifostine on the biology of AML and CML cells in vivo in this patient population. PROTOCOL OUTLINE: Patients receive treatment prior to induction therapy on protocols CYL 90-03 and CYL 97-59. Induction therapy consists of amifostine IV on days 1 and 5 and three times a week from days 6 to 28. Fifteen minutes after amifostine on days 1 and 5, patients receive cytarabine IV over 3 hours at hour 0 and hour 12 and mitoxantrone IV over 1 hour at hour 15. Patients who do not enter remission receive a second course of induction therapy. Patients with persistent AML following a second course are removed from the study. Patients who achieve a complete response (CR), clinical CR, or remission in bone marrow but without hematologic recovery or who return to myelodysplastic syndrome receive consolidation therapy. Consolidation therapy consists of amifostine IV on days 1 and 5 and then three times a week until blood counts recover or day 30, whichever comes first. Patients also receive cytarabine and mitoxantrone as in induction therapy. Patients receive a second course of consolidation therapy beginning 1 week after blood counts recover. After completion of consolidation therapy, patients are enrolled on protocol MDS 97-53. PROJECTED ACCRUAL: A maximum of 50 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Educational/Counseling/Training
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Newly diagnosed high risk acute myeloid leukemia (AML) defined as: AML after myelodysplastic syndrome; refractory anemia with excess blasts in transformation or "AML in evolution" also eligible AML following a chronic myeloproliferative disorder (except chronic myelogenous leukemia); Therapy related AML or AML following exposure to a known hematopoietic toxin; Relapsed AML Age 70 or older OR AML in first relapse defined as: AML in first relapse without treatment on protocol AML-9801; Relapsed following standard chemotherapy; Previously treated on AML-9701 and relapsed after at least 6 months of remission OR Chronic myelogenous leukemia (CML) in blast crisis defined as: 20% or more blast cells in the bone marrow or peripheral blood; Pure lymphoid blastic crisis eligible if resistant to an acute lymphocytic leukemia type treatment regimen or relapsed after initial response to such a treatment --Prior/Concurrent Therapy-- - See Disease Characteristics --Patient Characteristics-- - Age: 18 and over - Performance status: Karnofsky 60-100% - Life expectancy: Not specified - Hematopoietic: Not specified - Hepatic: Bilirubin less than 3 mg/dL; SGOT/SGPT no greater than 2.5 times upper limit of normal - Renal: Creatinine less than 3 mg/dL - Cardiovascular: No overt congestive heart failure or uncontrollable ventricular arrhythmias; No uncontrollable hypertension - Neurologic: No cerebellar dysfunction - Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HarveyPreisler, Study Chair, Rush Cancer Institute at Rush University Medical Center
Angelo P. Creticos, M.D. Cancer Center
Chicago, Illinois, 60657
United States
Cook County Hospital
Chicago, Illinois, 60612-9985
United States
Rush-Riverside Cancer Center
Kankakee, Illinois, 60901
United States
Rush Cancer Institute
Chicago, Illinois, 60612
United States
Additional Information:
Study ID Numbers: CDR0000066416; RUSH-AML-9801,NCI-V98-1447,ALZA-RUSH-AML-9801
Study Start Date: April 1998
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003407
Other Recurrent Adult Acute Myeloid Leukemia Studies:
1. Troxacitabine in Treating Patients With Chronic Myelogenous Leukemia
2. Bevacizumab, Idarubicin, and Cytarabine in Treating Patients With Blast Phase Chronic Myelogenous Leukemia
3. Bortezomib in Treating Young Patients With Refractory or Recurrent Leukemia
4. PS-341 in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Chronic Myeloid Leukemia in Blast Phase, or Myelodysplastic Syndrome
5. Flavopiridol and Imatinib Mesylate in Treating Patients With Hematologic Cancer
Related Studies:
Other recurrent adult acute myeloid leukemia Clinical Trials
Other Illinois Clinical Trials
Other Chicago Clinical Trials
Amifostine and High-Dose Combination Chemotherapy in Treating Patients With Acute Myeloid Leukemia or Chronic Myelogenous Leukemia
|
|
|
|
|
|
|
|
