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BMS-214662 in Treating Patients With Acute Leukemia, Myelodysplastic Syndrome, or Chronic Myeloid Leukemia Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on BMS-214662 in Treating Patients With Acute Leukemia, Myelodysplastic Syndrome, or Chronic Myeloid Leukemia conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. BMS-214662 in Treating Patients With Acute Leukemia, Myelodysplastic Syndrome, or Chronic Myeloid Leukemia Clinical research trials and BMS-214662 in Treating Patients With Acute Leukemia, Myelodysplastic Syndrome, or Chronic Myeloid Leukemia 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 measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like BMS-214662 in Treating Patients With Acute Leukemia, Myelodysplastic Syndrome, or Chronic Myeloid Leukemia. BMS-214662 in Treating Patients With Acute Leukemia, Myelodysplastic Syndrome, or Chronic Myeloid Leukemia Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a BMS-214662 in Treating Patients With Acute Leukemia, Myelodysplastic Syndrome, or Chronic Myeloid Leukemia clinical trial. Subjects typically recieve the finest healthcare available for their BMS-214662 in Treating Patients With Acute Leukemia, Myelodysplastic Syndrome, or Chronic Myeloid Leukemia condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "B" Clinical Trials Conditions > BMS-214662 in Treating Patients With Acute Leukemia, Myelodysplastic Syndrome, or Chronic Myeloid Leukemia  BMS-214662 in Treating Patients With Acute Leukemia, Myelodysplastic Syndrome, or Chronic Myeloid Leukemia
BMS-214662 in Treating Patients With Acute Leukemia, Myelodysplastic Syndrome, or Chronic Myeloid Leukemia
For Condition: recurrent childhood acute lymphoblastic leukemia,recurrent childhood acute myeloid leukemia,refractory anemia with excess blasts in transformation,relapsing chronic myelogenous leukemia,recurrent adult acute myeloid leukemia,adult acute promyelocytic leukemia (M3),recurrent adult acute lymphoblastic leukemia,previously treated myelodysplastic syndromes,refractory anemia with excess blasts,blastic phase chronic myelogenous leukemia
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , M.D. Anderson Cancer Center
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of BMS-214662 in treating patients who have acute leukemia, myelodysplastic syndrome, or chronic myeloid leukemia in blast phase.
Details: OBJECTIVES: I. Determine the maximum tolerated dose and dose limiting toxicity of BMS-214662 in patients with acute leukemia, myelodysplastic syndrome, or chronic myeloid leukemia in blast phase. II. Determine any preliminary evidence of antileukemia activity of this drug in these patients. PROTOCOL OUTLINE: This is a dose escalation study. Patients receive BMS-214662 IV over 1 hour weekly for 4 weeks. Treatment continues every 4 weeks for a maximum of 12 courses in the absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients receive escalating doses of BMS-214662 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities. PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study within 10 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 15 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Acute myeloid leukemia, acute lymphocytic leukemia, or high risk myelodysplastic syndrome (refractory anemia with excess blasts (RAEB) or RAEB in transformation) that has: Not responded (no complete remission (CR)) to initial induction chemotherapy OR Recurred after an initial CR of less than 1 year OR Recurred after an initial CR of greater than 1 year and failed to respond to an initial reinduction attempt OR Recurred more than once OR Chronic myeloid leukemia in myeloid blast phase that has: Not received prior therapy for blast phase OR Failed other prior treatments for blast phase - Refractory or relapsed acute promyelocytic leukemia allowed provided failed a prior tretinoin containing regimen - Not likely to benefit from allogeneic bone marrow transplantation (i.e., 60 years of physiologic age or over or with no histocompatible donor) --Prior/Concurrent Therapy-- - Biologic therapy: See Disease Characteristics - Chemotherapy: See Disease Characteristics; At least 4 weeks since prior chemotherapy (unless evidence of rapidly progressive disease) and recovered; At least 24 hours since prior hydroxyurea for rapidly proliferative disease - Endocrine therapy: Not specified - Radiotherapy: Not specified - Surgery: Not specified --Patient Characteristics-- - Age: 15 and over - Performance status: 0-2 - Life expectancy: Not specified - Hematopoietic: Not specified - Hepatic: Bilirubin no greater than 1.5 mg/dL - Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min - Cardiovascular: No prolonged QTc interval on EKG - Other: Not pregnant or nursing; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JorgeCortes, Study Chair, M.D. Anderson Cancer Center
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Additional Information:
Study ID Numbers: CDR0000067887; MDA-DM-99290,NCI-450
Study Start Date: July 2000
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006213
Other Blastic Phase Chronic Myelogenous Leukemia Studies:
1. Combination Chemotherapy Plus PSC-833 in Treating Children With Refractory or Relapsed Acute Leukemia
2. Gemcitabine in Treating Children With Relapsed or Refractory Acute Lymphoblastic Leukemia or Acute Myelogenous Leukemia
3. STI571 in Treating Patients With Recurrent Leukemia
4. FR901228 in Treating Children with Refractory or Recurrent Solid Tumors or Leukemia
5. Graft-Versus-Host Disease Prevention in Treating Patients Who Are Undergoing Bone Marrow Transplantation
Related Studies:
Other blastic phase chronic myelogenous leukemia Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
BMS-214662 in Treating Patients With Acute Leukemia, Myelodysplastic Syndrome, or Chronic Myeloid Leukemia
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