|
Combination Chemotherapy in Treating Patients With Chronic Myelogenous Leukemia or Recurrent Acute Leukemia Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Combination Chemotherapy in Treating Patients With Chronic Myelogenous Leukemia or Recurrent Acute Leukemia conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Combination Chemotherapy in Treating Patients With Chronic Myelogenous Leukemia or Recurrent Acute Leukemia Clinical research trials and Combination Chemotherapy in Treating Patients With Chronic Myelogenous Leukemia or Recurrent Acute Leukemia medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Combination Chemotherapy in Treating Patients With Chronic Myelogenous Leukemia or Recurrent Acute Leukemia. Combination Chemotherapy in Treating Patients With Chronic Myelogenous Leukemia or Recurrent Acute Leukemia Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Combination Chemotherapy in Treating Patients With Chronic Myelogenous Leukemia or Recurrent Acute Leukemia clinical trial. Participants oftentimes recieve the finest healthcare available for their Combination Chemotherapy in Treating Patients With Chronic Myelogenous Leukemia or Recurrent Acute Leukemia condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "C" Clinical Trials Conditions > Combination Chemotherapy in Treating Patients With Chronic Myelogenous Leukemia or Recurrent Acute Leukemia  Combination Chemotherapy in Treating Patients With Chronic Myelogenous Leukemia or Recurrent Acute Leukemia
Combination Chemotherapy in Treating Patients With Chronic Myelogenous Leukemia or Recurrent Acute Leukemia
For Condition: Leukemia, Myeloid, Aggressive-Phase,Neutropenia,recurrent adult acute lymphoblastic leukemia,relapsing chronic myelogenous leukemia,recurrent adult acute myeloid leukemia,blastic phase chronic myelogenous leukemia
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Mayo Clinic Cancer Center
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy with carboplatin and topotecan in treating patients with chronic myelogenous leukemia or recurrent acute leukemia.
Details: OBJECTIVES: I. Estimate the maximum tolerated dose of carboplatin plus topotecan given as a 5-day continuous infusion in patients with recurrent acute lymphocytic or myeloid leukemia or accelerated or blastic phase chronic myelogenous leukemia. II. Assess the toxicity of this regimen in these patients. III. Gather preliminary information on the activity of this regimen in these patients. IV. Examine the pharmacokinetics of topotecan when administered concurrently with carboplatin. PROTOCOL OUTLINE: This is a dose escalation study of topotecan. Patients are stratified according to prior bone marrow transplant (BMT) (yes vs no). Induction: Patients receive carboplatin and topotecan IV 3 times a day on days 1-5. Patients may also receive filgrastim (G-CSF) beginning on day 7 or 14. Retreatment is based on results of marrow exam on day 10-14. Patients with less than 5% blasts undergo a second marrow exam upon blood count recovery or on day 26-30, whichever is earlier. Patients with at least 5% blasts after day 21 receive one more course, in the absence of unacceptable toxicity and at the discretion of the investigator. Patients with no greater than 5% blasts begin G-CSF if blood counts are not recovered, then proceed to consolidation. Cohorts of 1-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of up to 6 patients experience dose limiting toxicity. Patients with prior BMT will not be entered at any level until 3-6 patients with no prior BMT tolerate that level. Consolidation (begins around day 42 of last Induction course): Patients with ALL/AML in complete remission (CR) or CML in chronic phase receive 2 additional courses (same doses) 6-8 weeks apart. Patients experiencing a relapse after CR lasting at least 6 months may receive additional treatment. PROJECTED ACCRUAL: A total of 15-20 patients without and 2-20 patients with prior bone marrow transfer will be accrued for this study over 2-2.5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Acute lymphocytic or myeloid leukemia (ALL or AML) in 1 of the following categories: - Failed to achieve a complete response (CR) with initial induction regimen - First relapse within 1 year of initial CR - Failed re-induction therapy at first relapse - Second relapse after no more than 2 different induction regimens - Relapse defined as more than 10% blasts in marrow or circulating blasts in peripheral blood and either: Symptoms of recurrence (e.g., B symptoms) or Evidence of impending marrow failure (i.e., cytopenias) OR Chronic myelogenous leukemia in accelerated or blastic phase after no more than 1 prior induction regimen No HLA-identical sibling marrow donor or patient ineligible for allogeneic marrow transplantation No clinical symptoms of CNS leukemia - Patients with history of CNS leukemia must have pretreatment lumbar puncture demonstrating absence of active CNS disease No active CNS disease --Prior/Concurrent Therapy-- Biologic therapy: See Disease Characteristics Chemotherapy: - See Disease Characteristics - At least 24 hours since prior hydroxyurea for impending leukostasis - No concurrent hydroxyurea glucocorticoids - Recovered from prior chemotherapy Endocrine therapy: - At least 24 hours since prior glucocorticoids for impending leukostasis - At least 7 days since prior amphotericin or aminoglycosides - No concurrent glucocorticoids Radiotherapy: Not specified Surgery: Not specified Other: No concurrent aminoglycoside antibiotics --Patient Characteristics-- Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 4 weeks Hematologic: Not applicable Hepatic: Bilirubin less than 2 mg/dL Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: - No congestive heart failure - No poorly controlled arrhythmia - No myocardial infarction within the past 3 months Other: - No active infection - No other serious medical condition that would prevent compliance - Not pregnant or nursing - Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ScottKaufmann, Study Chair, Mayo Clinic Cancer Center
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
Additional Information:
Study ID Numbers: CDR0000064447; MAYO-958101,NCI-T95-0050H
Study Start Date: October 1995
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002693
Other Relapsing Chronic Myelogenous Leukemia Studies:
1. Gemtuzumab Ozogamicin and High-Dose Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
2. Donor Bone Marrow Transplantation in Treating Patients With Hematologic Cancer
3. Graft-Versus-Host Disease Prevention in Treating Patients Who Are Undergoing Bone Marrow Transplantation
4. Bone Marrow Transplantation in Treating Patients With Acute Leukemia in First or Second Remission
5. BMS-214662 in Treating Patients With Acute Leukemia, Myelodysplastic Syndrome, or Chronic Myeloid Leukemia
Related Studies:
Other relapsing chronic myelogenous leukemia Clinical Trials
Other Minnesota Clinical Trials
Other Rochester Clinical Trials
Combination Chemotherapy in Treating Patients With Chronic Myelogenous Leukemia or Recurrent Acute Leukemia
|
|
|
|
|
|
|
|
