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Fludarabine, Carboplatin, and Topotecan in Treating Patients With Relapsed or Refractory Acute Leukemia or Advanced Myelodysplastic Syndrome 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 Fludarabine, Carboplatin, and Topotecan in Treating Patients With Relapsed or Refractory Acute Leukemia or Advanced Myelodysplastic Syndrome conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Fludarabine, Carboplatin, and Topotecan in Treating Patients With Relapsed or Refractory Acute Leukemia or Advanced Myelodysplastic Syndrome Clinical research trials and Fludarabine, Carboplatin, and Topotecan in Treating Patients With Relapsed or Refractory Acute Leukemia or Advanced Myelodysplastic Syndrome 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 Fludarabine, Carboplatin, and Topotecan in Treating Patients With Relapsed or Refractory Acute Leukemia or Advanced Myelodysplastic Syndrome. Fludarabine, Carboplatin, and Topotecan in Treating Patients With Relapsed or Refractory Acute Leukemia or Advanced Myelodysplastic Syndrome 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 Fludarabine, Carboplatin, and Topotecan in Treating Patients With Relapsed or Refractory Acute Leukemia or Advanced Myelodysplastic Syndrome clinical trial. Subjects often receive the most expert healthcare possible for their Fludarabine, Carboplatin, and Topotecan in Treating Patients With Relapsed or Refractory Acute Leukemia or Advanced Myelodysplastic Syndrome 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 > "F" Clinical Trials Conditions > Fludarabine, Carboplatin, and Topotecan in Treating Patients With Relapsed or Refractory Acute Leukemia or Advanced Myelodysplastic Syndrome  Fludarabine, Carboplatin, and Topotecan in Treating Patients With Relapsed or Refractory Acute Leukemia or Advanced Myelodysplastic Syndrome
Fludarabine, Carboplatin, and Topotecan in Treating Patients With Relapsed or Refractory Acute Leukemia or Advanced Myelodysplastic Syndrome
For Condition: Leukemia
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Ireland 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 fludarabine, carboplatin, and topotecan in treating patients who have relapsed or refractory acute leukemia or advanced myelodysplastic syndrome.
Details: OBJECTIVES: I. Determine the maximum tolerated dose of topotecan when administered with carboplatin and fludarabine in patients with refractory or relapsed acute leukemia or advanced myelodysplastic syndrome. II. Determine treatment related and dose limiting toxicities of this regimen in these patients. III. Determine the antileukemia activity of this regimen in these patients. IV. Correlate treatment related toxicities with steady state levels of topotecan in these patients. PROTOCOL OUTLINE: This is a dose escalation study of topotecan. Patients receive carboplatin IV continuously and fludarabine IV over 30 minutes on days 1-5, then topotecan IV continuously on days 6-8. Patients with residual leukemia in the bone marrow at day 15 may receive a second induction course. Patients who achieve partial or complete remission after 1-2 induction courses receive 1 consolidation course of fludarabine, carboplatin, and topotecan beginning 4-8 weeks after recovery from induction therapy. Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined. The first 3 patients do not receive any topotecan. The MTD is defined as the dose at which no more than 2 of 6 patients experience dose limiting toxicity. Patients are followed monthly for 6 months. PROJECTED ACCRUAL: A total of 6-15 patients will be accrued for this study within 15-21 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 12 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Diagnosis of one of the following: Acute myelogenous leukemia (M0-M7); M3 must have received tretinoin as part of induction or salvage chemotherapy; No greater than 2 prior intensive induction regimens; Acute lymphocytic leukemia (L1 or L2) in first or second relapse; Circulating blasts in blood or greater than 5% blasts in bone marrow; No greater than 2 prior intensive induction regimens; Chronic myelogenous leukemia in myeloid or lymphoid blast crisis; Initial diagnosis OR No greater than 2 prior intensive induction regimens; Acute myelogenous leukemia secondary to prior myelodysplastic syndrome or prior cytotoxic therapy; No greater than 2 prior intensive induction regimens; Myelodysplastic syndrome (must be neutropenic (absolute neutrophil count less than 500/mm3) or platelet or red cell transfusion dependent) Refractory anemia with excess blasts (RAEB) OR RAEB in transformation OR Chronic myelomonocytic leukemia - Relapse after greater than 3 months since prior autologous stem cell transplant allowed - No relapse after allogeneic bone marrow transplant - No active CNS leukemia --Prior/Concurrent Therapy-- - Biologic therapy: See Disease Characteristics; At least 5 days since prior hematopoietic growth factors - Chemotherapy: See Disease Characteristics; At least 24 hours since prior hydroxyurea; At least 2 weeks since other prior cytotoxic anticancer therapy; Prior carboplatin, fludarabine, or topotecan allowed - Endocrine therapy: Concurrent corticosteroids allowed - Radiotherapy: Not specified - Surgery: Not specified --Patient Characteristics-- - Age: 12 and over - Performance status: ECOG 0-3 - Life expectancy: At least 4 weeks - Hematopoietic: See Disease Characteristics - Hepatic: Bilirubin no greater than 2.0 mg/dL; AST and ALT less than 3 times upper limit of normal - Renal: Creatinine clearance at least 50 mL/min - Cardiovascular: No symptomatic cardiac disease; No active ischemic heart disease; No poorly controlled congestive heart failure; No myocardial infarction within past 6 months; Cardiac ejection fraction at least 40% - Pulmonary: No symptomatic pulmonary disease; No symptomatic restrictive or obstructive lung disease - Other: Not pregnant or nursing; Fertile patients must use effective contraception; No active infections, unless receiving antibiotics and clinically stable; Fever caused by tumor allowed; HIV negative; No other active malignant disease; Curatively treated prior malignancies allowed; No severe neurologic disease
Total Enrollment:
Location and Contact Information:
Overall Study Official:
BrendaCooper, Study Chair, Ireland Cancer Center
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
United States
Additional Information:
Study ID Numbers: CDR0000067699; CWRU-059812,NCI-G00-1732,CWRU-1998
Study Start Date: September 1998
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005593
Other Leukemia Studies:
1. A Trial of Carboxypeptidase-G2 (CPDG2) for the Management of Patients with Intrathecal Methotrexate Overdose
2. Lymphocyte Infusion in Treating Patients With Relapsed Cancer After Bone Marrow or Peripheral Stem Cell Transplantation
3. Sleep, Fatigue, and Dexamethosone in Children with Leukemia
4. Chemotherapy, Radiation Therapy, and Umbilical Cord Blood Transplantation in Treating Patients With Hematologic Cancer
5. Total-Body Irradiation, Tacrolimus, and Mycophenolate Mofetil Plus Bone Marrow Transplantation in Treating Patients With Hematologic Cancers
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Fludarabine, Carboplatin, and Topotecan in Treating Patients With Relapsed or Refractory Acute Leukemia or Advanced Myelodysplastic Syndrome
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