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Augmerosen Plus Fludarabine and Cytarabine in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Augmerosen Plus Fludarabine and Cytarabine in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Augmerosen Plus Fludarabine and Cytarabine in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia Clinical research trials and Augmerosen Plus Fludarabine and Cytarabine in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Augmerosen Plus Fludarabine and Cytarabine in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia. Augmerosen Plus Fludarabine and Cytarabine in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Augmerosen Plus Fludarabine and Cytarabine in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia clinical trial. Subjects frequently get the best healthcare possible for their Augmerosen Plus Fludarabine and Cytarabine in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > Augmerosen Plus Fludarabine and Cytarabine in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia  Augmerosen Plus Fludarabine and Cytarabine in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia
Augmerosen Plus Fludarabine and Cytarabine in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia
For Condition: recurrent adult acute myeloid leukemia,recurrent adult acute lymphoblastic leukemia
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Gene therapy such as augmerosen may make cancer cells more sensitive to chemotherapy drugs. Combining more than one drug with augmerosen may kill more cancer cells. PURPOSE: Phase I trial to study the effectiveness of augmerosen plus fludarabine and cytarabine in treating patients who have refractory or relapsed acute myeloid leukemia or acute lymphoblastic leukemia.
Details: OBJECTIVES: I. Determine the maximum tolerated dose of fludarabine and cytarabine when combined with augmerosen (G3139) in patients with refractory or relapsed acute myeloid leukemia or acute lymphoblastic leukemia and recommend a starting dose for phase II studies. II. Determine the qualitative and quantitative toxic effects of this regimen in these patients with regard to organ specificity, time course, predictability, and reversibility. III. Document the therapeutic response in patients treated with this regimen. IV. Measure bcl-2 and related antiapoptotic and proapoptotic proteins in circulating and/or marrow leukemia cells before, during, and after treatment with G3139. V. Measure WT1 expression in leukemic blasts as a surrogate marker for minimal residual disease and correlate it with bcl-2 and related antiapoptotic and proapoptotic gene expression. VI. Determine the time required for bcl-2 levels to recover after treatment with this regimen. VII. Determine if TP53 mutations are present in leukemic blasts and how these mutations may affect expression of BAX, level of treatment induced apoptosis, and clinical endpoints. VIII. Assess apoptosis in leukemic cells before, during, and after treatment with this regimen. IX. Determine the pharmacokinetics of fludarabine and cytarabine in patients treated with this regimen. X. Perform pharmacodynamic studies of fludarabine and cytarabine on the leukemic cells of patients prior to treatment. PROTOCOL OUTLINE: This is a dose-escalation study of fludarabine and cytarabine. Patients receive augmerosen IV continuously on days 1-10 and filgrastim (G-CSF) subcutaneously beginning on day 5 and continuing until blood counts recover. Patients receive fludarabine IV over 30 minutes followed 3.5 hours later by cytarabine IV over 4 hours on days 6-10. Patients who achieve complete response (CR) receive a second course beginning 4 weeks after completion of the first course. Patients who achieve CR and have a matched sibling or unrelated bone marrow donor may undergo allogeneic bone marrow transplantation. Cohorts of 3-6 patients receive escalating doses of fludarabine and cytarabine 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 toxicity. PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 16 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven refractory or relapsed acute myeloid leukemia or acute lymphoblastic leukemia; Marrow cellularity must be at least 20% - Must have diagnostic lumbar puncture and treatment with prophylactic intrathecal methotrexate within 1 week prior to entering study - No active CNS involvement; CNS involvement allowed if no residual leukemic cells are detected in CSF following intrathecal chemotherapy --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: See Disease Characteristics; At least 2 weeks since prior chemotherapy except hydroxyurea - Endocrine therapy: No concurrent corticosteroids except for grade 4 toxicity unresponsive to all other agents - Radiotherapy: At least 4 weeks since prior radiotherapy - Surgery: Not specified - Other: No other concurrent investigational or standard agents or therapies for leukemia --Patient Characteristics-- - Age: 16 and over - Performance status: ECOG 0-2 - Life expectancy: At least 4 weeks - Hematopoietic: See Disease Characteristics - Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN)*; ALT and AST no greater than 2 times ULN*; Alkaline phosphatase no greater than 2 times ULN* (* Unless attributable to malignancy) - Renal: Creatinine no greater than 1.5 mg/dL unless attributable to malignancy - Cardiovascular: No symptomatic congestive heart failure; No unstable angina pectoris No or cardiac arrhythmia; Resting cardiac ejection fraction no less than 45% unless attributable to malignancy - Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception before and during study; No history of allergy to study medications; No uncontrolled concurrent illness; No active infection; No serious medical or psychiatric illness that would preclude informed consent or limit survival to less than 4 weeks
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GuidoMarcucci, Study Chair, Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
United States
Additional Information:
Study ID Numbers: CDR0000067515; OSU-99H0257,NCI-T99-0057,OSU-9977
Study Start Date: October 1999
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004862
Other Recurrent Adult Acute Lymphoblastic Leukemia Studies:
1. Monoclonal Antibody Therapy in Treating Patients With Chronic Lymphocytic Leukemia, Lymphocytic Lymphoma, Acute Lymphoblastic Leukemia, or Acute Myeloid Leukemia
2. Monoclonal Antibody Therapy, Cyclophosphamide, and Total-Body Irradiation Followed by Peripheral Stem Cell Transplantation in Treating Patients With Advanced Recurrent Acute Lymphocytic Leukemia
3. Chemotherapy Followed by Donor White Blood Cells Plus Interleukin-2 in Treating Patients With Acute Myeloid or Lymphocytic Leukemia
4. Flavopiridol, Cytarabine, and Mitoxantrone in Treating Patients With Acute Leukemia
5. 3-AP and High-Dose Cytarabine in Treating Patients With Advanced Hematologic Malignancies
Related Studies:
Other recurrent adult acute lymphoblastic leukemia Clinical Trials
Other Ohio Clinical Trials
Other Columbus Clinical Trials
Augmerosen Plus Fludarabine and Cytarabine in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia
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