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Combination Chemotherapy Followed By Peripheral Stem Cell Transplantation or Isotretinoin in Treating Patients With Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Acute Lymphocytic Leukemia Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Combination Chemotherapy Followed By Peripheral Stem Cell Transplantation or Isotretinoin in Treating Patients With Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Acute Lymphocytic Leukemia conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Combination Chemotherapy Followed By Peripheral Stem Cell Transplantation or Isotretinoin in Treating Patients With Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Acute Lymphocytic Leukemia Clinical research trials and Combination Chemotherapy Followed By Peripheral Stem Cell Transplantation or Isotretinoin in Treating Patients With Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Acute Lymphocytic Leukemia healthcare trials take place in many of cities across 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 generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Combination Chemotherapy Followed By Peripheral Stem Cell Transplantation or Isotretinoin in Treating Patients With Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Acute Lymphocytic Leukemia. Combination Chemotherapy Followed By Peripheral Stem Cell Transplantation or Isotretinoin in Treating Patients With Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Acute Lymphocytic Leukemia Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Combination Chemotherapy Followed By Peripheral Stem Cell Transplantation or Isotretinoin in Treating Patients With Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Acute Lymphocytic Leukemia clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Combination Chemotherapy Followed By Peripheral Stem Cell Transplantation or Isotretinoin in Treating Patients With Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Acute Lymphocytic Leukemia condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy Followed By Peripheral Stem Cell Transplantation or Isotretinoin in Treating Patients With Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Acute Lymphocytic Leukemia  Combination Chemotherapy Followed By Peripheral Stem Cell Transplantation or Isotretinoin in Treating Patients With Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Acute Lymphocytic Leukemia
Combination Chemotherapy Followed By Peripheral Stem Cell Transplantation or Isotretinoin in Treating Patients With Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Acute Lymphocytic Leukemia
For Condition: Polycythemia Vera,Chronic Myelomonocytic Leukemia,refractory anemia with excess blasts,refractory anemia with ringed sideroblasts,recurrent adult acute lymphoblastic leukemia,blastic phase chronic myelogenous leukemia,Thrombocytopenia,refractory chronic myelogenous leukemia,secondary acute myeloid leukemia,secondary myelodysplastic syndrome,recurrent adult acute myeloid leukemia,Refractory Anemia,Previously Treated Myelodysplastic Syndrome,Agnogenic Myeloid Metaplasia
Status: Completed
Sponsor(s): Medical College of Pennsylvania Hospital ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Isotretinoin may help cancer cells develop into normal white blood cells. PURPOSE: Phase I/II trial of topotecan, fludarabine, cytarabine, and filgrastim followed by peripheral stem cell transplantation or isotretinoin in treating patients who have acute myeloid leukemia, myelodysplastic syndrome, or recurrent or refractory acute lymphocytic leukemia.
Details: OBJECTIVES: I. Determine the safety of topotecan in combination with fludarabine, cytarabine, and filgrastim (FLAG) in patients with poor prognosis acute myeloid leukemia, myelodysplastic syndrome, or recurrent or refractory acute lymphocytic leukemia. II. Determine the maximum tolerated dose of topotecan in the FLAG regimen in these patients. III. Assess the complete remission rates in patients treated with this regimen. PROTOCOL OUTLINE: Patients with complete response proceed to further therapy according to age. 65 and under: Patients receive etoposide by IV continuously for 5 days, cytarabine IV over 2 hours every 12 hours for 4 days, and filgrastim (G-CSF) subcutaneously. Peripheral blood stem cells (PBSC) are then harvested. Patients then receive oral busulfan every 6 hours on days -7 to -4 and etoposide IV over 10 hours on day -3. PBSC are reinfused on day 0. Over 65: Patients receive oral isotretinoin and vitamin E daily. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every month for 1 year and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study within 3-4 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 19 Years/90 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven poor prognosis acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or recurrent/refractory acute lymphocytic leukemia, including: Myelodysplastic syndrome (MDS) stages B and C; Refractory anemia, refractory anemia with ringed sideroblasts, or refractory anemia with excess blasts (between 5% and 20% myeloblasts); MDS with increased erythroblasts or monocytoblasts of no greater than 20% MDS in transformation (between 20% to 30% myeloblasts) or acute nonlymphoblastic leukemia (at least 30% myeloblasts); Chronic myelomonocytic leukemia; Poor prognosis refractory or recurrent acute myeloid leukemia after complete response; Secondary or therapy related AML or MDS AML blastic crisis of chronic myelogenous leukemia or other myeloproliferative disorders such as polycythemia vera, essential thrombocytopenia, or agnogenic myeloid metaplasia --Prior/Concurrent Therapy-- - Biologic therapy: No other concurrent immunotherapy - Chemotherapy: No prior topotecan; At least 4 weeks since prior chemotherapy; No other concurrent chemotherapy - Endocrine therapy: Not specified - Radiotherapy: No concurrent radiotherapy - Surgery: Not specified - Other: No other investigational drugs within 30 days of study; No other concurrent investigational therapy except for basal cell skin cancer --Patient Characteristics-- - Age: 19 to 90 - Performance status: ECOG 0-2 - Life expectancy: Not specified - Hematopoietic: Not specified - Hepatic: Bilirubin no greater than 2.0 mg/dL; SGOT or SGPT less than 2.0 times upper limit of normal - Renal: Normal serum creatinine - Cardiovascular: No congestive heart failure; No symptomatic ischemic heart disease - Other: Not pregnant or nursing; Fertile patients must use effective contraception; HIV negative; No uncontrolled infection; No poorly controlled diseases (e.g., diabetes, systemic lupus erythematosus); No history of psychiatric disorders; No other malignancies within the past 5 years except adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix; No concurrent severe medical problems; No history of allergic reaction to topotecan and its derivatives
Total Enrollment:
Location and Contact Information:
Overall Study Official:
EmmanuelBesa, Study Chair, Medical College of Pennsylvania Hospital
Medical College of Pennsylvania Hospital
Philadelphia, Pennsylvania, 19129
United States
Medical College of Pennsylvania
Philadelphia, Pennsylvania, 19129
United States
Additional Information:
Study ID Numbers: CDR0000066698; AUH-MCP-70612-01,NCI-V98-1485,AUH-MCP-70612-02P
Study Start Date: February 1998
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003619
Other Agnogenic Myeloid Metaplasia Studies:
1. Treatment of Autoimmune Thrombocytopenia (AITP)
2. Phase I Study of T-Cell Large Granular Lymphocytic Leukemia Using the MIK-Beta-1 Monoclonal Antibody Directed Toward the IL-2R-Beta Subunit
3. Screening for Hematology Branch Protocols
4. Cancer in Inherited Bone Marrow Failure Syndromes
5. Stem Cell Transplantation (SCT) for Genetic Diseases
Related Studies:
Other Agnogenic Myeloid Metaplasia Clinical Trials
Other Pennsylvania Clinical Trials
Other Philadelphia Clinical Trials
Combination Chemotherapy Followed By Peripheral Stem Cell Transplantation or Isotretinoin in Treating Patients With Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Acute Lymphocytic Leukemia
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