|
3-AP Followed By Fludarabine In Treating Patients With Relapsed or Refractory Acute or Chronic Leukemia or High-Risk Myelodysplastic Syndrome Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about 3-AP Followed By Fludarabine In Treating Patients With Relapsed or Refractory Acute or Chronic Leukemia or High-Risk Myelodysplastic Syndrome conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. 3-AP Followed By Fludarabine In Treating Patients With Relapsed or Refractory Acute or Chronic Leukemia or High-Risk Myelodysplastic Syndrome Clinical research trials and 3-AP Followed By Fludarabine In Treating Patients With Relapsed or Refractory Acute or Chronic Leukemia or High-Risk Myelodysplastic Syndrome healthcare trials happen in hundreds of localities throughout 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 usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as 3-AP Followed By Fludarabine In Treating Patients With Relapsed or Refractory Acute or Chronic Leukemia or High-Risk Myelodysplastic Syndrome. 3-AP Followed By Fludarabine In Treating Patients With Relapsed or Refractory Acute or Chronic Leukemia or High-Risk Myelodysplastic Syndrome Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a 3-AP Followed By Fludarabine In Treating Patients With Relapsed or Refractory Acute or Chronic Leukemia or High-Risk Myelodysplastic Syndrome clinical trial. Subjects frequently obtain the most expert healthcare possible for their 3-AP Followed By Fludarabine In Treating Patients With Relapsed or Refractory Acute or Chronic Leukemia or High-Risk Myelodysplastic Syndrome condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "3" Clinical Trials Conditions > 3-AP Followed By Fludarabine In Treating Patients With Relapsed or Refractory Acute or Chronic Leukemia or High-Risk Myelodysplastic Syndrome  3-AP Followed By Fludarabine In Treating Patients With Relapsed or Refractory Acute or Chronic Leukemia or High-Risk Myelodysplastic Syndrome
3-AP Followed By Fludarabine In Treating Patients With Relapsed or Refractory Acute or Chronic Leukemia or High-Risk Myelodysplastic Syndrome
For Condition: acute leukemia,chronic leukemia,adult acute monocytic leukemia,myelodysplastic and myeloproliferative disease,atypical chronic myeloid leukemia,Prolymphocytic Leukemia
Status: Recruiting
Sponsor(s): Sidney Kimmel Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy, such as fludarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. 3-AP may help fludarabine kill more cancer cells by making them more sensitive to the drug. PURPOSE: Phase I trial to study the effectiveness of 3-AP followed by fludarabine in treating patients who have relapsed or refractoryacute leukemia, chronic leukemia, or high-riskmyelodysplastic syndrome.
Details: OBJECTIVES: - Determine the feasibility and tolerability of 3-AP (Triapine^® ) followed by fludarabine in patients with relapsed or refractory acute or chronic leukemia or high-risk myelodysplastic syndromes. - Determine the toxic effects of this regimen in these patients. - Determine the maximum tolerated dose of this regimen in these patients. OUTLINE: This is a multicenter, dose-escalation study of fludarabine. Patients are stratified according to disease (acute leukemias and myelodysplastic syndromes vs chronic lymphocytic leukemia and prolymphocytic leukemia). Patients receive 3-AP (Triapine^®) IV over 4 hours and fludarabine IV over 30 minutes on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of fludarabine 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. Once the MTD is determined, 10 additional patients are treated at that dose level. PROJECTED ACCRUAL: A total of 3-34 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed diagnosis of 1 of the following: - High-risk myelodysplastic syndromes (MDS), including refractory anemia with excess blasts and chronic myelomonocytic leukemia - International Prognostic Scoring System (IPSS) score at least 1.5 based on the following: - More than 10% marrow blasts - Cytopenias in at least 2 lineages - Adverse cytogenetics - Acute myeloid leukemia (AML) - All subtypes, including MDS/AML and treatment-related (secondary) AML - Acute lymphoblastic leukemia - Acute progranulocytic leukemia - Ineligible for arsenic therapy - Chronic myelogenous leukemia - Accelerated phase or blastic crisis - Chronic lymphocytic leukemia - Prolymphocytic leukemia - Received or ineligible for established curative regimens, including stem cell transplantation - Acute and chronic leukemias must be relapsed and/or refractory with progressive disease since last therapy PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - Not specified Hematopoietic - No history of hemolytic anemia grade 2 or greater - No known G6PD deficiency Hepatic - SGOT and SGPT no greater than 2.5 times normal - Bilirubin no greater than 2 mg/dL - No chronic hepatitis Renal - Creatinine no greater than 1.5 times normal - Creatinine clearance at least 70 mL/min Cardiovascular - No active heart disease - No myocardial infarction within the past 3 months - No severe coronary artery disease - No arrhythmias (other than atrial flutter or fibrillation) requiring medication - No uncontrolled congestive heart failure Pulmonary - No dyspnea at rest or with minimal exertion - No severe pulmonary disease requiring supplemental oxygen Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No neuropathy grade 2 or greater - No active uncontrolled infection - Infections under active treatment and controlled by antibiotics are allowed - No other life-threatening illness - No psychiatric illness that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics - At least 1 week since prior hematopoietic growth factor (e.g., epoetin alfa, filgrastim [G-CSF], sargramostim [GM-CSF], interleukin-3, and interleukin-11) - No concurrent immunotherapy Chemotherapy - Recovered from prior chemotherapy (no greater than grade 1 chronic toxic effects) - At least 72 hours since prior hydroxyurea - At least 3 weeks since prior myelosuppressive cytotoxic agents (6 weeks for mitomycin or nitrosoureas) - No more than 12 prior courses of fludarabine - No more than 3 prior cytotoxic chemotherapy regimens - No other concurrent chemotherapy Endocrine therapy - Not specified Radiotherapy - At least 2 weeks since prior radiotherapy - No concurrent radiotherapy Surgery - Not specified Other - At least 1 week since prior non-myelosuppressive treatment - No more than 4 prior induction regimens - No other concurrent therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JudithKarp, Study Chair, Sidney Kimmel Cancer Center
Marlene and Stewart Greenebaum Cancer Center, University of Maryland *Recruiting*
Baltimore, Maryland, 21201
United States
Recruiting Ivana Gojo 410-328-2565
University of Texas - MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030-4095
United States
Recruiting Francis Giles 713-792-7305
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins *Recruiting*
Baltimore, Maryland, 21231
United States
Recruiting Judith Karp 410-502-7726
Additional Information:
Study ID Numbers: CDR0000352322; NCI-6255,JHOC-J0357
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00077558
Other Adult Acute Monocytic Leukemia Studies:
1. Chemotherapy With or Without Gemtuzumab Ozogamicin in Treating Older Patients With Acute Myeloid Leukemia
2. Peripheral Stem Cell Transplantation in Treating Older Patients With Acute Myeloid Leukemia
3. Cyclosporine, Daunorubicin, and Cytarabine in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia
4. Fludarabine and Busulfan Followed by Allogeneic Stem Cell Transplantation in Treating Older Patients With Acute Myeloid Leukemia in First Complete Remission
5. Combination Chemotherapy With or Without Monoclonal Antibody Therapy Followed by Stem Cell Transplantation in Treating Patients With Acute Myeloid Leukemia
Related Studies:
Other adult acute monocytic leukemia Clinical Trials
Other Maryland Clinical Trials
Other Baltimore Clinical Trials
3-AP Followed By Fludarabine In Treating Patients With Relapsed or Refractory Acute or Chronic Leukemia or High-Risk Myelodysplastic Syndrome
|
|
|
|
|
|
|
|
