|
3-AP and High-Dose Cytarabine in Treating Patients With Advanced Hematologic Malignancies Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about 3-AP and High-Dose Cytarabine in Treating Patients With Advanced Hematologic Malignancies conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. 3-AP and High-Dose Cytarabine in Treating Patients With Advanced Hematologic Malignancies Clinical research trials and 3-AP and High-Dose Cytarabine in Treating Patients With Advanced Hematologic Malignancies medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as 3-AP and High-Dose Cytarabine in Treating Patients With Advanced Hematologic Malignancies. 3-AP and High-Dose Cytarabine in Treating Patients With Advanced Hematologic Malignancies Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a 3-AP and High-Dose Cytarabine in Treating Patients With Advanced Hematologic Malignancies clinical trial. Participants frequently get the best healthcare available for their 3-AP and High-Dose Cytarabine in Treating Patients With Advanced Hematologic Malignancies condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "3" Clinical Trials Conditions > 3-AP and High-Dose Cytarabine in Treating Patients With Advanced Hematologic Malignancies  3-AP and High-Dose Cytarabine in Treating Patients With Advanced Hematologic Malignancies
3-AP and High-Dose Cytarabine in Treating Patients With Advanced Hematologic Malignancies
For Condition: relapsing chronic myelogenous leukemia,accelerated phase chronic myelogenous leukemia,recurrent adult acute myeloid leukemia,recurrent adult acute lymphoblastic leukemia,secondary acute myeloid leukemia,blastic phase chronic myelogenous leukemia
Status: Recruiting
Sponsor(s): University of Chicago Cancer Research Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy, such as cytarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. 3-AP may help cytarabine kill more cancer cells by making them more sensitive to the drug. PURPOSE: Phase I trial to study the effectiveness of combining 3-AP with high-dose cytarabine in treating patients who have advanced hematologic malignancies.
Details: OBJECTIVES: Primary - Determine the maximum tolerated dose of 3-AP (Triapine®) administered with high-dose cytarabine in patients with advanced hematologic malignancies. Secondary - Determine the clinical activity of this regimen in these patients. - Determine the effect of treatment with 3-AP (Triapine®) on intracellular levels of cytarabine in these patients. OUTLINE: This is a dose-escalation study of 3-AP (Triapine®). Patients are stratified according to adequate hematopoiesis, defined as absolute neutrophil count > 1,000/mm^3 and platelet count > 50,000/mm^3 (yes vs no). Patients receive high-dose cytarabine IV over 2 hours on days 1-5 and 3-AP (Triapine®) IV over 2 hours on days 2-5. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients in each stratum receive escalating doses of 3-AP (Triapine®) until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed for up to 2 years. PROJECTED ACCRUAL: A total of 6-48 patients (3-24 per stratum) will be accrued for this study within 15-24 months.
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 hematologic malignancies: - Relapsed or refractory acute myeloid leukemia (AML) - Relapsed or refractory acute lymphoblastic leukemia - Secondary AML, including AML arising from antecedent hematologic diseases, such as myelodysplastic syndromes or myeloproliferative disorders OR therapy-related AML - Chronic myeloid leukemia in accelerated or blast phase - Refractory to standard therapy or no standard therapy exists - No known brain metastases PATIENT CHARACTERISTICS: Age - 18 and over Performance status - CALGB 0-2 OR - Karnofsky 60-100% Life expectancy - Not specified Hematopoietic - No G6PD deficiency Hepatic - Bilirubin < 2.0 mg/dL (unless due to Gilbert’s syndrome) - AST and ALT < 2.5 times upper limit of normal (ULN) Renal - Creatinine < 1.5 times ULN Cardiovascular - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Pulmonary - No pulmonary disease requiring oxygen Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No prior allergic reactions attributed to compounds of similar chemical or biological composition to study drugs - No neuropathy - No ongoing or active infection - No psychiatric illness or social situation that would preclude study compliance - No other concurrent uncontrolled illness PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent biologic agents Chemotherapy - At least 72 hours since prior hydroxyurea - At least 2 weeks since other prior chemotherapy (6 weeks for mitomycin or nitrosoureas) - No other concurrent chemotherapy Endocrine therapy - Not specified Radiotherapy - At least 2 weeks since prior radiotherapy - No concurrent radiotherapy Surgery - Not specified Other - Recovered from all prior therapy - At least 4 weeks since prior investigational agents - No other concurrent investigational therapy - No other concurrent anticancer therapy - No concurrent combination antiretroviral therapy for HIV-positive patients
Total Enrollment:
Location and Contact Information:
Overall Study Official:
OlatoyosiOdenike, Principal Investigator, University of Chicago Cancer Research Center
University of Chicago Cancer Research Center *Recruiting*
Chicago, Illinois, 60637
United States
Recruiting Olatoyosi Odenike 773-702-3354
Additional Information:
Study ID Numbers: CDR0000349659; UCCRC-12806B,NCI-6283
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00077181
Other Blastic Phase Chronic Myelogenous Leukemia Studies:
1. Dolastatin 10 in Treating Patients With Refractory or Relapsed Acute Leukemia, Myelodysplastic Syndrome, or Chronic Myelogenous Leukemia
2. 3-AP and High-Dose Cytarabine in Treating Patients With Advanced Hematologic Malignancies
3. Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Lymphocytic Leukemia
4. Bone Marrow Transplantation in Treating Patients With Acute Leukemia in First or Second Remission
5. Radiolabeled Monoclonal Antibody Therapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Lymphoma or Waldenstrom's Macroglobulinemia
Related Studies:
Other blastic phase chronic myelogenous leukemia Clinical Trials
Other Illinois Clinical Trials
Other Chicago Clinical Trials
3-AP and High-Dose Cytarabine in Treating Patients With Advanced Hematologic Malignancies
|
|
|
|
|
|
|
|
