|
VNP40101M and Hydroxyurea in Treating Patients With Acute Myeloid Leukemia or High-Risk Myelodysplasia Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on VNP40101M and Hydroxyurea in Treating Patients With Acute Myeloid Leukemia or High-Risk Myelodysplasia conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. VNP40101M and Hydroxyurea in Treating Patients With Acute Myeloid Leukemia or High-Risk Myelodysplasia Clinical research trials and VNP40101M and Hydroxyurea in Treating Patients With Acute Myeloid Leukemia or High-Risk Myelodysplasia healthcare trials happen in a lot of of localities 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 measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as VNP40101M and Hydroxyurea in Treating Patients With Acute Myeloid Leukemia or High-Risk Myelodysplasia. VNP40101M and Hydroxyurea in Treating Patients With Acute Myeloid Leukemia or High-Risk Myelodysplasia Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a VNP40101M and Hydroxyurea in Treating Patients With Acute Myeloid Leukemia or High-Risk Myelodysplasia clinical trial. Human subjects often receive the most effective healthcare possible for their VNP40101M and Hydroxyurea in Treating Patients With Acute Myeloid Leukemia or High-Risk Myelodysplasia condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "V" Clinical Trials Conditions > VNP40101M and Hydroxyurea in Treating Patients With Acute Myeloid Leukemia or High-Risk Myelodysplasia  VNP40101M and Hydroxyurea in Treating Patients With Acute Myeloid Leukemia or High-Risk Myelodysplasia
VNP40101M and Hydroxyurea in Treating Patients With Acute Myeloid Leukemia or High-Risk Myelodysplasia
For Condition: atypical chronic myeloid leukemia,Myelodysplastic Syndromes,myelodysplastic and myeloproliferative disease,untreated adult acute myeloid leukemia,adult acute myeloid leukemia,Chronic Myelomonocytic Leukemia
Status: Recruiting
Sponsor(s): Vion Pharmaceuticals ,
Synopsis: RATIONALE: Drugs used in chemotherapy, such as VNP40101M and hydroxyurea, work in different ways to stop cancer cells from dividing so they stop growing or die. Hydroxyurea may help VNP40101M kill more cancer cells by making cancer cells more sensitive to the drug. PURPOSE: Phase II trial to study the effectiveness of combining VNP40101M with hydroxyurea in treating patients who have acute myeloid leukemia or high-riskmyelodysplasia.
Details: OBJECTIVES: - Determine the complete response rate in patients with acute myeloid leukemia or high-risk myelodysplasia treated with VNP40101M and hydroxyurea. - Determine the toxic effects of this regimen in these patients. OUTLINE: This is an open-label, multicenter study. Patients receive VNP40101M IV over 30 minutes once on day 1 and oral hydroxyurea every 12 hours on days 1-3 for a total of 6 doses (course 1). Four to five weeks after the first course, patients undergo bone marrow aspiration and biopsy. If the bone marrow is improved but contains residual leukemia, patients receive a second course of VNP40101M (at the same dose as in course 1 or at a lower dose) and hydroxyurea at the same dose as in course 1. If patients achieve partial response (PR), complete response (CR), or CRp after the first course, a consolidation course may be given comprising VNP40101M at a reduced dose in combination with hydroxyurea at the same dose as in course 1. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed for up to 2 years. PROJECTED ACCRUAL: A total of 21-45 patients will be accrued for this study within 6 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: - Acute myeloid leukemia - Less than 60 years of age and meets the following criteria: - In first relapse after first treatment-induced complete remission (CR) - Duration of first CR less than 12 months - No prior treatment for first relapse except hydroxyurea - 60 years of age and over and meets 1 of the following criteria: - In first relapse after first treatment-induced CR - No prior treatment for first relapse except hydroxyurea - No prior treatment with standard induction regimen with cytotoxic agents - High-risk myelodysplasia - No prior cytotoxic chemotherapy except hydroxyurea - High risk defined as International Prognostic Scoring System score 1.5, defined by cytogenetics, % marrow blasts, and lineage cytopenias PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Bilirubin 2.0 mg/dL - ALT or AST 5 times upper limit of normal - Chronic hepatitis allowed Renal - Creatinine 2.0 mg/dL Cardiovascular - No myocardial infarction within the past 3 months - No symptomatic coronary artery disease - No uncontrolled arrhythmias - No uncontrolled congestive heart failure - No other active heart disease Other - No uncontrolled active infection - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - See Disease Characteristics - Concurrent additional hydroxyurea (maximum dose of 5 g daily for up to 4 days) allowed between days 4 and 15 of each study course to control elevated blast levels Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified Other - Recovered from all prior therapy - At least 72 hours since prior anti-leukemic treatment with a non-cytotoxic agent - No concurrent disulfiram (Antabuse) - No other concurrent anticancer drugs except anagrelide within the first 15 days of study treatment to control elevated platelet counts - No other concurrent treatment for leukemia, except hydroxyurea used during study treatment - No other concurrent investigational drugs
Total Enrollment:
Location and Contact Information:
Overall Study Official:
FrancisGiles, Study Chair, M.D. Anderson Cancer Center
St. Francis Hospital and Medical Center *Recruiting*
Hartford, Connecticut, 06105
United States
Recruiting Syed Ali Bilgrami 860-714-4680
University of Texas - MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030-4095
United States
Recruiting Francis Giles 713-792-7305
Indiana Oncology Hematology Consultants *Recruiting*
Indianapolis, Indiana, 46202
United States
Recruiting Cathy Spears 317-833-1297
Additional Information:
Study ID Numbers: CDR0000365510; VION-CLI-033
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00083187
Other Atypical Chronic Myeloid Leukemia Studies:
1. Interleukin-2 in Treating Patients With Myelodysplastic Syndrome
2. PTK787/ZK 222584 in Treating Patients With Primary or Secondary Myelodysplastic Syndromes
3. FR901228 in Treating Patients With Myelodysplastic Syndrome, Acute Myeloid Leukemia, or Non-Hodgkin's Lymphoma
4. T-cell Depleted Bone Marrow and G-CSF Stimulated Peripheral Stem Cell Transplantation From Related Donors in Treating Patients With Leukemia, Lymphoblastic Lymphoma, Myelodysplastic Syndrome, or Aplastic Anemia
5. Chemotherapy Plus Bone Marrow Transplantation and Filgrastim in Treating Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome
Related Studies:
Other atypical chronic myeloid leukemia Clinical Trials
Other Indiana Clinical Trials
Other Indianapolis Clinical Trials
VNP40101M and Hydroxyurea in Treating Patients With Acute Myeloid Leukemia or High-Risk Myelodysplasia
|
|
|
|
|
|
|
|
