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VNP40101M and Cytarabine in Treating Patients With Hematologic Malignancies Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about VNP40101M and Cytarabine in Treating Patients With Hematologic Malignancies conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. VNP40101M and Cytarabine in Treating Patients With Hematologic Malignancies Clinical research trials and VNP40101M and Cytarabine in Treating Patients With Hematologic Malignancies medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as VNP40101M and Cytarabine in Treating Patients With Hematologic Malignancies. VNP40101M and Cytarabine in Treating Patients With Hematologic Malignancies Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a VNP40101M and Cytarabine in Treating Patients With Hematologic Malignancies clinical trial. Subjects often receive the most expert healthcare possible for their VNP40101M and Cytarabine in Treating Patients With Hematologic Malignancies condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "V" Clinical Trials Conditions > VNP40101M and Cytarabine in Treating Patients With Hematologic Malignancies  VNP40101M and Cytarabine in Treating Patients With Hematologic Malignancies
VNP40101M and Cytarabine in Treating Patients With Hematologic Malignancies
For Condition: relapsing chronic myelogenous leukemia,blastic phase chronic myelogenous leukemia,Chronic Myelomonocytic Leukemia,adult acute myeloid leukemia,Myelodysplastic Syndromes,adult acute lymphoblastic leukemia
Status: Recruiting
Sponsor(s): Vion Pharmaceuticals , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy, such as VNP40101M and cytarabine, use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase I trial to study the effectiveness of combining VNP40101M with cytarabine in treating patients who have hematologic malignancies, including myelodysplastic syndrome or relapsed, refractory, or untreated leukemia.
Details: OBJECTIVES: - Determine the maximum tolerated dose of VP40101M when administered with cytarabine in patients with hematologic malignancies. - Determine the toxic effects of this regimen in these patients. OUTLINE: This is an open-label, dose-escalation study of VNP40101M. Patients receive cytarabine IV over 24 hours on days 1-4 for patients under 65 years of age OR on days 1-3 for patients 65 years of age and over. Patients also receive VNP40101M IV over 15-60 minutes on day 2. Treatment repeats every 4 weeks for up to 3 courses (in patients with responding disease) in the absence of disease progression or unacceptable toxicity. Patients with a continued response may receive additional courses at the discretion of the investigator. Cohorts of 3-6 patients receive escalating doses of VNP40101M 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. Up to 10 patients may receive treatment at the MTD. PROJECTED ACCRUAL: Approximately 25 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: - Diagnosis of leukemia or myelodysplastic syndromes (MDS) meeting criteria for 1 of the following: - Relapsed or refractory leukemia for which there is no standard therapy anticipated to result in a durable remission - Acute myeloid leukemia - Acute lymphocytic leukemia - Chronic myelogenous leukemia - In blast crisis - Untreated leukemia and standard therapy is refused - Any of the following poor-risk MDS: - Refractory anemia with excess blasts (RAEB) - RAEB in transformation - Chronic myelomonocytic leukemia - CNS leukemia allowed PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - ALT or AST no greater than 3 times ULN - Chronic hepatitis allowed Renal - Creatinine no greater than 2.0 mg/dL Cardiovascular - No active heart disease - No myocardial infarction within the past 3 months - No symptomatic coronary artery disease - No arrhythmias uncontrolled by medication - No uncontrolled congestive heart failure Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No persistent chronic toxic effects from prior chemotherapy greater than grade 1 - No uncontrolled active infection - Infections under control and under active treatment with antibiotics allowed PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - At least 48 hours since prior hydroxyurea Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified Other - At least 2 weeks since prior myelosuppressive cytotoxic agents (in the absence of rapidly progressing disease) - No other concurrent standard or investigational treatment for leukemia - No concurrent disulfiram
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MarioSznol, Study Chair, Vion Pharmaceuticals
University of Texas - MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030-4095
United States
Recruiting Francis Giles 713-792-7305
Additional Information:
Study ID Numbers: CDR0000334879; VION-CLI-034,MDA-2003-0326
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00070538
Other Adult Acute Myeloid Leukemia Studies:
1. PS-341 in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Chronic Myeloid Leukemia in Blast Phase, or Myelodysplastic Syndrome
2. FR901228 in Treating Children with Refractory or Recurrent Solid Tumors or Leukemia
3. Flavopiridol and Imatinib Mesylate in Treating Patients With Hematologic Cancer
4. Sargramostim Following Allogeneic Bone Marrow Transplantation in Treating Patients With Chronic Myelogenous Leukemia
5. Homoharringtonine in Treating Patients With Chronic Myelogenous Leukemia
Related Studies:
Other adult acute myeloid leukemia Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
VNP40101M and Cytarabine in Treating Patients With Hematologic Malignancies
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