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Flavopiridol and Imatinib Mesylate in Treating Patients With Hematologic Cancer 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 Flavopiridol and Imatinib Mesylate in Treating Patients With Hematologic Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Flavopiridol and Imatinib Mesylate in Treating Patients With Hematologic Cancer Clinical research trials and Flavopiridol and Imatinib Mesylate in Treating Patients With Hematologic Cancer 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 Flavopiridol and Imatinib Mesylate in Treating Patients With Hematologic Cancer. Flavopiridol and Imatinib Mesylate in Treating Patients With Hematologic Cancer 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 Flavopiridol and Imatinib Mesylate in Treating Patients With Hematologic Cancer clinical trial. Human subjects often receive the most effective healthcare possible for their Flavopiridol and Imatinib Mesylate in Treating Patients With Hematologic Cancer 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.
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Home > "F" Clinical Trials Conditions > Flavopiridol and Imatinib Mesylate in Treating Patients With Hematologic Cancer  Flavopiridol and Imatinib Mesylate in Treating Patients With Hematologic Cancer
Flavopiridol and Imatinib Mesylate in Treating Patients With Hematologic Cancer
For Condition: accelerated phase chronic myelogenous leukemia,adult acute lymphoblastic leukemia,adult acute myeloid leukemia,relapsing chronic myelogenous leukemia,chronic phase chronic myelogenous leukemia,blastic phase chronic myelogenous leukemia
Status: Recruiting
Sponsor(s): Massey Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Drugs used in chemotherapy such as flavopiridol use different ways to stop cancer cells from dividing so they stop growing or die. Combining imatinib mesylate with flavopiridol may kill more cancer cells. PURPOSE: Phase I trial to study the effectiveness of combining flavopiridol with imatinib mesylate in treating patients who have hematologic cancer.
Details: OBJECTIVES: - Determine the maximum tolerated dose and recommended phase II dose of flavopiridol and imatinib mesylate in patients with Bcr/Abl+ hematological malignancies. - Determine the toxic effects of this regimen in these patients. - Determine the disease-related effects of this regimen in these patients. - Determine the pharmacokinetics and pharmacodynamics of this regimen in these patients. - Correlate response to this regimen with mechanisms of imatinib mesylate resistance in patients previously treated with imatinib mesylate. OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to percentage of blasts in the peripheral blood and bone marrow (less than 15% vs at least 15%). Patients receive oral imatinib mesylate daily and flavopiridol IV over 1 hour on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of imatinib mesylate and flavopiridol 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. PROJECTED ACCRUAL: A total of 6-80 patients will be accrued for this study within 1 year.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of 1 of the following: - Chronic or accelerated phase chronic myelogenous leukemia (CML) with 1 of the following: - Hematologic progression during prior imatinib mesylate treatment - Less than a complete hematologic response after at least 3 months of prior imatinib mesylate treatment - Less than a major cytogenetic response after at least 6 months of imatinib mesylate treatment (cytogenetic response documented by karyotype or fluorescence in situ hybridization [FISH]) - Blastic phase CML* - Acute lymphoblastic leukemia* - Acute myeloid leukemia* NOTE: *Patients may be enrolled at presentation, in remission, or upon relapse - Bcr/Abl+ in bone marrow confirmed by karyotype or FISH - No known CNS malignancy PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - Not specified Hematopoietic - See Disease Characteristics Hepatic - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - AST and ALT no greater than 2.5 times ULN (5 times ULN if hepatic involvement suspected [stratum 2 only]) Renal - Creatinine no greater than 2 times ULN Cardiovascular - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Other - Not pregnant or nursing - Fertile patients must use effective contraception during and for 3 months after study participation - No prior allergic reaction attributed to compounds of similar chemical or biological composition to study agents - No other concurrent uncontrolled medical illness - No ongoing or active infection - No psychiatric illness or social situation that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent filgrastim (G-CSF), sargramostim (GM-CSF), or interleukin-2 during the first course of study therapy unless clinically indicated for management of febrile neutropenia or thrombocytopenia - Concurrent epoetin alfa allowed if started before study entry and it remains clinically appropriate Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified Other - See Disease Characteristics - Recovered from all prior therapy - No other concurrent investigational or anticancer agents - No concurrent combination antiretroviral therapy for HIV-positive patients
Total Enrollment:
Location and Contact Information:
Overall Study Official:
StevenGrant, Study Chair, Massey Cancer Center
Massey Cancer Center at Virginia Commonwealth University *Recruiting*
Richmond, Virginia, 23298
United States
Recruiting John Roberts 804-628-1940
Abramson Cancer Center at University of Pennsylvania Medical Center *Recruiting*
Philadelphia, Pennsylvania, 19104-4283
United States
Recruiting Selina Luger 215-662-6348
Ireland Cancer Center *Recruiting*
Cleveland, Ohio, 44106
United States
Recruiting Omer Koc 216-368-1176
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins *Recruiting*
Baltimore, Maryland, 21231
United States
Recruiting Judith Karp 410-502-5399
Additional Information:
Study ID Numbers: CDR0000310175; MCV-NCI-6013,NCI-6013,CWRU-030323,MCV-VCU-1902
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00064285
Other Blastic Phase Chronic Myelogenous Leukemia Studies:
1. Imatinib Mesylate and Decitabine in Treating Patients With Chronic Myelogenous Leukemia
2. Combination Chemotherapy Followed By Peripheral Stem Cell Transplantation or Isotretinoin in Treating Patients With Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Acute Lymphocytic Leukemia
3. Bortezomib in Treating Young Patients With Refractory or Recurrent Leukemia
4. Combination Chemotherapy in Treating Patients With Chronic Myelogenous Leukemia or Recurrent Acute Leukemia
5. Comparison of Two Combination Chemotherapy Regimens in Treating Adults With Previously Untreated Leukemia or Lymphoma
Related Studies:
Other blastic phase chronic myelogenous leukemia Clinical Trials
Other Ohio Clinical Trials
Other Cleveland Clinical Trials
Flavopiridol and Imatinib Mesylate in Treating Patients With Hematologic Cancer
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