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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 Relapsing Chronic Myelogenous Leukemia Studies:
1. Homoharringtonine Compared With Hydroxyurea for Chronic Myelogenous Leukemia That Has Not Responded to Interferon alfa
2. Interferon-alfa With or Without Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Newly Diagnosed Chronic Myelogenous Leukemia
3. Imatinib Mesylate and Interferon Alfa in Treating Patients With Chronic Myelogenous Leukemia
4. Imatinib Mesylate and Cytarabine in Treating Patients With Newly Diagnosed Chronic Myeloid Leukemia
5. Vaccine Therapy in Treating Patients With Chronic Myelogenous Leukemia
Related Studies:
Other relapsing 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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