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Home > "S" Clinical Trials Conditions > STI571 Plus Cytarabine in Treating Patients With Chronic Myelogenous Leukemia  STI571 Plus Cytarabine in Treating Patients With Chronic Myelogenous Leukemia
STI571 Plus Cytarabine in Treating Patients With Chronic Myelogenous Leukemia
For Condition: blastic phase chronic myelogenous leukemia,relapsing chronic myelogenous leukemia,Philadelphia chromosome positive chronic myelogenous leukemia
Status: Recruiting
Sponsor(s): Jonsson Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. STI571 may stop the growth of leukemia cells. Combining chemotherapy and STI571 may kill more cancer cells. PURPOSE: Phase I/II trial to study the effectiveness of combining STI571 and chemotherapy in treating patients who have chronic myelogenous leukemia.
Details: OBJECTIVES: - Determine the maximum tolerated dose of high-dose cytarabine when combined with imatinib mesylate in patients with blastic phase chronic myelogenous leukemia. - Determine the safety of this regimen in these patients. - Determine the pharmacokinetics of this regimen in these patients. - Determine the frequency of hematologic and cytogenetic responses, duration of response, and survival of patients treated with this regimen. OUTLINE: This is a multicenter, dose-escalation study of cytarabine. - Phase I: Patients who have not previously received imatinib mesylate receive oral imatinib mesylate daily on days 1-35. Patients who have previously received imatinib mesylate for at least 28 days receive oral imatinib mesylate on days 22-35. All patients receive cytarabine IV over 2 hours every 12 hours on days 29-32. Patients with more than 5% residual blasts in bone marrow on day 28 receive a second course in the absence of disease progression or unacceptable toxicity. - Cohorts of 3-6 patients receive escalating doses of cytarabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that which 2 of 6 patients experience dose-limiting toxicity. - Phase II: Additional patients are treated at the dose level preceding the MTD. Patients are followed monthly. PROJECTED ACCRUAL: A maximum of 46 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 chronic myelogenous leukemia in myeloid blast crisis - At least 30% blasts in bone marrow - Philadelphia chromosome positive by cytogenetic analysis OR - bcr/abl translocation by fluorescent in situ hybridization - Ineligible for or refused allogeneic stem cell transplantation - Not previously treated with imatinib mesylate OR currently receiving imatinib mesylate with stable disease on 2 bone marrow biopsies at least 2 weeks apart PATIENT CHARACTERISTICS: Age: - Phase I: - 18 to under 60 - Phase II: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - Not specified Hematopoietic: - See Disease Characteristics Hepatic: - Bilirubin less than 3 times upper limit of normal (ULN) - AST and ALT less than 3 times ULN Renal: - Creatinine less than 2 times ULN Cardiovascular: - No New York Heart Association class III or IV heart disease Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective barrier contraception during and for at least 2 weeks after study for female patients and at least 3 months after study for male patients PRIOR CONCURRENT THERAPY: Biologic therapy: - See Disease Characteristics - No prior allogeneic bone marrow or peripheral blood stem cell transplantation - At least 48 hours since prior interferon alfa Chemotherapy: - At least 24 hours since prior hydroxyurea - At least 6 weeks since prior busulfan - No other prior chemotherapy for blast crisis (except hydroxyurea) - Concurrent hydroxyurea or anagrelide for severe leukocytosis or thrombocytosis allowed Endocrine therapy: - Not specified Radiotherapy: - Not specified Surgery: - Not specified Other: - At least 4 weeks since prior investigational agents
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RonaldPaquette, Study Chair, Jonsson Comprehensive Cancer Center
Stanford University Medical Center *Recruiting*
Stanford, California, 94305-5408
United States
Recruiting Steven Coutre 650-723-4000
University of Texas - MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030-4009
United States
Recruiting Moshe Talpaz 713-792-3522
Oregon Cancer Institute *Recruiting*
Portland, Oregon, 97239
United States
Recruiting Brian Druker 503-494-1617
Jonsson Comprehensive Cancer Center, UCLA *Recruiting*
Los Angeles, California, 90095-1678
United States
Recruiting Ronald Paquette 310-825-5608
City of Hope Comprehensive Cancer Center *Recruiting*
Duarte, California, 91010-3000
United States
Recruiting Stephen Forman 626-359-8111
Additional Information:
Study ID Numbers: CDR0000068441; NCI-1870,UCLA-NCI-1870,UCLA-0011009
Study Start Date:
Record last reviewed: December 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00015834
Other Blastic Phase Chronic Myelogenous Leukemia Studies:
1. Bevacizumab, Idarubicin, and Cytarabine in Treating Patients With Blast Phase Chronic Myelogenous Leukemia
2. Chemotherapy in Treating Patients With Newly Diagnosed Acute or Chronic Myelogenous Leukemia or Myelodysplastic Syndrome
3. Homoharringtonine in Treating Patients With Chronic Myelogenous Leukemia
4. Flavopiridol and Imatinib Mesylate in Treating Patients With Hematologic Cancer
5. Fludarabine and Total-Body Irradiation Followed By Donor Peripheral Stem Cell Transplantation in Treating Patients With Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia That Has Responded to Treatment With Imatinib Mesylate
Related Studies:
Other blastic phase chronic myelogenous leukemia Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
STI571 Plus Cytarabine in Treating Patients With Chronic Myelogenous Leukemia
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