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Home > "S" Clinical Trials Conditions > STI571 Plus Combination Chemotherapy in Treating Patients With Chronic Myelogenous Leukemia or Acute Lymphocytic Leukemia  STI571 Plus Combination Chemotherapy in Treating Patients With Chronic Myelogenous Leukemia or Acute Lymphocytic Leukemia
STI571 Plus Combination Chemotherapy in Treating Patients With Chronic Myelogenous Leukemia or Acute Lymphocytic Leukemia
For Condition: blastic phase chronic myelogenous leukemia,relapsing chronic myelogenous leukemia,recurrent adult acute lymphoblastic leukemia
Status: Completed
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 combination chemotherapy plus STI571 in treating patients who have chronic myelogenous leukemia or acute lymphocytic leukemia.
Details: OBJECTIVES: - Determine the maximum tolerated dose of daunorubicin when combined with imatinib mesylate, vincristine, and prednisone in patients with lymphoid blastic phase chronic myelogenous leukemia or Philadelphia chromosome-positive acute lymphoblastic 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 in patients treated with this regimen. - Determine the duration of response of this patient population treated with this regimen. - Determine the survival of patients treated with this regimen. OUTLINE: This is a multicenter, dose-escalation study of daunorubicin. Patients who have not previously received imatinib mesylate receive oral imatinib mesylate 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 daunorubicin IV over 2-3 minutes on days 1-3, vincristine IV over 1 minute on days 1, 8, 15, and 22, and oral prednisone on days 1-28. 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 daunorubicin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are treated at the recommended phase II dose. 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: - One of the following diagnoses: - Chronic myelogenous leukemia in lymphoid blast crisis - Acute lymphoblastic leukemia (ALL) that is in first relapse or failed induction - No more than 1 prior course of induction chemotherapy - Philadelphia chromosome-positive (Ph+) by cytogenetic analysis OR bcr/abl translocation by fluorescent in situ hybridization - At least 30% blasts in bone marrow - 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: - 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) - ALT and AST less than 3 times ULN Renal: - Creatinine less than 2 times ULN Cardiovascular: - No New York Heart Association class III or IV cardiac 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: - See Disease Characteristics - At least 24 hours since prior hydroxyurea - At least 6 weeks since prior busulfan - Concurrent hydroxyurea or anagrelide for severe leukocytosis or thrombocytosis allowed Endocrine therapy: - Not specified Radiotherapy: - Not specified Surgery: - Not specified Other: - No prior therapy for blast crisis except hydroxyurea - No prior salvage or reinduction therapy for Ph+ ALL - At least 4 weeks since other prior investigational agents
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RonaldPaquette, Study Chair, Jonsson Comprehensive Cancer Center
Stanford University Medical Center
Stanford, California, 94305-5408
United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095
United States
Oregon Cancer Institute
Portland, Oregon, 97239
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Additional Information:
Study ID Numbers: CDR0000068444; UCLA-0011010,UCLA-NCI-4292,NCI-4292
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00015860
Other Relapsing Chronic Myelogenous Leukemia Studies:
1. Bevacizumab, Cytarabine, and Mitoxantrone on Treating Patients With Hematologic Cancers
2. BMS-214662 in Treating Patients With Acute Leukemia, Myelodysplastic Syndrome, or Chronic Myeloid Leukemia
3. 3-AP and High-Dose Cytarabine in Treating Patients With Advanced Hematologic Malignancies
4. STI571 Plus Cytarabine in Treating Patients With Chronic Myelogenous Leukemia
5. Chemotherapy in Treating Patients With Newly Diagnosed Acute or Chronic Myelogenous Leukemia or Myelodysplastic Syndrome
Related Studies:
Other relapsing chronic myelogenous leukemia Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
STI571 Plus Combination Chemotherapy in Treating Patients With Chronic Myelogenous Leukemia or Acute Lymphocytic Leukemia
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