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Home > "F" Clinical Trials Conditions > Flavopiridol, Cytarabine, and Mitoxantrone in Treating Patients With Acute Leukemia  Flavopiridol, Cytarabine, and Mitoxantrone in Treating Patients With Acute Leukemia
Flavopiridol, Cytarabine, and Mitoxantrone in Treating Patients With Acute Leukemia
For Condition: untreated adult acute lymphoblastic leukemia,recurrent adult acute myeloid leukemia,secondary acute myeloid leukemia,untreated adult acute myeloid leukemia,recurrent adult acute lymphoblastic leukemia
Status: Recruiting
Sponsor(s): Sidney Kimmel Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy work in 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 II trial to study the effectiveness of combining flavopiridol and cytarabine with mitoxantrone in treating patients who have acute leukemia.
Details: OBJECTIVES: - Determine the toxic effects of escalating doses of flavopiridol administered with cytarabine and mitoxantrone in patients with poor-risk acute leukemias. - Determine whether this treatment induces clinical responses in these patients. - Determine whether flavopiridol is directly cytotoxic to leukemic blasts in these patients. - Determine whether flavopiridol can recruit and synchronize residual leukemic blasts to proliferate in these patients. OUTLINE: This is a dose-escalation study of flavopiridol. (Phase I closed to accrual effective10/24/2003). Patients receive flavopiridol IV over 1 hour on days 1-3 and cytarabine IV continuously on days 6-9 followed by mitoxantrone IV over 30-150 minutes on day 9. Patients achieving a partial or complete response after the first course of therapy may receive an additional course of therapy beginning 35 ± 7 days after blood count recovery. Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. (Phase I closed to accrual effective 10/24/2003). Once the MTD is reached, additional patients are accrued to receive flavopiridol at the recommended phase II dose. PROJECTED ACCRUAL: Approximately 25-35 patients will be accrued for phase I of the study (phase I closed to accrual effective 10/24/2003). A total of 53 patients will be accrued for phase II of the study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - One of the following histologically confirmed poor-risk acute leukemias: - Acute myelogenous leukemia (AML) - AML arising from myelodysplastic syndromes (MDS) - Secondary AML - Relapsed or refractory AML, including primary induction failure - Acute lymphoblastic leukemia (ALL) - Relapsed or refractory ALL, including primary induction failure - No hyperleukocytosis with at least 50,000 leukemic blasts/mm^3 - Failure of primary induction therapy or relapse after achieving complete remission allowed if completed no more than 3 prior courses of induction/reinduction therapy - No active CNS leukemia PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - Not specified Hematopoietic: - See Disease Characteristics - No disseminated intravascular coagulation Hepatic: - AST and ALT no greater than 2.5 times normal - Alkaline phosphatase no greater than 2.5 times normal - Bilirubin no greater than 1.5 times normal Renal: - Creatinine no greater than 2.0 mg/dL Cardiovascular: - No intrinsic impaired cardiac function including the following: - Myocardial infarction within the past 3 months - History of congestive heart disease or arrhythmia (regardless of time, severity, or resolution) - Cardiomyopathy - Class III or IV congestive heart failure - LVEF at least 45% by MUGA or echocardiogram Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No active uncontrolled infection PRIOR CONCURRENT THERAPY: Biologic therapy: - Prior autologous or allogeneic stem cell transplantation allowed provided at least 4 weeks since treatment and no presence of active graft-vs-host disease - At least 4 days since prior hematopoietic growth factors (e.g., epoetin alfa, filgrastim [G-CSF], sargramostim [GM-CSF], interleukin-3, or interleukin-11) - Prior interferon allowed - No concurrent immunotherapy Chemotherapy: - See Disease Characteristics - At least 4 weeks since prior intensive chemotherapy except non-aplasia-producing agents (e.g., hydroxyurea or 6-methylpurine) and recovered - No other concurrent chemotherapy Endocrine therapy: - Not specified Radiotherapy: - No concurrent radiotherapy Surgery: - Not specified Other: - Prior thalidomide or imatinib mesylate allowed - No other concurrent investigational or commercially-available antitumor therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JudithKarp, Study Chair, Sidney Kimmel Cancer Center
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins *Recruiting*
Baltimore, Maryland, 21231
United States
Recruiting Judith Karp 410-502-7726
Mayo Clinic Cancer Center *Recruiting*
Rochester, Minnesota, 55905
United States
Recruiting Keith Bible 507-284-7070
Additional Information:
Study ID Numbers: CDR0000068582; MSGCC-0052,JHOC-J0254,NCI-3170
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00016016
Other Untreated Adult Acute Lymphoblastic Leukemia Studies:
1. Carboplatin Plus Topotecan in Treating Patients With Relapsed Acute Myelogenous Leukemia
2. Fludarabine and Busulfan Followed by Allogeneic Stem Cell Transplantation in Treating Older Patients With Acute Myeloid Leukemia in First Complete Remission
3. Combination Chemotherapy With or Without G-CSF in Treating Older Patients With Acute Myeloid Leukemia
4. Amifostine and High-Dose Combination Chemotherapy in Treating Patients With Acute Myeloid Leukemia or Chronic Myelogenous Leukemia
5. High Dose Chemotherapy, Peripheral Stem Cell Transplantation, and Interleukin-2 in Treating Patients With Acute Myeloid Leukemia
Related Studies:
Other untreated adult acute lymphoblastic leukemia Clinical Trials
Other Maryland Clinical Trials
Other Baltimore Clinical Trials
Flavopiridol, Cytarabine, and Mitoxantrone in Treating Patients With Acute Leukemia
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