Leukemia Clinical Trial
Official title:
Irinotecan And Cytarabine In Refractory or Relapsed Acute Myeloid Leukemia And In Chronic Myelogenous Leukemia In Myeloid Blast Transformation: Efficacy And In Vitro Correlates
Verified date | March 2011 |
Source | Roswell Park Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
RATIONALE: Drugs used in chemotherapy use 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 I trial to study the effectiveness of combining irinotecan with cytarabine in
treating patients who have refractory or recurrent acute myeloid leukemia or chronic
myelogenous leukemia.
Status | Completed |
Enrollment | 0 |
Est. completion date | March 2003 |
Est. primary completion date | February 2003 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 15 Years and older |
Eligibility |
DISEASE CHARACTERISTICS: - Histologically confirmed acute myeloid leukemia (M0-M7) - De novo or secondary disease - Previously treated and refractory to prior therapy (which has included high-dose cytarabine and an anthracycline) - Antecedent hematologic disorders allowed OR - Histologically confirmed Philadelphia chromosome-positive chronic myelogenous leukemia in myeloid blast transformation - Treated or untreated - Blast transformation defined by at least 20% blasts in marrow and/or blood - Myeloid lineage defined by immunophenotyping PATIENT CHARACTERISTICS: Age - 15 and over Performance status - 0-3 Life expectancy - At least 4 weeks Hematopoietic - See Disease Characteristics Hepatic - Bilirubin less than 2 times upper limit of normal (ULN) - SGOT less than 2 times ULN Renal - Creatinine less than 1.5 times ULN Other - Not pregnant or nursing - Negative pregnancy test - No other concurrent serious medical or psychiatric illness that would preclude study consent PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - See Disease Characteristics - Prior chemotherapy for an antecedent malignancy or other medical condition allowed Endocrine therapy - Not specified Radiotherapy - Prior radiotherapy for an antecedent malignancy or other medical condition allowed Surgery - Not specified |
Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Roswell Park Cancer Institute | Buffalo | New York |
Lead Sponsor | Collaborator |
---|---|
Roswell Park Cancer Institute | National Cancer Institute (NCI) |
United States,
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