Leukemia Clinical Trial
Official title:
Phase II Trial of Arsenic Trioxide in Relapsed and Refractory Acute Myeloid Leukemia, Secondary Leukemia, and/or Newly-Diagnosed Patients Greater Than or Equal to 65 Years Old
Verified date | June 2012 |
Source | Northwestern University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients
who have acute myeloid leukemia.
Status | Completed |
Enrollment | 11 |
Est. completion date | July 2002 |
Est. primary completion date | July 2002 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 16 Years and older |
Eligibility |
DISEASE CHARACTERISTICS: Documented acute myelogenous leukemia (AML) including secondary
AML and biphenotypic leukemia Secondary AML may be either chemotherapy induced or evolving
from a myelodysplastic syndrome Bone marrow evidence of AML must include the following:
Cellularity of 20% or greater Minimum of 20% leukemic cells Signs of bone marrow failure
such as: Anemia (hemoglobin less than 12.0 g/dL) Granulocytopenia (granulocyte count less
than 1,500/mm3) Thrombocytopenia (platelet count less than 100,000/mm3) Must not be any of
the following: Acute lymphoblastic leukemia Blastic phase of chronic myelogenous leukemia
Acute promyelocytic leukemia (M3) Prior induction therapy using any conventional induction
chemotherapy regimen required In first or second relapse after successful induction
therapy OR Failed 1 attempt at reinduction relapse OR Refractory to at least 1 prior
induction therapy No prior induction therapy allowed in secondary AML or in newly
diagnosed AML in patients at least 65 years old PATIENT CHARACTERISTICS: Age: 16 and over Performance status: ECOG 0-2 Life expectancy: At least 6 weeks Hematopoietic: See Disease Characteristics No evidence of being platelet transfusion refractory WBC no greater than 20,000/mm3 (leukapheresis, hydroxyurea, or both allowed) Hepatic: Bilirubin no greater than 2.0 mg/dL unless leukemic infiltration to liver SGOT or SGPT less than 2 times upper limit of normal Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No evidence of symptomatic coronary atherosclerotic heart disease Other: Not pregnant Negative pregnancy test Fertile patients must use effective contraception No active infection and afebrile Afebrile, stable, and completing antibiotics allowed Febrile not from infection but from blood products allowed PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent bone marrow transplantation Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No concurrent radiotherapy Surgery: Not specified Other: No other concurrent antileukemic agents |
Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Robert H. Lurie Comprehensive Cancer Center, Northwestern University | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Northwestern University | National Cancer Institute (NCI) |
United States,
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