Leukemia Clinical Trial
Official title:
Phase II Study of Continuous Infusion Carboplatin and Topotecan in the Treamtment of Relapsed Acute Myelogenous Leukemia (AML)
Verified date | July 2016 |
Source | Alliance for Clinical Trials in Oncology |
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 tumor cells from dividing
so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining carboplatin and topotecan in
treating patients with relapsed acute myelogenous leukemia.
Status | Completed |
Enrollment | 38 |
Est. completion date | December 2006 |
Est. primary completion date | December 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 74 Years |
Eligibility |
DISEASE CHARACTERISTICS: Previously established diagnosis of acute myelogenous leukemia:
Failure to achieve a complete remission with initial induction regimen First relapse
within 1 year of initial complete remission Failure to achieve complete remission with one
or two courses of reinduction therapy at first relapse Second relapse after no more than
two different induction regimens Chemotherapy-related leukemia with unfavorable
cytogenetics No active CNS leukemia Not eligible for allogeneic bone marrow transplant
from related donor PATIENT CHARACTERISTICS: Age: 18 to 74 Performance status: ECOG 0-2 Life expectancy: At least 4 weeks Hematopoietic: Not specified Hepatic: Bilirubin no greater than upper limit of normal (ULN) (unless elevation due to AML) Renal: Creatinine no greater than 0.3 mg/dL above ULN Cardiovascular: No myocardial infarction within the past 3 months No congestive heart failure No poorly controlled cardiac arrhythmia Other: Not pregnant or nursing Fertile patients must use adequate contraception No psychosis No active systemic infections PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Recovered from the toxic effects of previous chemotherapy At least 3 days since hydroxyurea Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: No prior or concurrent aminoglycosides or amphotericin B within past 7 days |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Alliance for Clinical Trials in Oncology | National Cancer Institute (NCI) |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | overall survival | Up to 5 years | No |
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