Status:
COMPLETED
Tipifarnib and Etoposide in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Adult Acute Megakaryoblastic Leukemia (M7)
Adult Acute Minimally Differentiated Myeloid Leukemia (M0)
Eligibility:
All Genders
70+ years
Phase:
PHASE1
Brief Summary
This phase I trial is studying the side effects and best dose of tipifarnib and etoposide in treating older patients with newly diagnosed acute myeloid leukemia. Tipifarnib may stop the growth of canc...
Detailed Description
PRIMARY OBJECTIVES: I. To determine the feasibility, tolerability, and toxicities of administering a fixed dose of R115777 in combination with escalating doses of VP-16 in elderly adults ( = 70 years...
Eligibility Criteria
Inclusion
- Adults age with established, pathologically confirmed diagnoses of newly diagnosed AML, including de novo and secondary AMLs but excluding newly diagnosed acute progranulocytic leukemia (APL, M3), will be considered eligible for study
- ECOG performance status 0-2
- Patient must be able to give informed consent
- Serum creatinine =\< 2.0 mg/dl
- SGOT and SGPT =\< 5 x upper limit normal (ULN)
- Bilirubin =\< 2 mg/dl
- Disease-specific criteria:
- Newly diagnosed AML, subtypes M0,1,2,4-7 but excluding M3 (APL), including myelodysplasia (MDS)-related AML (MDS/AML) and treatment-related AML
- Patients who have received hydroxyurea alone or have received non-cytotoxic therapies previously for MDS (e.g., thalidomide, interferon, cytokines, 5-azacytidine) will be eligible for this trial
Exclusion
- Any previous treatment with R115777 or VP-16
- Patients receiving concomitant chemotherapy, radiation therapy or immunotherapy
- Hyperleukocytosis with \>= 30,000 blasts/uL or rapidly rising blast count with projected doubling time of =\< 2 days
- Acute progranulocytic leukemia (APL,M3)
- Active CNS leukemia
- Active, uncontrolled infection; patients with infection under active treatment and controlled with antibiotics are eligible
- Presence of other life-threatening illness
- Patients with mental deficits and/or psychiatric history that preclude them from giving informed consent or from following protocol
- Patients on enzyme-inducing anti-convulsants (e.g., phenytoin, fosphenytoin, phenobarbital, primidone, carbamazepine, oxcarbazepine); patients may be changed to non-enzyme inducing anti-convulsants and stabilized before starting study treatment
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00112853
Start Date
March 1 2005
Last Update
January 9 2013
Active Locations (1)
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1
Johns Hopkins University
Baltimore, Maryland, United States, 21287-8936