Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities Clinical Trial
Official title:
A Phase I Trial of Oral Etoposide in Combination With the Farnesyltransferase Inhibitor R115777 (ZARNESTRA, Tipifarnib, NSC #702818, IND #58,359) in Elderly Adults With Newly Diagnosed Acute Myelogenous Leukemia (AML)
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 cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as etoposide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving tipifarnib together with etoposide may kill more cancer cells
Status | Completed |
Enrollment | 100 |
Est. completion date | |
Est. primary completion date | May 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 70 Years and older |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins University | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of patients who experience dose limiting toxicities (DLT), based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0 | Up to 28 days | Yes | |
Primary | Clinical response in terms of optimal dose combination for further study | A response surface will be constructed using a flexible two dimensional polynomial. | Up to 4 years | No |
Primary | Clinical tolerance in terms of additive or synergistic non-hematologic toxicities grade 2 or greater | A response surface will be constructed using a flexible two dimensional polynomial. | Up to 4 years | Yes |
Primary | Surrogates of response in terms of cell cycle progression and apoptosis, deoxyribonucleic acid (DNA) damage, and results of in vitro model studies (using pre-post assessments). | A response surface will be constructed using a flexible two dimensional polynomial. | Up to day 63 | No |
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