Tipifarnib and Etoposide in Treating Older Patients With Newly Diagnosed, Previously Untreated Acute Myeloid Leukemia

• Status: Completed
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This randomized phase II trial is studying the side effects and how well giving tipifarnib together with etoposide works in treating older patients with newly diagnosed, previously untreated 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Etoposide; Etoposide phosphate; Tipifarnib

Criteria

Criteria:

• Pathologically confirmed newly diagnosed acute myeloid leukemia (AML)

• Subtypes M0, M1, M2, M4-7 disease

• No newly diagnosed acute promyelocytic leukemia (M3)

• Any of the following diseases:

• De novo disease

• Secondary AML

• Myelodysplasia (MDS)-related AML (MDS/AML)

• Treatment-related AML

• Previously untreated disease

• Patients who have received prior hydroxyurea alone or non-cytotoxic therapies for MDS (e.g., thalidomide, interferon, cytokines, 5-azacytidine, or revlimid) will be eligible for this study

• Must be considered ineligible for traditional antileukemia chemotherapy

• No hyperleukocytosis with ≥ 30,000 blasts/uL or rapidly rising blast count with projected doubling time of =< 2 days

• Patients may receive hydroxyurea to lower blast count to < 30,000 blasts/uL up to 24 hours before beginning tipifarnib and etoposide

• No active CNS leukemia

• No prior tipifarnib or etoposide

• No concurrent radiotherapy, immunotherapy, or other chemotherapy

• No concurrent enzyme-inducing anticonvulsants (e.g., phenytoin, fosphenytoin, phenobarbital, primidone, carbamazepine, or oxcarbazepine)

• Patients may be changed to non-enzyme-inducing anticonvulsants and stabilized before starting study treatment

Inclusion Criteria:

• ECOG performance status 0-2

• Serum creatinine =< 2.0 mg/dL

• SGOT and SGPT =< 3 times upper limit of normal

• Bilirubin =< 2 mg/dL

Exclusion Criteria:

• Active, uncontrolled infection

• Patients with infection under active treatment and controlled with antimicrobials are eligible

• Presence of other life-threatening illnesses

• Patients with mental deficits and/or psychiatric history that preclude them from giving informed consent or from following protocol

• Allergies to imidazoles (e.g., clotrimazole, ketoconazole, miconazole, or econazole)