A Phase 2 interventional study of tipifarnib and etoposide in Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome, Adult Acute Megakaryoblastic Leukemia (M7) and Adult Acute Minimally Differentiated Myeloid Leukemia (M0), sponsored by National Cancer Institute (NCI). Completed at 5 sites in United States. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2014-10-09.
Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Treatment
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.
OBJECTIVES:
I. To compare the efficacy and toxicity of two schedules of tipifarnib plus etoposide as induction therapy in older patients with newly diagnosed, previously untreated acute myeloid leukemia.
II. To study mechanisms of leukemia cell resistance to tipifarnib in combination with etoposide.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive 600 mg of oral tipifarnib twice daily on days 1-14 and 100 mg of oral etoposide once daily on days 1-3 and 8-10.
ARM II: Patients receive 400 mg of oral tipifarnib twice daily on days 1-14 and 200 mg of oral etoposide once daily on days 1-3 and 8-10. (closed to accrual as of November 2008)
Treatment in both arms repeats every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 30 days and then every 90 days thereafter.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 84 is above the median of 38 across 4,247 interventional studies indexed under Leukemia.
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Criteria:
Inclusion Criteria:
Exclusion Criteria:
Patients receive 600 mg of oral tipifarnib twice daily on days 1-14 and 100 mg of oral etoposide once daily on days 1-3 and 8-10.
Drug: tipifarnib · Drug: etoposide
Patients receive 400 mg of oral tipifarnib twice daily on days 1-14 and 200 mg of oral etoposide once daily on days 1-3 and 8-10.
Drug: tipifarnib · Drug: etoposide
Given orally
Also known as: R115777, Zarnestra
Given orally
Also known as: EPEG, VP-16, VP-16-213
Complete Response
Bone marrow showing less than 5% myeloblasts with normal maturation of all cell lines, an ANC of at least 1000/mcL and a platelet count of 100,000 mcL, absence of blast in peripheral blood, absence of identifiable leukemic cells in the bone marrow, clearance of disease-associated cytogenetic abnormalities, and clearance of any previously existing extramedullary disease. A CR must be confirmed 4 to 6 weeks after the initial documentation. If possible, at least one bone marrow biopsy should be performed to confirm the CR.
Time frame: 6 months
January 2008 and December 2009,
| Milestone | Arm I | Arm II (Closed to Accrual as of November 2008) |
|---|---|---|
| Started | 63 | 21 |
| Completed | 62 | 21 |
| Not completed | 1 | 0 |
Bone marrow showing less than 5% myeloblasts with normal maturation of all cell lines, an ANC of at least 1000/mcL and a platelet count of 100,000 mcL, absence of blast in peripheral blood, absence of identifiable leukemic cells in the bone marrow, clearance of disease-associated cytogenetic abnormalities, and clearance of any previously existing extramedullary disease. A CR must be confirmed 4 to 6 weeks after the initial documentation. If possible, at least one bone marrow biopsy should be performed to confirm the CR.
| participants | Arm I | Arm II (Closed to Accrual as of November 2008) |
|---|---|---|
| Complete Response | 0 | 0 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm I | — | 5/63 (7.9%) | 18/63 (28.6%) |
| Arm II (Closed to Accrual as of November 2008) | — | 8/21 (38.1%) | 6/21 (28.6%) |
| Event | Arm I | Arm II (Closed to Accrual as of November 2008) |
|---|---|---|
| InfectionsInfections and infestations | 5/63 | 8/21 |
| non-hematologic toxicitiesGeneral disorders | 4/63 | 7/21 |
| Event | Arm I | Arm II (Closed to Accrual as of November 2008) |
|---|---|---|
| Dose reductionNervous system disorders | 18/63 | 6/21 |
| Age, Categorical(Participants) | Arm I | Arm II (Closed to Accrual as of November 2008) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 63 | 21 | 84 |
| Age, Continuous(years) | Arm I | Arm II (Closed to Accrual as of November 2008) | Total |
|---|---|---|---|
| Mean | 76 ± 20 | 78 ± 19 | 76 ± 20 |
| Sex: Female, Male(Participants) | Arm I | Arm II (Closed to Accrual as of November 2008) | Total |
|---|---|---|---|
| Female | 24 | 7 | 31 |
| Male | 39 | 14 | 53 |
| Region of Enrollment(participants) | Arm I | Arm II (Closed to Accrual as of November 2008) | Total |
|---|---|---|---|
| United States | 63 | 21 | 84 |
This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.
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