Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00093418
Status:
COMPLETED
Last Update Posted:
2013-01-15
First Post:
2004-10-06
Brief Title:
S0432 Tipifarnib in Treating Older Patients With Acute Myeloid Leukemia
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Studies of Two Different Schedules and Two Different Doses of the Farnesyl Transferase Inhibitor R115777 Tipifarnib Zarnestra NSC-702818 for Previously Untreated Acute Myeloid Leukemia AML in Patients of Age 70 or Older
Status:
COMPLETED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This randomized phase II trial is studying 4 different tipifarnib regimens to compare how well they work in treating older patients with acute myeloid leukemia Tipifarnib may stop the growth of cancer cells by blocking the enzymes necessary for their growth
Detailed Description:
PRIMARY OBJECTIVES
I To test whether any or all of four different regimens of R115777 tipifarnib is sufficiently effective therapy for previously untreated acute myeloid leukemia AML in patients of age 70 or older to warrant Phase III investigation Additionally to allow increased access for patients to an agent that appears promising in this patient population
II To estimate the frequency and severity of toxicities of these regimens in this group of patients
III To investigate in a preliminary manner the relationship of cytogenetics with response to R115777 tipifarnib and assess whether karyotype represents a potential prognostic factor among older AML patients who are not candidates for chemotherapy and are treated with R1157777
IV To collect specimens for future correlations eg RAS and downstream targets to be identified at a later date
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 4 treatment arms
ARM I Patients receive oral tipifarnib twice daily on days 1-21 ARM II Patients receive oral tipifarnib twice daily on days 1-7 and 15-21 ARM III Patients receive tipifarnib as in arm I but at a lower dose ARM IV Patients receive tipifarnib as in arm II but at a lower dose
In all arms courses repeat every 28 days in the absence of unacceptable toxicity or disease progression Patients who achieve a complete remission CR receive up to 3 additional courses beyond CR Patients in CR who develop recurrent disease after the completion of therapy are eligible to receive tipifarnib again
Patients are followed every 3 months for 1 year every 6 months for 1 year and then annually for 3 years
I To test whether any or all of four different regimens of R115777 tipifarnib is sufficiently effective therapy for previously untreated acute myeloid leukemia AML in patients of age 70 or older to warrant Phase III investigation Additionally to allow increased access for patients to an agent that appears promising in this patient population
II To estimate the frequency and severity of toxicities of these regimens in this group of patients
III To investigate in a preliminary manner the relationship of cytogenetics with response to R115777 tipifarnib and assess whether karyotype represents a potential prognostic factor among older AML patients who are not candidates for chemotherapy and are treated with R1157777
IV To collect specimens for future correlations eg RAS and downstream targets to be identified at a later date
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 4 treatment arms
ARM I Patients receive oral tipifarnib twice daily on days 1-21 ARM II Patients receive oral tipifarnib twice daily on days 1-7 and 15-21 ARM III Patients receive tipifarnib as in arm I but at a lower dose ARM IV Patients receive tipifarnib as in arm II but at a lower dose
In all arms courses repeat every 28 days in the absence of unacceptable toxicity or disease progression Patients who achieve a complete remission CR receive up to 3 additional courses beyond CR Patients in CR who develop recurrent disease after the completion of therapy are eligible to receive tipifarnib again
Patients are followed every 3 months for 1 year every 6 months for 1 year and then annually for 3 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000387957 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU10CA032102 |
| S0432 | None | None | None |
| U10CA032102 | NIH | None | None |