Recurrent Adult Acute Myeloid Leukemia Clinical Trial
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
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
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 (e.g. 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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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