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Tipifarnib in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00027872
First Posted: January 27, 2003
Last Update Posted: March 25, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Cancer Institute (NCI)
December 7, 2001
January 27, 2003
March 25, 2013
October 2001
July 2007   (Final data collection date for primary outcome measure)
Complete remission (CR) rate [ Time Frame: Up to 8 years ]
CR rates will be calculated with 95% confidence intervals for each age group separately.
Not Provided
Complete list of historical versions of study NCT00027872 on ClinicalTrials.gov Archive Site
  • Partial remission (PR) rate [ Time Frame: Up to 8 years ]
    Will be estimated by observed proportions and 95% confidence intervals.
  • Toxicity rates assessed using NCI CTCAE version 3.0 [ Time Frame: Up to 8 years ]
    Will be estimated by observed proportions and 95% confidence intervals.
  • Duration of response [ Time Frame: From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 8 years ]
    Duration of response and survival will be summarized by the Kaplan-Meier estimate of the survival distribution.
  • Duration of survival [ Time Frame: From time of enrollment onto this study to the time of death, assessed up to 8 years ]
    Duration of response and survival will be summarized by the Kaplan-Meier estimate of the survival distribution.
Not Provided
Not Provided
Not Provided
 
Tipifarnib in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia
A Phase II Study of Farnesyl Transferase Inhibitor R115777 (Zarnestra) (R115777 ( Zarnestra), Tipifarnib, R115777, NSC #702818) in Elderly Patients With Previously Untreated Poor-Risk Acute Myeloid Leukemia
Tipifarnib may stop the growth of cancer cells by blocking the enzymes necessary for their growth. Phase II trial to study the effectiveness of tipifarnib in treating older patients who have previously untreated acute myeloid leukemia

PRIMARY OBJECTIVES:

I. To determine the complete response rate of R115777 (tipifarnib) in previously untreated acute myeloid leukemia (AML) in (a) elderly patients (age >= 75) and (b) patients (age >= 65) with AML preceded by myelodysplastic syndrome (MDS), using a chronic dosing schedule.

SECONDARY OBJECTIVES:

I. To determine progression-free and overall survival in patients with previously untreated AML treated with R115777, using a chronic dosing schedule.

II. To determine the duration of response in patients with previously untreated AML treated with R115777, using a chronic dosing schedule.

III. To determine the effect of R115777 on the phosphorylation of mitogen-activated protein kinase (MAPK) and phosphatidylinositol-4,5-bisphosphate 3-kinase, catalytic subunit alpha (PI3K) in leukemic cells.

IV. To determine the effect of R115777 on processing of the farnesylated protein HDJ-2.

V. To determine the toxicities of R115777 when given in a chronic dosing schedule.

OUTLINE: This is a multicenter study.

Patients receive oral tipifarnib twice daily on days 1-21. Patients with a complete or partial response, hematologic improvement, or stable disease continue treatment every 29-63 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response after the second course of therapy receive 2 additional courses of therapy.

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 125 patients will be accrued for this study within 11-17 months.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome
  • Adult Acute Basophilic Leukemia
  • Adult Acute Eosinophilic Leukemia
  • Adult Acute Erythroid Leukemia (M6)
  • Adult Acute Megakaryoblastic Leukemia (M7)
  • Adult Acute Minimally Differentiated Myeloid Leukemia (M0)
  • Adult Acute Monoblastic Leukemia (M5a)
  • Adult Acute Monoblastic Leukemia and Acute Monocytic Leukemia (M5)
  • Adult Acute Monocytic Leukemia (M5b)
  • Adult Acute Myeloblastic Leukemia With Maturation (M2)
  • Adult Acute Myeloblastic Leukemia Without Maturation (M1)
  • Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
  • Adult Acute Myeloid Leukemia With Del(5q)
  • Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
  • Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
  • Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
  • Adult Acute Myelomonocytic Leukemia (M4)
  • Adult Erythroleukemia (M6a)
  • Adult Pure Erythroid Leukemia (M6b)
  • Cellular Diagnosis, Adult Acute Myeloid Leukemia
  • Untreated Adult Acute Myeloid Leukemia
  • Drug: tipifarnib
    Given orally
    Other Names:
    • R115777
    • Zarnestra
  • Other: laboratory biomarker analysis
    Correlative studies
Experimental: Treatment (tipifarnib)
Patients receive oral tipifarnib twice daily on days 1-21. Patients with a complete or partial response, hematologic improvement, or stable disease continue treatment every 29-63 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response after the second course of therapy receive 2 additional courses of therapy.
Interventions:
  • Drug: tipifarnib
  • Other: laboratory biomarker analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
125
January 2009
July 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Pathologic confirmation of the diagnosis of AML (>= 20% marrow blasts)
  • ECOG performance status 0 or 1
  • Patients must be able to give informed consent
  • SGOT and SGPT =< 2.5 x normal limits (grade 1)
  • Serum creatinine =< 1.5 x normal limits (grade 1)
  • AML (any of the following):

    • Newly diagnosed AML in adults >= 75 years
    • Newly diagnosed AML arising from MDS in adults >= 65 years
  • Hyperleukocytosis with >= 30,000 leukemic blasts/uL

Exclusion Criteria:

  • Acute promyelocytic (FAB M3) subtype
  • Previously treated with chemotherapy for leukemia (except for hydroxyurea)
  • Disseminated intravascular coagulation (laboratory or clinical)
  • Active central nervous system leukemia
  • Concomitant radiation therapy, chemotherapy, or immunotherapy; previous therapy for another malignancy is permitted, provided that at least 1 month has occurred since patient received any of these treatments
  • Intrinsic impaired organ function (as stated above)
  • Symptomatic neuropathy (grade 2 or worse)
  • Known allergy to imidazole drugs, such as ketoconazole, miconazole, econazole, teconazole, clotrimazole, fenticonazole, isoconazole, sulconazole, or ticonazole
  • Physical or psychiatric conditions that in the estimation of the principal investigator (PI) or designee place the patient at high risk of toxicity or non-compliance, e.g. severe congestive heart failure (CHF), unstable angina, or poorly controlled psychosis
Sexes Eligible for Study: All
65 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00027872
NCI-2012-02980
UMGCC 0116
U01CA069854 ( U.S. NIH Grant/Contract )
U01CA070095 ( U.S. NIH Grant/Contract )
Not Provided
Not Provided
Not Provided
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Not Provided
Principal Investigator: Judith Karp Johns Hopkins University
National Cancer Institute (NCI)
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP