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Tipifarnib in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00027872
  Purpose

RATIONALE: Tipifarnib may stop the growth of cancer cells by blocking the enzymes necessary for their growth.

PURPOSE: Phase II trial to study the effectiveness of tipifarnib in treating older patients who have previously untreated acute myeloid leukemia.


Condition Intervention Phase
Leukemia
Drug: tipifarnib
Phase II

MedlinePlus related topics:   Cancer    Leukemia, Adult Acute    Leukemia, Adult Chronic   

Drug Information available for:   Tipifarnib   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label
Official Title:   A Phase II Study Of Farnesyl Transferase Inhibitor R115777 (NSC# 702818) In Previously Untreated Poor-Risk Acute Myeloid Leukemia

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   December 2001

Detailed Description:

OBJECTIVES:

Primary

  • Determine the complete response rate in older patients with previously untreated poor-risk acute myeloid leukemia treated with tipifarnib.

Secondary

  • Determine the progression-free and overall survival of patients treated with this drug.
  • Determine the duration of response in patients treated with this drug.
  • Determine the effect of this drug on the phosphorylation of mitogen-activated protein kinase (MAPK) and phosphatidyl inositol 3 kinase (PI3K) in leukemic cells in these patients.
  • Determine the toxic effects of this drug in these patients.

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.

  Eligibility
Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed newly diagnosed acute myeloid leukemia (AML)

    • At least 20% blasts in bone marrow
  • AML arising from myelodysplastic syndromes (MDS)
  • No acute promyelocytic leukemia (M3)
  • No hyperleukocytosis (at least 30,000 leukemic blasts/mm^3)
  • No active CNS leukemia
  • Ineligible for curative allogeneic stem cell transplantation

PATIENT CHARACTERISTICS:

Age:

  • 65 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • No disseminated intravascular coagulation (laboratory or clinical)

Hepatic:

  • Bilirubin normal
  • SGOT and SGPT no greater than 2.5 times normal

Renal:

  • Creatinine no greater than 1.5 times normal

Cardiovascular:

  • No severe congestive heart failure
  • No unstable angina

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No active systemic infection
  • No known allergy to imidazole drugs (e.g., ketoconazole, miconazole, econazole, terconazole, clotrimazole, fenticonazole, isoconazole, sulconazole, or tioconazole))
  • No physical or psychiatric condition that would preclude study compliance
  • No poorly controlled psychosis
  • No symptomatic neuropathy grade 2 or greater

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • See Disease Characteristics
  • No concurrent immunotherapy

Chemotherapy:

  • No prior chemotherapy for leukemia except hydroxyurea
  • No concurrent chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No concurrent radiotherapy

Surgery:

  • Not specified

Other:

  • At least 1 month since prior therapy for another malignancy
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00027872

Locations
United States, California
Stanford Cancer Center at Stanford University Medical Center    
      Stanford, California, United States, 94305-5750
United States, Georgia
Blood and Marrow Transplant Group of Georgia    
      Atlanta, Georgia, United States, 30342-4777
United States, Maryland
Greenebaum Cancer Center at University of Maryland Medical Center    
      Baltimore, Maryland, United States, 21201
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins    
      Baltimore, Maryland, United States, 21231
United States, New York
James P. Wilmot Cancer Center at University of Rochester Medical Center    
      Rochester, New York, United States, 14642
New York Weill Cornell Cancer Center at Cornell University    
      New York, New York, United States, 10021

Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)

Investigators
Study Chair:     Judith E. Karp, MD     Sidney Kimmel Comprehensive Cancer Center    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000069089, JHOC-J0255, MSGCC-U5400, MSGCC-0116, NCI-1754
First Received:   December 7, 2001
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00027872
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
untreated adult acute myeloid leukemia  
adult acute minimally differentiated myeloid leukemia (M0)  
adult acute myeloblastic leukemia without maturation (M1)  
adult acute myeloblastic leukemia with maturation (M2)  
adult acute myelomonocytic leukemia (M4)  
adult acute monocytic leukemia (M5b)
adult acute monoblastic leukemia (M5a)
adult acute erythroid leukemia (M6)
adult acute megakaryoblastic leukemia (M7)
adult acute myeloid leukemia with 11q23 (MLL) abnormalities

Study placed in the following topic categories:
Leukemia, Monocytic, Acute
Acute myelogenous leukemia
Acute myelomonocytic leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Di Guglielmo's syndrome
Leukemia, Myelomonocytic, Acute
Leukemia
Leukemia, Erythroblastic, Acute
Acute erythroblastic leukemia
Acute myeloid leukemia, adult
Congenital Abnormalities
Acute myelocytic leukemia
Acute monoblastic leukemia
Tipifarnib

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on December 03, 2008




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