Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Tipifarnib in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	65 and over	NCI	JHOC-J0255 MSGCC-U5400, MSGCC-0116, NCI-1754, 1754, NCT00027872

Objectives

Primary

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

Secondary

1. Determine the progression-free and overall survival of patients treated with this drug.
2. Determine the duration of response in patients treated with this drug.
3. 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.
4. Determine the toxic effects of this drug in these patients.

Entry 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/mm³)



• No active CNS leukemia



• Ineligible for curative allogeneic stem cell transplantation

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

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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Judith Karp, MD, Protocol chair		Ph: 410-502-7726

Registry Information
Official Title		A Phase II Study Of Farnesyl Transferase Inhibitor R115777 (NSC# 702818) In Previously Untreated Poor-Risk Acute Myeloid Leukemia
Trial Start Date		2001-12-05
Trial Completion Date		2009-01-20
Registered in ClinicalTrials.gov		NCT00027872
Date Submitted to PDQ		2001-10-18
Information Last Verified		2004-08-31
NCI Grant/Contract Number		CA69854

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