Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

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.

Further Study Information

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 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Judith E. Karp

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00027872
Information obtained from ClinicalTrials.gov on December 14, 2011

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