Tipifarnib in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia

NCT00027872 | Completed Phase 2

• 4 other identifiers: NCI-2012-02980UMGCC 0116U01CA069854U01CA070095
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Complete remission (CR) rate

  CR rates will be calculated with 95% confidence intervals for each age group separately.

  Up to 8 years

Secondary Outcomes (4)

• Partial remission (PR) rate

  Up to 8 years

• Toxicity rates assessed using NCI CTCAE version 3.0

  Up to 8 years

• Duration of response

  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 survival

  From time of enrollment onto this study to the time of death, assessed up to 8 years

Study Arms (1)

Treatment (tipifarnib)

EXPERIMENTAL

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.

Drug: tipifarnib; Other: laboratory biomarker analysis

Interventions

tipifarnib DRUG

Given orally

Also known as: R115777, Zarnestra

Treatment (tipifarnib)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (tipifarnib)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287-8936, United States

Location

MeSH Terms

Conditions

Leukemia, Basophilic, Acute; Leukemia, Eosinophilic, Acute; Leukemia, Erythroblastic, Acute; Leukemia, Megakaryoblastic, Acute; Leukemia, Monocytic, Acute; Leukemia, Myeloid, Acute; Congenital Abnormalities; Leukemia, Myelomonocytic, Acute

Interventions

tipifarnib

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Myeloproliferative Disorders; Bone Marrow Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Judith Karp

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2001
• First Posted: January 27, 2003
• Study Start: October 1, 2001
• Primary Completion: July 1, 2007
• Study Completion: January 1, 2009
• Last Updated: March 25, 2013

Record last verified: 2013-03

Locations

US (1)