Tipifarnib and Bortezomib in Treating Patients With Acute Leukemia or Chronic Myelogenous Leukemia in Blast Phase

Completed · Phase 1

Conditions studied: Adult Acute Basophilic Leukemia, Adult Acute Eosinophilic Leukemia, Adult Acute Megakaryoblastic Leukemia, Adult Acute Monoblastic Leukemia, Adult Acute Monocytic Leukemia, Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11, Adult Acute Myeloid Leukemia With Maturation, Adult Acute Myeloid Leukemia With Minimal Differentiation, Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11, Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); RUNX1-RUNX1T1, Adult Acute Myeloid Leukemia With t(9;11)(p22;q23); MLLT3-MLL, Adult Acute Myeloid Leukemia Without Maturation, Adult Acute Myelomonocytic Leukemia, Adult Erythroleukemia, Adult Pure Erythroid Leukemia, Blastic Phase, Recurrent Adult Acute Lymphoblastic Leukemia, Recurrent Adult Acute Myeloid Leukemia, Recurrent Disease, Untreated Adult Acute Lymphoblastic Leukemia, Untreated Adult Acute Myeloid Leukemia

In brief

This phase I trial is studying the side effects and best dose of tipifarnib and bortezomib in treating patients with acute leukemia or chronic myelogenous leukemia in blast phase. Tipifarnib and bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving tipifarnib together with bortezomib may kill more cancer cells.

Key facts

Study ID

NCT00383474

Run by

National Cancer Institute (NCI)

People needed

35

Starts

2006-08-01

Expected to finish

2012-06-01

Last updated by the study team

2015-04-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Meets 1 of the following disease-specific criteria:
• Relapsed disease after =< 2 prior chemotherapy regimens (consolidation therapy excluded)
• Primary-induction failure
• Previously untreated and deemed unfit for or refusing cytotoxic chemotherapy
• No hyperleukocytosis (leukemic blasts >= 30,000/mm\^3)
• No acute promyelocytic leukemia (M3)
• No active CNS leukemia
• SGOT and SGPT =< 2 times upper limit of normal (ULN)
• Bilirubin normal
• Creatinine =< 1.5 times ULN
• No uncontrolled hypertension, congestive heart failure, angina pectoris, or ventricular dysrhythmias
• Not pregnant or nursing
• Negative pregnancy test
• No uncontrolled disseminated intravascular coagulation
• Fertile patients must use effective contraception
• Hormonal contraception must have been initiated ≥ 1 month prior to study entry
• No active graft-vs-host disease
• No active uncontrolled infection
• No intrinsic impaired organ function
• No known allergy to imidazole drugs
• No neuropathy >= grade 1
• No known hypersensitivity to bortezomib, tipifarnib, boron, or mannitol
• No physical or psychiatric conditions that would preclude study participation, including poorly controlled psychosis
• At least 48 hours since prior hydroxyurea
• No prior tipifarnib, bortezomib, or investigational proteasomal inhibitors

Where it is running

• Moffitt Cancer Center — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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