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

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Bortezomib; Tipifarnib

Criteria

Inclusion Criteria:

• 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

• No concurrent radiotherapy, chemotherapy, or immunotherapy

• No concurrent enzyme-inducing antiepileptic medications (e.g., phenytoin, phenobarbital, or carbamazepine)

• ECOG performance status 0-2

• LVEF >= 40%

• Pathologically confirmed diagnosis of 1 of the following:

• Acute myeloid leukemia

• Acute lymphoblastic leukemia

• Chronic myelogenous leukemia in blast phase