Status:
COMPLETED
Tipifarnib and Bortezomib in Treating Patients With Acute Leukemia or Chronic Myelogenous Leukemia in Blast Phase
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Adult Acute Basophilic Leukemia
Adult Acute Eosinophilic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 borte...
Detailed Description
PRIMARY OBJECTIVE: I. Determine the dose-limiting toxicity and maximum tolerated dose of tipifarnib and bortezomib in patients with relapsed or refractory acute myeloid leukemia, acute lymphoblastic ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00383474
Start Date
August 1 2006
End Date
June 1 2012
Last Update
April 15 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Moffitt Cancer Center
Tampa, Florida, United States, 33612