Overview

Zarnestra and Gleevec in Chronic Phase Chronic Myelogenous Leukemia

Status:
Completed
Trial end date:
2009-03-01
Target enrollment:
0
Participant gender:
All
Summary
The goal of this clinical research study is to find the highest safe dose of the drugs ZarnestraTM (R115777) and Gleevec (imatinib mesylate) that can be given in combination for the treatment of chronic myelogenous leukemia (CML) in chronic phase. The effect of this combination on the leukemia will also be studied.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Treatments:
Imatinib Mesylate
Tipifarnib
Criteria
Inclusion Criteria:

- Patients 16 years or older with Philadelphia chromosome (Ph)- or BCR/ABL-positive CML
(as determined by cytogenetics, FISH, or PCR) are eligible if they are not candidates
for known regimens or protocol treatments of higher efficacy or priority. Patients
must be in the chronic phase of CML.

- Patients must have failed therapy with imatinib mesylate. Failure will be defined as:
1) patients who have failed to achieve or have lost a complete hematologic remission
at 3 months from the start of therapy with imatinib mesylate, or 2) patients who have
failed to achieve or have lost at least a minimal cytogenetic response after 6 months
of therapy with imatinib mesylate, or 3) patients who have failed to achieve or have
lost a major cytogenetic response after 12 months of therapy with imatinib mesylate

- Chronic phase will be defined by the following features: 1) blasts in peripheral blood
or bone marrow <10%, 2) basophils in PB or BM <20%, 3) platelets >100 x 10(9)/L, 4)
absence of clonal evolution

- Patients must sign an informed consent

- Performance status
- Patients must have adequate hepatic functions (bilirubin functions (creatinine
- WBC bring the WBC below this level. Hydroxyurea (or its equivalent) must be discontinued
24 hours before the start of therapy.

- Patients of childbearing potential should practice effective methods of contraception.

Exclusion Criteria:

- Patients under 16 years of age.

- Pregnant and nursing females will be excluded.