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Phase I Study of Zarnestra (R115777.USA30) and Gleevec (Imatinib Mesylate) in Chronic Phase Chronic Myelogenous Leukemia (CML)


Phase 1
16 Years
N/A
Not Enrolling
Both
Leukemia, Myeloid, Chronic

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Trial Information

Phase I Study of Zarnestra (R115777.USA30) and Gleevec (Imatinib Mesylate) in Chronic Phase Chronic Myelogenous Leukemia (CML)


R115777 is a new drug that blocks the function of an enzyme that is important in making some
proteins work. One of the most important targets for this enzyme is a protein that can make
cells become cancer. Imatinib mesylate is a drug that blocks the function of the protein
that comes from the Philadelphia chromosome. The Philadelphia chromosome is an abnormality
in chromosomes 9 and 22 that changes blood cells into leukemia cells.

Before treatment starts, participants will have a physical exam, blood tests (About 3 tubes,
2 teaspoons each), and a bone marrow biopsy. The bone marrow will be removed with a large
needle.

Participants in this study will take imatinib mesylate by mouth every day for as long as
they stay on study, which means as long as it works. Participants will also take R115777
twice a day for 2 weeks. This will be repeated every 3 weeks. The amount of each of these
medications that participants take will depend on when they enter the study. The doses will
be slowly increased from participant to participant until the highest dose that does not
cause serious side effects is found.

Participants will be asked to visit their doctor for a physical exam and measurement of
vital signs. The frequency of doctor visits will vary depending on physical condition.
Blood tests (about 2 teaspoons each) will be done every week during the first 3 weeks of
treatment. Blood tests will then be done every 8-12 weeks for the length of the study, as
needed. The blood samples will be used for routine lab tests. A bone marrow sample will
also be taken to check and measure cells related to the disease every 3 months in the first
year and then every 6-12 months. Participants can stay on study for as long as the treatment
is considered to be beneficial. Participants will be taken off study if their disease gets
worse or intolerable side effects occur.

This is an investigational study. The FDA has authorized the use of imatinib mesylate for
patients with CML. It is the combination of imatinib mesylate and R115777 that is
experimental. R115777 has been authorized for investigational use only. A maximum of 30
patients will take part in this study. All will be enrolled at M. D. Anderson.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated doses (MTD)

Outcome Time Frame:

Every 3 months

Safety Issue:

No

Principal Investigator

Jorge E Cortes, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

ID02-169

NCT ID:

NCT00040105

Start Date:

October 2002

Completion Date:

March 2009

Related Keywords:

  • Leukemia, Myeloid, Chronic
  • Chronic Myelogenous Leukemia, Chronic Phase
  • R115777
  • Zarnestra
  • Tipifarnib
  • Imatinib Mesylate
  • Gleevec
  • Imatinib
  • STI571
  • NSC-716051
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Leukemia, Myeloid, Chronic-Phase

Name

Location
M.D. Anderson Cancer Center Houston, Texas  77030