Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

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. ;


Study Design

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


Related Conditions & MeSH terms


NCT number NCT00040105
Study type Interventional
Source M.D. Anderson Cancer Center
Contact
Status Completed
Phase Phase 1
Start date October 2002
Completion date March 2009

See also
  Status Clinical Trial Phase
Terminated NCT00393380 - Study of Parathyroid Hormone Following Sequential Cord Blood Transplantation From an Unrelated Donor Phase 2
Completed NCT00186342 - Sibling and Unrelated Donor Hematopoietic Cell Transplant in Hematologic Malignancies N/A
Completed NCT00759837 - Study Evaluating The Pharmacokinetics (PK) And Safety Of Bosutinib In Subjects With Liver Disease And In Healthy Subjects Phase 1
Completed NCT00538109 - An Open-Label, Multicenter, Expanded Access Study of Oral AMN 107 in Adult Patients With Imatinib (Glivec®/Gleevec®_ - Resistant or Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase N/A
Terminated NCT00176930 - Stem Cell Transplant for Hematological Malignancy N/A
Recruiting NCT01015742 - Unrelated Double Umbilical Cord Blood Units Transplantation Phase 2/Phase 3
Completed NCT00406393 - Sirolimus/Tacrolimus Versus Tacrolimus/Methotrexate for Preventing Graft-Versus-Host Disease (GVHD) (BMT CTN 0402) Phase 3
Completed NCT00246662 - Safety Assessment of Two Schedules of Intravenous Infusions of SNS-595 for the Treatment of Hematologic Malignancies Phase 1
Completed NCT00264160 - Efficacy and Safety of Oral AMN107 in Adults With Chronic Myelogenous Leukemia Resistant and/or Intolerant to Imatinib Mesylate Therapy Phase 2/Phase 3
Terminated NCT00306332 - T-cell and B-cell Depletion in Allogeneic Peripheral Blood Stem Cell Transplantation Phase 3
Terminated NCT00058747 - AG-858 in Patients Who Are Cytogenetically Positive After Treatment With Gleevecâ„¢ Phase 2
Active, not recruiting NCT00538447 - Prospective Database for Chronic Myelogenous Leukemia N/A
Terminated NCT01050946 - Hematopoietic Stem Cell Transplantation (HSCT) Using CD34 Selected Mismatched Related Donor and One Umbilical Cord Unit Phase 2
Completed NCT00034684 - Study of Farnesyl Protein Transferase Inhibitor (FPTI) in Patients With Leukemia (Study P00701) Phase 1/Phase 2
Recruiting NCT04260022 - Study of HQP1351 in Subjects With Refractory CML and Ph+ ALL Phase 1
Terminated NCT00167180 - Post Transplant Donor Lymphocyte Infusion Phase 2
Terminated NCT00449761 - Efficacy and Safety of LBH589B in Adult Patients With Refractory Chronic Myeloid Leukemia in Accelerated or Blast Phase Phase 2
Completed NCT00455221 - Safety Assessment of a Multipeptide-gene Vaccine in CML Phase 1
Completed NCT00298987 - A Study of Dasatinib in Patients With Chronic Myelogenous Leukemia Who Are Resistant or Intolerant of Imatinib Mesylate Phase 2
Completed NCT00763763 - Imatinib Mesylate With Vincristine and Dexamethasone in Acute Lymphoblastic Leukemias With BCR-ABL Positive Phase 2