|
Phase I Study of Lonafarnib and Gleevec in Chronic Myelogenous Leukemia Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about Phase I Study of Lonafarnib and Gleevec in Chronic Myelogenous Leukemia conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Phase I Study of Lonafarnib and Gleevec in Chronic Myelogenous Leukemia Clinical research trials and Phase I Study of Lonafarnib and Gleevec in Chronic Myelogenous Leukemia healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as Phase I Study of Lonafarnib and Gleevec in Chronic Myelogenous Leukemia. Phase I Study of Lonafarnib and Gleevec in Chronic Myelogenous Leukemia Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Phase I Study of Lonafarnib and Gleevec in Chronic Myelogenous Leukemia clinical trial. Subjects frequently obtain the most expert healthcare possible for their Phase I Study of Lonafarnib and Gleevec in Chronic Myelogenous Leukemia condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "P" Clinical Trials Conditions > Phase I Study of Lonafarnib and Gleevec in Chronic Myelogenous Leukemia  Phase I Study of Lonafarnib and Gleevec in Chronic Myelogenous Leukemia
Phase I Study of Lonafarnib and Gleevec in Chronic Myelogenous Leukemia
For Condition: Chronic Myelogenous Leukemia
Status: Recruiting
Sponsor(s): M.D. Anderson Cancer Center ,
Synopsis: The purpose of this study if to investigate the effect of lonafarnib (SCH66336) in combination with Gleevec in the treatment of CML.
Details: Existing pre-clinical and clinical data suggest that SCH66336, a farnesyl transferase inhibitor,exhibits significant activity against CML cells, and in fact may have synergistic activity in combination with imatinib mesylate. Thus, the objectives to the study are (1) to determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLT) of lonafarnib (SCH66336), a farnesyl transferase inhibitor, in combination with imatinib mesylate (Gleevec) in patients with chronic phase, accelerated phase, and blast crisis CML; (2) to assess the pharmacokinetics of the combination of lonafarnib and Gleevec in these patients; and (3) to assess in a preliminary way the biologic activity of the combination of lonafarnib and Gleevec in these patients.
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 16 Years/
Genders: Both
Protocol Entry Criteria: 1. Patients with Philadelphia chromosome (ph) positive CML in any of the following categories: (a) Chronic phase patients must have failed therapy with Gleevec. Failure will be defined as: (i) Patients who have not achieved or have lost their hematologic response at 3 months from the start of therapy with Gleevec, or (ii) Patients who have not achieved or have lost their cytogenetic response after 6 months of therapy with Gleevec, or (iii) Patients who have not achieved or have lost their major cytogenetic response after 12 months of therapy with Gleevec. (b) Patients in accelerated phase, defined as the presence of any of the following features: (i) blasts in peripheral blood (PB) or bone marrow (BM) >/= 15% (but < 30%), (ii) blasts + promyelocytes in PB or BM >/= 30%, (iii) basophils in PB or BM >/= 20%, (iv) platelets < 100 x 10e9/L unrelated to therapy, (v) clonal evolution. (c) Patients in blast phase, defined by the presence of >/= 30% blasts in peripheral blood and/or bone marrow, or the presence of extramedullary disease. 2) Patients in accelerated or blastic phase are eligible whether they have received and/or failed Gleevec or not. 3) Age >/= 16 years. 4) Patients must sign an informed consent indicating that they are aware of the investigational nature of this study in keeping eith the policies of the hospital. The only acceptable consent form is attached at the end of the protocol. 5) Performance status 500 msec. (b) Patients with severe heart disease (cardiac class III and IV) will be excluded.
Total Enrollment: 75
Location and Contact Information:
M.D. Anderson Cancer Center *Recruiting*
Houston, Texas, 77030
United States
Recruiting Jorge Cortes 713-794-5783
Additional Information:
Study ID Numbers: ID02-221;
Study Start Date: October 2002
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00047502
Other Chronic Myelogenous Leukemia Studies:
1. Dose-Determining Study of R115777 for Childhood Leukemia
2. Vaccine Therapy Plus Immune Adjuvant in Treating Patients With Chronic Myeloid Leukemia, Acute Myeloid Leukemia, or Myelodysplastic Syndrome
3. R115777 in Treating Patients With Myeloproliferative Disorders
4. Radiolabeled Monoclonal Antibody Therapy and Etoposide Followed by Peripheral Stem Cell Transplantation in Treating Patients With Advanced Myelodysplastic Syndrome or Refractory Leukemia
5. Fluconazole Compared With Voriconazole in Preventing Invasive Fungal Infections in Patients Undergoing Allogeneic Hematopoietic Transplantation
Related Studies:
Other Chronic Myelogenous Leukemia Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Phase I Study of Lonafarnib and Gleevec in Chronic Myelogenous Leukemia
|
|
|
|
|
|
|
|
