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Safety and Efficacy of Hum195/rGel in Patients with Advanced Myeloid Malignancies Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Safety and Efficacy of Hum195/rGel in Patients with Advanced Myeloid Malignancies conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Safety and Efficacy of Hum195/rGel in Patients with Advanced Myeloid Malignancies Clinical research trials and Safety and Efficacy of Hum195/rGel in Patients with Advanced Myeloid Malignancies healthcare trials take place in many of cities across 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 generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Safety and Efficacy of Hum195/rGel in Patients with Advanced Myeloid Malignancies. Safety and Efficacy of Hum195/rGel in Patients with Advanced Myeloid Malignancies Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Safety and Efficacy of Hum195/rGel in Patients with Advanced Myeloid Malignancies clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Safety and Efficacy of Hum195/rGel in Patients with Advanced Myeloid Malignancies condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Safety and Efficacy of Hum195/rGel in Patients with Advanced Myeloid Malignancies  Safety and Efficacy of Hum195/rGel in Patients with Advanced Myeloid Malignancies
Safety and Efficacy of Hum195/rGel in Patients with Advanced Myeloid Malignancies
For Condition: Myeloproliferative Disorders,Leukemia, Myelocytic, Acute,Myelodysplastic Syndromes,Anemia, Refractory, with Excess of Blasts
Status: Recruiting
Sponsor(s): M.D. Anderson Cancer Center ,
Synopsis: The goal of this clinical research study is to find the highest safe dose of the anti-CD33 immunotoxin Hum-195/rGel that can be given to patients with advanced myeloid malignancies. This treatment will be given to patients whose leukemia has not responded to prior chemotherapy.
Details:
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Patients with relapsed or refractory AML, RAEB-t, RAEB, or CMML who failed at least one previous chemotherapy course. Patients with accelerated CMLPh+ or myeloid blast crisis are eligible. Patients in blastic phase of non-Philadelphia chromosome+ myeloproliferative disorders are also eligible, (blast phase of: 1)P. vera, 2)myelofibrosis, 3)essential thrombocytopenia with >30% blasts in the blood or bone marrow.) - Male or female 18 years of age or older who have provided written informed consent. - Tumor cells must be equal to or greater than 80% CD33 positive by flow cytometry. - For women of childbearing potential (i.e., exclude post-menopausal women, women who have been surgically sterilized) adequate birth control methods must be used. Acceptable birth control methods are limited to oral contraceptives, implants, diaphragm, IUD or spermicide used with a condom. - White blood cell count <10,000/ul for AML, MDS, CML Ph+ in myeloid blastic crisis and myeloproliferative disorders and up to 30,000 for accelerated CML. - No chemotherapy for the two weeks prior to entering the study. - No evidence of residual toxic effects from prior chemotherapy. - Patients with proven bacterial infection are not eligible until resolution of the infection (patient afebrile, not on steroids). Patients with active fungal infections are eligible only if evidence of response to antifungal medications is documented and they do not have fever exceeding 38 degrees C. - Patients should have the following organ function prior to inclusion into the study: - Creatinine - Patients should have values equal to or less than 1.5 times the upper limit of laboratory normal values. - Liver function: Patients should have serum bilirubin values of equal to or less than 2.0 times the upper limit of laboratory values. Patients should have SGOT and SGPT levels equal to or less than 2.0 times the upper limit of laboratory normal values. - Cardiac Function: Patients with cardiovascular disease should be
Total Enrollment: 36
Location and Contact Information:
M.D. Anderson Cancer Center *Recruiting*
Houston, Texas, 77030
United States
Recruiting Moshe Talpaz
Additional Information:
Study ID Numbers: DM98-342;
Study Start Date: June 1999
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00038051
Other Myeloproliferative Disorders Studies:
1. Safety and Efficacy of Hum195/rGel in Patients with Advanced Myeloid Malignancies
2. Experimental Bone Marrow Transplant Protocol
3. Sirolimus to Prevent GVHD after Stem Cell Transplant for Blood Cancers
Related Studies:
Other Myeloproliferative Disorders Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Safety and Efficacy of Hum195/rGel in Patients with Advanced Myeloid Malignancies
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