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Dose-Escalating and Safety Study of CP-461 in Patients with Chronic Lymphocytic Leukemia Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Dose-Escalating and Safety Study of CP-461 in Patients with Chronic Lymphocytic Leukemia conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Dose-Escalating and Safety Study of CP-461 in Patients with Chronic Lymphocytic Leukemia Clinical research trials and Dose-Escalating and Safety Study of CP-461 in Patients with Chronic Lymphocytic Leukemia medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Dose-Escalating and Safety Study of CP-461 in Patients with Chronic Lymphocytic Leukemia. Dose-Escalating and Safety Study of CP-461 in Patients with Chronic Lymphocytic Leukemia Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Dose-Escalating and Safety Study of CP-461 in Patients with Chronic Lymphocytic Leukemia clinical trial. Subjects often receive the most expert healthcare possible for their Dose-Escalating and Safety Study of CP-461 in Patients with Chronic Lymphocytic Leukemia condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "D" Clinical Trials Conditions > Dose-Escalating and Safety Study of CP-461 in Patients with Chronic Lymphocytic Leukemia  Dose-Escalating and Safety Study of CP-461 in Patients with Chronic Lymphocytic Leukemia
Dose-Escalating and Safety Study of CP-461 in Patients with Chronic Lymphocytic Leukemia
For Condition: Chronic Lymphocytic Leukemia
Status: Completed
Sponsor(s): Cell Pathways ,
Synopsis: The purposes of this study are to determine a maximum tolerated dose and to evaluate the safety and efficacy of CP-461 in patients with Chronic Lymphocytic Leukemia.
Details:
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: 1. Relapsed or refractory chronic lymphocytic leukemia. 2. Patients must have either intermediate or high risk chronic lymphocytic leukemia according to the Rai Staging System. 3. Must have failed at least 1 prior chemotherapy regimen (at least 1 of which included fludarabine) for CLL. 4. No prior therapy within 4 weeks prior to entering the study. Patients must have fully recovered from the acute effects of prior therapy. 5. Platelet count = 75,000/mm3 , hemoglobin = 8 gm/dL. 6. Expected remaining life span > or = three months. 7. ECOG performance status 0 – 2. 8. 18 years or of legal age. 9. Male patients or non-pregnant and non-lactating female patients, who are either using adequate birth control, are surgically sterile or post-menopausal. 10. Negative serum pregnancy test, if fertile female. 11. Willingness and ability to sign an informed consent document. Exclusion Criteria: 1. Evidence of CNS involvement. 2. Other active malignancy or history of treatment of any malignancy (excluding non-melanoma skin cancer) within the previous three years. 3. Previous therapy with Campath. 4. Patients with low-risk chronic lymphocytic leukemia according to the Rai Staging System. 5. Concurrent immunotherapy. 6. Concurrent use of steroids. 7. Use of an investigational medication or device within 1 month of initiating study therapy. 8. Patients who have had allogeneic bone marrow transplantation. 9. Total serum bilirubin above the upper limit of normal; serum creatinine above the upper limit of normal. 10. AST or ALT > 2.5 times the upper limit of normal. 11. Any condition or any medication which may interfere with the conduct of the study.
Total Enrollment: 15
Location and Contact Information:
Cancer Centers of Florida
Orlando, Florida, 32806
United States
Cancer Care Northwest
Spokane, Washington, 99218
United States
Tyler Cancer Center
Tyler, Texas, 75702
United States
Albany Regional Cancer Center
Albany, New York, 12208
United States
Mary Crowley Medical Research Center (US Oncology)
Dallas, Texas, 75246
United States
Additional Information:
Study ID Numbers: CP 461-010;
Study Start Date: March 2002
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00036257
Other Chronic Lymphocytic Leukemia Studies:
1. Tipifarnib in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
2. Phase I Study of BL22, a Recombinant Immunotoxin for Treatment of CD22+ Leukemias and Lymphomas
3. UCN-01 and Fludarabine to Treat Lymphoma and Leukemia
4. Monoclonal Antibody in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
5. Phase I Study of Anti-Tac(Fv)-PE38 (LMB-2), a Recombinant Single-Chain Immunotoxin for Treatment of Tac-Expressing Malignancies
Related Studies:
Other Chronic Lymphocytic Leukemia Clinical Trials
Other Florida Clinical Trials
Other Orlando Clinical Trials
Dose-Escalating and Safety Study of CP-461 in Patients with Chronic Lymphocytic Leukemia
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